11.120.01 - Pharmaceutics in general
ICS 11.120.01 Details
Pharmaceutics in general
Pharmazie im allgemeinen
Pharmacie en general
Farmacija na splošno
General Information
Frequently Asked Questions
ICS 11.120.01 is a classification code in the International Classification for Standards (ICS) system. It covers "Pharmaceutics in general". The ICS is a hierarchical classification system used to organize international, regional, and national standards, facilitating the search and identification of standards across different fields.
There are 89 standards classified under ICS 11.120.01 (Pharmaceutics in general). These standards are published by international and regional standardization bodies including ISO, IEC, CEN, CENELEC, and ETSI.
The International Classification for Standards (ICS) is a hierarchical classification system maintained by ISO to organize standards and related documents. It uses a three-level structure with field (2 digits), group (3 digits), and sub-group (2 digits) codes. The ICS helps users find standards by subject area and enables statistical analysis of standards development activities.
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This document specifies the application of simplified accelerated stress simulation methods for stress tests of finished products, used in and as Traditional Chinese medicine (TCM). Testing for stability or degradation under the influence of daylight or sunlight is outside the scope of this document.
- Standard23 pagesEnglish languagesale 15% off
SCOPE
1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using the principles of quality by design (QbD) (Juran, 1992;2 ICH Q8). The framework is applicable to both drug substance (DS) and drug product (DP) manufacturing. High (detailed) level process understanding can be used to facilitate production of product which consistently meets required specifications. It can also play a key role in continual process improvement efforts.
1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined to be critical to a process. It is important for the reader to recognize that PAT is defined as:
“…a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in process materials and processes, with the goal of ensuring final product quality. It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner. The goal of PAT is to enhance understanding and control the manufacturing process…” (USFDA PAT)
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Guide7 pagesEnglish languagesale 15% off
- Guide7 pagesEnglish languagesale 15% off
This document specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This document is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.
- Standard22 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
5.1 These methods are intended to determine whether a material, product, or part of a product has the degree of radiopacity desired for its application as a medical device in the human body. This method allows for comparison with or without the use of a body mimic. Comparisons without the use of a body mimic should be used with caution as the relative radiopacity can be affected when imaging through the human body.
5.2 These methods allow for both qualitative and quantitative evaluation in different comparative situations.
SCOPE
1.1 These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography), and DEXA (dual energy X-ray absorptiometry), also known as DXA, The results of these measurements are an indication of the likelihood of locating the product within the human body.
1.2 Radiopacity is determined by (a) qualitatively comparing image(s) of a test specimen and a user-defined standard, with or without the use of a body mimic; or (b) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test specimen and the image of a user-defined standard, with or without the use of a body mimic.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard6 pagesEnglish languagesale 15% off
- Standard6 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 Although some CM is used in the pharmaceutical industry (for example, purified water production), and some processes are inherently continuous individual unit operations (such as dry granulation and compression), these operations are generally operated in isolation and do not deliver the potential benefits of an integrated CM operation. The FDA Guidance for Industry PAT document specifically identifies that the introduction of continuous processing (now redefined as CM) may be one of the outcomes from the adoption of a science-based approach to process design.
4.2 This guide does not:
4.2.1 Suggest that CM is suitable for the manufacture of all pharmaceutical products.
4.2.2 Provide guidance on issues related to the safe operation of a CM process or continuous processing equipment. It is the responsibility of the user of this standard to establish appropriate health and safety practices and determine the applicability of regulatory limitations prior to use.
4.2.3 Recommend particular designs or operating regimes for CM.
4.3 Appendix X1 includes a table comparing the characteristics of continuous and discrete or batch processes.
SCOPE
1.1 This guide introduces key concepts and principles to assist in the appropriate selection, development and operation of CM technologies for the manufacture of pharmaceutical products. Athough selected concepts covered here can be applied to biopharmaceutical CM (BioCM), the focus of this guide is on non-biopharmaceutical applications.
1.2 Particular consideration is given to the development and application of the appropriate scientific understanding and engineering principles that differentiate CM from traditional batch manufacturing.
1.3 Most of the underlying concepts and principles (for example, process dynamics and process control) outlined in this guide can be applied to both Drug Substance (DS) and Drug Product (DP) processes. However, it should be recognized that in Drug Substance production the emphasis may be more on chemical behavior and dynamics in a fluid phase whereas for solid drug product manufacture there may be a greater emphasis on the physical behavior and dynamics in a solid/powder format.
1.4 This guide is also intended to apply in both the development of new processes, or the redesign of existing ones.
1.5 All values are stated in SI units. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Guide17 pagesEnglish languagesale 15% off
- Guide17 pagesEnglish languagesale 15% off
SCOPE
1.1 This standard covers terminology used by the E55 Committee relating to pharmaceutical and biopharmaceutical industry for manufacture of pharmaceutical and biopharmaceutical products. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to pharmaceutical and biopharmaceutical manufacturing may be more clearly stated.
1.2 This terminology is, therefore, intended to be selective of terms used generally in the manufacture of pharmaceutical and biopharmaceutical products and published in a number of documents such as those listed in the succeeding section. The listing is also intended to define terms that appear prominently within other related ASTM International standards and do not appear elsewhere.
1.3 The definitions are substantially identical to those published by regulatory agencies such as the U.S. Food and Drug Administration, European Medicines Agency, Pharmaceutical and Medical Devices Agency (Japan), other and national competent authorities (human) as well as other authoritative bodies, such as ICH, ISO, and national standards organizations.
1.4 This terminology supplements current documents on terminology that concentrate on the manufacture of pharmaceutical and biopharmaceutical products.
1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with the manufacture of pharmaceutical and biopharmaceutical products.
1.6 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard16 pagesEnglish languagesale 15% off
- Standard16 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 This guide focuses on upstream and downstream processes for biopharmaceutical products with a particular focus on antibody production processes. For further information, see Appendix X1 and Refs (1-3).
4.2 Bioprocesses traditionally consist of discrete unit operations labeled as upstream, downstream, and fill/finish operations. The objectives at each stage are significantly different, as are the operating parameters and control processes, that can make complete integration impractical initially (Appendix X1). This guide does not imply that complete integration is a prerequisite. A higher degree of integration may be possible over time as a better understanding of the dynamics of processes become established.
4.2.1 Upstream Processes—The purpose of upstream processes is to generate sufficient product to meet patient requirements preferably in the fewest number of batches. This starts with increasing biomass (cell-line expansion from working cell bank to production inoculation) to a production bioreactor in which the focus shifts to producing product. The material within a bioreactor during extended growth is heterogenous, for example, cells will differ in age, there may be genetic drift, secreted product can differ in the residence time spent in the bioreactor, and cell debris accumulates throughout the process.
4.2.2 Downstream Processes—The purpose of downstream processes is to harvest product and purify it from process- and product-related impurities (for example, cell debris, nucleic acids, and misfolds) to the desired level. Solids are first separated from solutes; solutes are then separated from each other in the process of purification. Certain processes may at best be semi-continuous, and some steps may be prone to fouling, which may require manual intervention.
4.2.3 Fill/Finish Operations—The purpose of fill/finish operations is to formulate the purified product in a form that ensures stability and sterility and provides a dosage form consis...
SCOPE
1.1 This guide is intended as a complement to Guide E2968. It provides key concepts and principles to assist in the appropriate selection, development, and operation of continuous processing technologies for the manufacture of biologically derived products.
1.2 Several of the principles covered in Guide E2968 are applicable to biomanufacturing. However, processes for biologically derived products differ from those for synthetic drugs in a number of fundamental ways in addition to their source (for example, format: aqueous liquids versus powders; scope: genesis to final formulation). This guide is intended to provide greater clarity for biomanufacturing. It does not imply that topics in Guide E2968 that are not covered here do not apply to continuous manufacturing (CM) for biologics.
1.3 Biologically derived products also differ widely from each other in terms of modalities, source materials, and the manufacturing technologies used, not all of which are equally amenable to operating in a continuous mode.
1.4 Opportunities do exist for the introduction of continuous technologies, for example, efforts are ongoing to adapt processes for large-scale manufacture of broadly applicable modalities such as monoclonal antibodies to a continuous format. This guide is intended to provide guidance to the design and implementation of antibody processes.
1.5 The principles can be applicable to unit operations or processes or both for other modalities but may not be applicable to all bioprocesses.
1.6 Particular consideration should be given to the development and application of the appropriate scientific understanding and engineering principles that differentiate CM from traditional batch manufacturing.
1.7 Since much of the processing is done under conditions amenable to microbial growth, maintaining process streams free from external biological impurities and microbial contamination (for example, bioburden, viruses, ...
- Guide16 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 Application of the approach described within this practice applies the science-based, risk-based, and statistics-based concepts and principles introduced in Guides E3106 and E3219.
4.2 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the inspection of equipment for cleanliness in accordance with 21 CFR 211.67(b)(6) and is in accordance with FDA Process Validation Guidance Life Cycle approach.
4.3 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with European Medicines Agency (EMA) Annex 15.
4.4 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with the EMA’s Q&A Guidance (Q&A’s #7 and #8) (2).
4.5 Visual Inspection used as described in 4.4 should only be used in situations where there is a suitable safety margin between the VRL and MSSR and robust detectability at the VRL.
4.6 Application of the approach described within this practice applies the risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality, and documentation for validation (including cleaning validation) should also be commensurate with the level of risk.
4.7 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for releasing manufacturing equipment and manufactured medical devices or cleanliness that is compatible with the U.S. FDA Guidance for Industry, PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.
4.8 Key Concepts—This practice applies the following key concepts: (1) visual inspection, (2) quality risk management, (3) science-based appr...
SCOPE
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for residues.
1.2 This practice applies to pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies) and medical devices following all manufacturing and cleaning. This practice is also applicable to other health, cosmetics, and consumer products.
1.3 This practice applies to many types of chemical residues (including APIs, intermediates, cleaning agents, processing aids, machining oils, and so forth) that could remain on manufacturing equipment surfaces or medical devices that have undergone all manufacturing steps including cleaning.
1.4 This practice applies only to equipment or devices that have been justified through a Quality Risk Management program to have an acceptable hazard analysis, have cleaning processes that are repeatable and validated and where Visual Inspection can be relied upon to determine the cleanliness of the equipment at the residue limit justified by the HBEL.
1.5 The values stated in International System of Units (SI) units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommend...
- Standard21 pagesEnglish languagesale 15% off
This document gives an overview of recommendations on product specifications, and other relevant information, for algae and algae products for pharmaceutical applications.
This document does not apply to food and feed applications.
This document does not provide instructions on handling of technical requirements in existing legislations.
- Technical report39 pagesEnglish languagee-Library read for1 day
This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as:
a) contamination by bacteria, moulds or yeasts;
b) contamination by viruses;
c) contamination by agents causing transmissible spongiform encephalopathies (TSE);
d) material responsible for undesired pyrogenic, immunological or toxicological reactions.
For parasites and other unclassified pathogenic entities, similar principles can apply.
This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids.
This document does not specify a quality management system for the control of all stages of production of medical devices.
This document does not cover the utilization of human tissues in medical devices.
NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
NOTE 2 For guidance on the application of this document, see Annex A.
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This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442‑1.
NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.
This document does not cover the utilization of human tissues in medical devices.
This document does not specify a quality management system for the control of all stages of production of medical devices.
- Standard26 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
4.1 A significant amount of data is generated during pharmaceutical development and manufacturing activities. The interpretation of such data is becoming increasingly difficult. Individual examination of the univariate process variables is relevant but can be significantly complemented by multivariate data analysis (MVDA). MVDA may be particularly appropriate for exploring and handling large sets of heterogenous data, mapping data of high dimensionality onto lower dimensional representations, exposing significant correlations among multivariate variables within a single data set or significant correlations among multivariate variables across data sets. MVDA may extract statistically significant information which may enhance process understanding, decision making in process development, process monitoring and control (including product release), product life-cycle management, and continuous improvement.
4.2 MVDA is widely used in various industries including the pharmaceutical industry. To achieve a valid outcome, an MVDA model/application should incorporate the following:
4.2.1 A predefined risk-based objective incorporating one or more relevant scientific hypotheses specific to the application;
4.2.2 Sufficient relevant data of requisite quality covering the variance space encountered during intended use, that is, pharmaceutical development, or pharmaceutical manufacturing, or both;
4.2.3 Appropriate data analysis and model utilization practices including considerations on testing, validation, and qualification of all new data prior to using a model to analyze it;
4.2.4 Appropriately trained staff;
4.2.5 Appropriate standard operating procedures; and
4.2.6 Life-cycle management.
4.3 This guide can be used to support data analysis activities associated with pharmaceutical development and manufacturing, process performance and product quality monitoring in manufacturing, as well as for troubleshooting and investigation events. Technical detai...
SCOPE
1.1 This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process understanding and decision making in pharmaceutical development, and for the release of intermediate and final products after being validated appropriately using a science and risk-based approach.
1.2 The scope of this guide is to provide general guidelines on the application of MVDA in the pharmaceutical industry. While MVDA refers to typical empirical data analysis, the scope is limited to providing a high level guidance and not intended to provide application-specific data analysis procedures. This guide provides considerations on the following aspects:
1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status);
1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers);
1.2.3 Considerations on the different types of data analysis, model testing, and validation;
1.2.4 Qualified and competent personnel; and
1.2.5 Life-cycle management of MVDA model.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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- Guide7 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 Application of the approach described within this standard guide applies science-based concepts and principles introduced in the FDA’s initiative on pharmaceutical CGMPs for the 21st century.4
4.2 This guide supports, and is consistent with, elements from ICH Q8 – Q11 and guidelines from USFDA, European Commission, Pharmaceutical Inspection Co-operation Scheme, and the China Food and Drug Administration.8
4.3 According to FDA Guidance for Industry, PAT, “With real time quality assurance, the desired quality attributes are ensured through continuous assessment during manufacture. Data from production batches can serve to validate the process and reflect the total system design concept, essentially supporting validation with each manufacturing batch.” In other words, the accumulated product and process understanding used to identify the Critical Quality Attributes (CQAs), together with the control strategy, will enable control of the CQAs, providing the confidence needed to show validation with each batch. This is as opposed to a traditional discrete process validation approach.
SCOPE
1.1 This guide describes Continuous Process Verification as an alternate approach to process validation where manufacturing process (or supporting utility system) performance is continuously monitored, evaluated, and adjusted (as necessary). It is a science-based approach to verify that a process is capable and will consistently produce product meeting its predetermined critical quality attributes. Continuous Process Verification (ICH Q8) is similarly described as Continuous Quality Verification.
1.2 Pharmaceutical and biopharmaceutical product manufacturing companies are required to provide assurance that the processes used to manufacture regulated products result in products with the specified critical quality attributes of strength identity and purity associated with the product safety and efficacy. Process validation is a way in which companies provide that assurance.
1.3 With the knowledge obtained during the product lifecycle, a framework for continuous quality improvements will be established where the following may be possible: (1) risk identified, (2) risk mitigated, (3) process variability reduced, (4) process capability enhanced, (5) process design space defined or enhanced, and ultimately (6) product quality improved. This can enable a number of benefits that address both compliance and operational goals (for example, real time release, continuous process improvement).
1.4 The principles in this guide may be applied to drug product or active pharmaceutical ingredient/drug substance pharmaceutical and biopharmaceutical batch or continuous manufacturing processes or supporting utility systems (for example, TOC for purified water and water for injection systems, and so forth).
1.5 The principles in this guide may be applied during the development and manufacturing of a new process or product or for the improvement or redesign, or both, of an existing process.
1.6 Continuous process verification may be applied to manufacturing processes that use monitoring systems that provide frequent and objective measurement of process data in real time. These processes may or may not employ in-, on-, or at-line analyzers/controllers that monitor, measure, analyze, and control the process performance. The associated processes may or may not have a design space.
1.7 This guide may be used independently or in conjunction with other proposed E55 standards to be published by ASTM International.
- Guide5 pagesEnglish languagesale 15% off
- Guide5 pagesEnglish languagesale 15% off
This European Standard specifies symbols for use in the information supplied by the manufacturer with medical devices. The requirements of this European Standard are not intended to apply to symbols specified in other standards. However, every effort should be made to prevent the specifying of different symbols with the same meaning. This standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 375, EN 376, EN 591, EN 592 and EN 1041.
- Amendment11 pagesEnglish languagee-Library read for1 day
This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.
This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).
NOTE When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.
- Standard12 pagesEnglish languagee-Library read for1 day
This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive 93/42/EEC Section 7.5, 2nd paragraph. This specifically includes the format of a symbol to be used in the labelling. This European Standard does not specify the requirements for information to be supplied with medical devices, which are addressed by EN 980 and EN 1041.
This European Standard does not specify the requirements of the 1st and of the 3rd paragraphs of Essential Requirement 7.5.
- Standard12 pagesEnglish languagee-Library read for1 day
ISO 22442-3:2007 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents.
- Standard31 pagesEnglish languagee-Library read for1 day
Establishes definitions, requirements, methods of testing and rated values for phase-to-earth capacitive and screen-to-earth intrusive inductive coupling devices to be used in medium voltage DLC systems.
- Standard21 pagesEnglish languagee-Library read for1 day
This document provides requirements and recommendations related to the concepts required to associate pharmaceutical products or groups of pharmaceutical products with an appropriate set of PhPID(s) in accordance with ISO 11616.
Pharmaceutical product identifiers and the related elements are intended to represent pharmaceutical products as defined within a medicinal product by a medicines regulatory authority. While the ISO standards on IDMP can be applied to off-label usage of medicinal products, such applications are currently outside of the scope of this document.
Reference to ISO 11238, ISO 11239, ISO 11240, ISO 11615, HL7 V3 messaging standards (HL7 Reference Information Model (RIM)[8], HL7 Common Product Model (CPM)[9] and HL7 V3 Structured Product Labelling (SPL)[10], and HL7 FHIR[11] can be applied for pharmaceutical product information in the context of this document.
- Draft72 pagesEnglish languagee-Library read for1 day
SIGNIFICANCE AND USE
4.1 Application of the approach described within this practice applies the science-based, risk-based, and statistics-based concepts and principles introduced in Guides E3106 and E3219.
4.2 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the inspection of equipment for cleanliness in accordance with 21 CFR 211.67(b)(6) and is in accordance with FDA Process Validation Guidance Life Cycle approach.
4.3 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with European Medicines Agency (EMA) Annex 15.
4.4 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with the EMA’s Q&A Guidance (Q&A’s #7 and #8) (2).
4.5 Visual Inspection used as described in 4.4 should only be used in situations where there is a suitable safety margin between the VRL and MSSR and robust detectability at the VRL.
4.6 Application of the approach described within this practice applies the risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality, and documentation for validation (including cleaning validation) should also be commensurate with the level of risk.
4.7 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for releasing manufacturing equipment and manufactured medical devices or cleanliness that is compatible with the U.S. FDA Guidance for Industry, PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.
4.8 Key Concepts—This practice applies the following key concepts: (1) visual inspection, (2) quality risk management, (3) science-based appr...
SCOPE
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for residues.
1.2 This practice applies to pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies) and medical devices following all manufacturing and cleaning. This practice is also applicable to other health, cosmetics, and consumer products.
1.3 This practice applies to many types of chemical residues (including APIs, intermediates, cleaning agents, processing aids, machining oils, and so forth) that could remain on manufacturing equipment surfaces or medical devices that have undergone all manufacturing steps including cleaning.
1.4 This practice applies only to equipment or devices that have been justified through a Quality Risk Management program to have an acceptable hazard analysis, have cleaning processes that are repeatable and validated and where Visual Inspection can be relied upon to determine the cleanliness of the equipment at the residue limit justified by the HBEL.
1.5 The values stated in International System of Units (SI) units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommend...
- Standard21 pagesEnglish languagesale 15% off
- Standard21 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
5.1 These methods are intended to determine whether a material, product, or part of a product has the degree of radiopacity desired for its application as a medical device in the human body. This method allows for comparison with or without the use of a body mimic. Comparisons without the use of a body mimic should be used with caution as the relative radiopacity can be affected when imaging through the human body.
5.2 These methods allow for both qualitative and quantitative evaluation in different comparative situations.
SCOPE
1.1 These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography), and DEXA (dual energy X-ray absorptiometry), also known as DXA, The results of these measurements are an indication of the likelihood of locating the product within the human body.
1.2 Radiopacity is determined by (a) qualitatively comparing image(s) of a test specimen and a user-defined standard, with or without the use of a body mimic; or (b) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test specimen and the image of a user-defined standard, with or without the use of a body mimic.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
- Standard6 pagesEnglish languagesale 15% off
- Standard6 pagesEnglish languagesale 15% off
SIGNIFICANCE AND USE
4.1 Application of the approach described within this practice applies the science-based, risk-based, and statistics-based concepts and principles introduced in Guides E3106 and E3219.
4.2 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the inspection of equipment for cleanliness in accordance with 21 CFR 211.67(b)(6).
4.3 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with European Medicines Agency (EMA) Annex 15 (2).
4.4 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for qualifying the visual inspection of equipment for cleanliness in accordance with the EMA’s Q&A Guidance (Q&A’s #7 and #8) (2).
4.5 Application of the approach described within this practice applies the risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality, and documentation for validation (including cleaning validation) should also be commensurate with the level of risk.
4.6 Application of the approach described within this practice provides a science-, risk-, and statistical-based approach for releasing manufacturing equipment and manufactured medical devices or cleanliness that is compatible with the U.S. FDA Guidance on Process Analytical Technology Initiative (3).
4.7 Key Concepts—This practice applies the following key concepts: (1) visual inspection, (2) quality risk management, (3) science-based approach, (4) statistics-based approach, and (5) process knowledge and understanding.
SCOPE
1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of pharmaceutical manufacturing equipment surfaces and medical devices for residues.
1.2 This practice applies to pharmaceuticals [including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies] and medical devices following all manufacturing and cleaning. This practice is also applicable to other health, cosmetics, and consumer products.
1.3 This practice applies to all types of chemical residues (including APIs, intermediates, cleaning agents, processing aids, machining oils, and so forth) that could remain on manufacturing equipment surfaces or medical devices that have undergone all manufacturing steps including cleaning.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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SCOPE
1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using quality by design (QbD) (Juran, 1992;2 FDA/ICH Q8). The framework is applicable to both active pharmaceutical ingredient (API) and to drug product (DP) manufacturing. High (detailed) level process understanding can be used to facilitate production of product which consistently meets required specifications. It can also play a key role in continuous process improvement efforts.
1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined to be critical to a process. It is important for the reader to recognize that PAT is defined as:
“…a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in process materials and processes, with the goal of ensuring final product quality. It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner. The goal of PAT is to enhance understanding and control the manufacturing process…” (U.S. FDA PAT)
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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SIGNIFICANCE AND USE
4.1 Although some continuous processing is used in the pharmaceutical industry (for example, purified water production, inherently continuous individual unit operations such as dry granulation and compression), these operations are generally operated in isolation and do not deliver the potential benefits of an integrated continuous manufacturing operation. The FDA Guidance for Industry PAT document specifically identifies that the introduction of continuous processing may be one of the outcomes from the adoption of a science-based approach to process design.
4.2 This guide does not:
4.2.1 Suggest that continuous production is suitable for the manufacture of all pharmaceutical products.
4.2.2 Provide guidance on issues related to the safe operation of a continuous process or continuous processing equipment. It is the responsibility of the user of this standard to establish appropriate health and safety practices and determine the applicability of regulatory limitations prior to use.
4.2.3 Recommend particular designs or operating regimes for continuous manufacturing.
4.3 Appendix X1 includes a table comparing the characteristics of continuous and discrete or batch processes.
SCOPE
1.1 This guide introduces key concepts and principles to assist in the appropriate selection, development and operation of continuous processing technologies for the manufacture of pharmaceutical products.
1.2 Particular consideration is given to the development and application of the appropriate scientific understanding and engineering principles that differentiate continuous manufacture from traditional batch manufacturing.
1.3 Most of the underlying concepts and principles (for example, process dynamics and process control) outlined in this guide can be applied in both Drug Substance (DS) and Drug Product (DP) processes. However it should be recognized that in Drug Substance production the emphasis may be more on chemical behavior and dynamics in a fluid phase whereas for drug product manufacture there may be a greater emphasis on the physical behavior and dynamics in a solid/powder format.
1.4 This guide is also intended to apply in both the development of a new process, or the improvement/redesign of an existing one.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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SCOPE
1.1 This terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as they are used relative to the PAT framework in the pharmaceutical industry. Terms that are generally understood and in common usage or adequately defined in other readily available eferences are not included except where particular delineation to process analytical technology may be more clearly stated.
1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.
1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other authoritative bodies, such as ISO, IEC, ITU, and national standards organizations.
1.4 This terminology supplements current documents on terminology that concentrate on process analytical technology as it is applied in the pharmaceutical industry.
1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with process analytical technology in the pharmaceutical industry. Section 2 lists those documents referenced in this terminology.
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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SIGNIFICANCE AND USE
4.1 A significant amount of data is being generated during pharmaceutical development and manufacturing activities. The interpretation of such data is becoming increasingly difficult. Individual examination of the univariate process variables is relevant but can be significantly complemented by multivariate data analysis (MVDA). Such methodology has been shown to be particularly efficient at handling large amounts of data from multiple sources, summarizing complex information into meaningful low dimensional graphical representations, identifying intricate correlations between multivariate datasets taking into account variable interactions. The output from MVDA will generate useful information that can be used to enhance process understanding, decision making in process development, process monitoring and control (including product release), product life-cycle management and continual improvement.
4.2 MVDA is a widely used tool in various industries including the pharmaceutical industry. To generate a valid outcome, MVDA should contain the following components:
4.2.1 A predefined objective based on a risk and scientific hypothesis specific to the application,
4.2.2 Relevant data,
4.2.3 Appropriate data analysis techniques, including considerations on validation,
4.2.4 Appropriately trained staff, and
4.2.5 Life-cycle management.
4.3 This guide can be used to support data analysis activities associated with pharmaceutical development and manufacturing, process performance and product quality monitoring in manufacturing, as well as for troubleshooting and investigation events. Technical details in data analysis can be found in scientific literature and standard practices in data analysis are already available (such as Practices E1655 and E1790 for spectroscopic applications, Practice E2617 for model validation and Practice E2474 for utilizing process analytical technology).
SCOPE
1.1 This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process understanding and decision making in pharmaceutical development, and for the release of intermediate and final products.
1.2 The scope of this guide is to provide general guidelines on the application of MVDA in the pharmaceutical industry. While MVDA refers to typical empirical data analysis, the scope is limited to providing a high level guidance and not intended to provide application-specific data analysis procedures. This guide provides considerations on the following aspects:
1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status),
1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers),
1.2.3 Considerations on the different types of data analysis and model validation,
1.2.4 Qualified and competent personnel, and
1.2.5 Life-cycle management of MVDA.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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SIGNIFICANCE AND USE
5.1 These methods are intended to determine whether a material, product, or part of a product has the degree of radiopacity desired for its application as a medical device in the human body. This method allows for comparison with or without the use of a body mimic. Comparisons without the use of a body mimic should be used with caution as the relative radiopacity can be affected when imaging through the human body.
5.2 These methods allow for both qualitative and quantitative evaluation in different comparative situations.
SCOPE
1.1 These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography) and DEXA (dual energy X-ray absorptiometry), also known as DXA, The results of these measurements are an indication of the likelihood of locating the product within the human body.
1.2 Radiopacity is determined by (a) qualitatively comparing image(s) of a test specimen and a user-defined standard, with or without the use of a body mimic, or (b) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test specimen and the image of a user-defined standard, with or without the use of a body mimic.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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- Standard4 pagesEnglish languagesale 15% off
SCOPE
1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using quality by design (QbD) (Juran, 1992; FDA/ICH Q8). The framework is applicable to both active pharmaceutical ingredient (API) and to drug product (DP) manufacturing. High (detailed) level process understanding can be used to facilitate production of product which consistently meets required specifications. It can also play a key role in continuous process improvement efforts.
1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined to be critical to a process. It is important for the reader to recognize that PAT is defined as:
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SIGNIFICANCE AND USE
This guide is intended to aid device fabricators in the selection of proper commercially available polyurethane solids and solutions for their application.
The polyurethanes covered by this guide may be thermoformed or solution cast into biomedical devices for use as surgical aids or for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data.
SCOPE
1.1 This guide covers the evaluation of thermoplastic polyurethanes in both solid and solution form for biomedical applications. The polymers have been reacted to completion and require no further chemical processing.
1.2 The tests and methods listed in this guide may be referenced in specification containing minimum required values and tolerances for specific end-use products.
1.3 Standard tests for biocompatibility are included to aid in the assessment of safe utilization in biomedical applications. Compliance with these criteria shall not be construed as an endorsement of implantability. Since many compositions, formulations, and forms of thermoplastic polyurethanes in solid and solution forms are within this material class, the formulator or fabricator must evaluate the biocompatibility of the specific composition or form in the intended use and after completion of all manufacturing processes including sterilization.
1.4 Purchase specifications may be prepared by agreement between the buyer and seller by selection of appropriate tests and methods from those listed applicable to the specific biomedical end use.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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ABSTRACT
This specification covers the properties for polyethylene plastics for use in medical device applications involving human tissue contact devices, short term indwellings, and fluid transfer devices. Biocompatibility tests must be conducted on the final products as the biocompatibility of these materials as a class has not been established. Plyethylene plastics should consist of basic polymers with ethylene as essentially the sole monomer. The compound may contain optional adjuvant substances required in polymer production or fabrication. The final compound should yield a consistent absorption spectrum characteristic of the established formulation. The polyethylene plastics should be tested using the specified physical test procedures for density, melt flow, tensile properties, compressive properties, stiffness, flexural fatigue, and other flexural properties.
SIGNIFICANCE AND USE
Significance Top
X1.2.1 Concentrations of trace metals are measured as extracts in simulated body fluids. The metal’s concentration in extracts is based on the surface area of the plastic extracted from which the total amount of metal deliverable to the patient may be estimated.
SCOPE
1.1 This specification covers polyethylene plastics (as defined in Terminology D 883) intended for use in medical device applications involving human tissue contact devices, short-term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product.
1.2 This specification is not applicable to ultra-high molecular weight polyethylenes (UHMWPE) plastics, such as those used in joint implants, and so forth.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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SIGNIFICANCE AND USE
Application of the approach described within this standard guide applies science-based concepts and principles introduced in the FDA initiative Pharmaceutical cGMPs for the 21st Century.
This guide supports, and is consistent with, elements from ICH Q8 and ICH Q9.
According to FDA Guidance for Industry, PAT, “With real time quality assurance, the desired quality attributes are ensured through continuous assessment during manufacture. Data from production batches can serve to validate the process and reflect the total system design concept, essentially supporting validation with each manufacturing batch.” In other words, the accumulated product and process understanding used to identify the Critical Quality Attributes (CQAs), together with the knowledge that the risk-based monitoring and control strategy will enable control of the CQAs, should provide the confidence needed to show validation with each batch. This is as opposed to a conventional discrete process validation approach.
SCOPE
1.1 This guide describes Continuous Quality Verification (CQV) as an approach to process validation where manufacturing process (or supporting utility system) performance is continuously monitored, evaluated and adjusted (as necessary). It is a science-based approach to verify that a process is capable and will consistently produce product meeting its predetermined critical quality attributes. CQV is similarly described as Continuous Quality Assurance (U.S. FDA) and Continuous Process Verification (ICH Q8).
1.2 Pharmaceutical and biopharmaceutical product manufacturing companies are required to provide assurance that the processes used to manufacture regulated products result in products with the specified critical quality attributes of strength identity and purity associated with the product safety, and efficacy. Process validation is a way in which companies provide that assurance.
1.3 With the knowledge obtained during the product lifecycle, a framework for continuous quality improvement will be established where the following may be possible: (1) risk mitigated, (2) process variability reduced, (3) process capability enhanced, (4) process design space defined or enhanced, and ultimately (5) product quality improved. This can enable a number of benefits that address both compliance and operational goals (for example, real time release, continuous process improvement).
1.4 The principles in this guide may be applied to drug product or active pharmaceutical ingredient/drug substance pharmaceutical and biopharmaceutical batch or continuous manufacturing processes or supporting utility systems (for example, TOC for Purified Water and Water for Injection systems, and so forth).
1.5 The principles in this guide may be applied during the development and manufacturing of a new process or product or for the improvement and/or redesign of an existing process.
1.6 Continuous quality verification may be applied to manufacturing processes that use monitoring systems that provide frequent and objective measurement of process data. These processes may or may not employ in-, on-, or at-line analyzers/controllers that monitor, measure, analyze, and control the process performance. The associated processes may or may not have a design space.
1.7 This guide may be used independently or in conjunction with other proposed E55 standards to be published by ASTM International.
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This standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).
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SIGNIFICANCE AND USE
These methods are intended to determine whether a material, product, or part of a product has the degree of radiopacity desired for its application as a medical device in the human body.
These methods allow for both qualitative and quantitative evaluation in different comparative situations.
SCOPE
1.1 These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography) and DEXA, also known as DXA, (dual energy X-ray absorptiometry). The results of these measurements are an indication of the likelihood of locating the product within the human body.
1.2 Types of Tests - There are three methods of tests described, differing in the method of determining radiopacity.
1.2.1 Method A - Radiopacity is (1) qualitatively determined by viewing image(s) of a test sample and the image background, with or without the use of a body mimic, or ( 2) quantitatively determined as a specific difference in optical density or pixel intensity between the image of a test sample and the image background, with or without the use of a body mimic.
1.2.2 Method B - Radiopacity is determined by (1) qualitatively comparing image(s) of a test sample and a user-defined standard without the use of a body mimic, or (2) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test sample and the image of a user-defined standard without the use of a body mimic.
1.2.3 Method C - Radiopacity is determined by (1) qualitatively comparing image(s) of a test sample and a user-defined standard with the use of body mimic or (2) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test sample and the image of a user-defined standard with the use of a body mimic.
1.3 The values stated in SI units are to be regarded as the standard.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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ABSTRACT
This practice covers pharmaceutical process design utilizing process analytical technology, which is integral to process development as well as post-development process optimization. It is focused on practical implementation and experimental development of process understanding. The principles in this practice are applicable to both drug substance and drug product processes. For drug products, formulation development and process development are interrelated and therefore the process design will incorporate knowledge from the formulation development. The following practices and methodologies shall be done to attain desired state: risk assessment and mitigation; continuous improvement; process fitness for purpose; intrinsic performance assessment; manufacturing strategy; data collection and formal experimental design; multivariate tools; process analyzers; and process control.
SCOPE
1.1 This practice covers process design, which is integral to process development as well as post-development process optimization. It is focused on practical implementation and experimental development of process understanding.
1.2 The term process design as used in this practice can mean:
1.2.1 The activities to design a process (the process design), and/or
1.2.2 The outcome of this activity (the designed process).
1.3 The principles in this practice are applicable to both drug substance and drug product processes. For drug products, formulation development and process development are interrelated and therefore the process design will incorporate knowledge from the formulation development.
1.4 The principles in this practice apply during development of a new process or the improvement or redesign of an existing one, or both.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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SCOPE
1.1 This terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as they are used relative to the PAT framework in the pharmaceutical industry. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to process analytical technology may be more clearly stated.
1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.
1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other authoritative bodies, such as ISO, IEC, ITU, and national standards organizations.
1.4 This terminology supplements current documents on terminology that concentrate on process analytical technology as it is applied in the pharmaceutical industry.
1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with process analytical technology in the pharmaceutical industry. Section lists those documents referenced in this terminology.
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SCOPE
1.1 This terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as they are used relative to the PAT framework in the pharmaceutical industry. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to process analytical technology may be more clearly stated.
1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.
1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other authoritative bodies, such as ISO, IEC, ITU, and national standards organizations.
1.4 This terminology supplements current documents on terminology that concentrate on process analytical technology as it is applied in the pharmaceutical industry.
1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with process analytical technology in the pharmaceutical industry. Section 2 lists those documents referenced in this terminology.
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SCOPE
1.1 This terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as they are used relative to the PAT framework in the pharmaceutical industry. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to process analytical technology may be more clearly stated.
1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.
1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other authoritative bodies, such as ISO, IEC, ITU, and national standards organizations.
1.4 This terminology supplements current documents on terminology that concentrate on process analytical technology as it is applied in the pharmaceutical industry.
1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with process analytical technology in the pharmaceutical industry. Section 2 lists those documents referenced in this terminology.
- Standard3 pagesEnglish languagesale 15% off
SCOPE
1.1 This terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as they are used relative to the PAT framework in the pharmaceutical industry. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to process analytical technology may be more clearly stated.
1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.
1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other authoritative bodies, such as ISO, IEC, ITU, and national standards organizations.
1.4 This terminology supplements current documents on terminology that concentrate on process analytical technology as it is applied in the pharmaceutical industry.
1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with process analytical technology in the pharmaceutical industry. Section 2 lists those documents referenced in this terminology.
- Standard3 pagesEnglish languagesale 15% off
SCOPE
1.1 This terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as they are used relative to the PAT framework in the pharmaceutical industry. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to process analytical technology may be more clearly stated.
1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.
1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other authoritative bodies, such as ISO, IEC, ITU, and national standards organizations.
1.4 This terminology supplements current documents on terminology that concentrate on process analytical technology as it is applied in the pharmaceutical industry.
1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with process analytical technology in the pharmaceutical industry. Section 2 lists those documents referenced in this terminology.
- Standard3 pagesEnglish languagesale 15% off
SCOPE
1.1 This terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as they are used relative to the PAT framework in the pharmaceutical industry. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to process analytical technology may be more clearly stated.
1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.
1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other authoritative bodies, such as ISO, IEC, ITU, and national standards organizations.
1.4 This terminology supplements current documents on terminology that concentrate on process analytical technology as it is applied in the pharmaceutical industry.
1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with process analytical technology in the pharmaceutical industry. Section 2 lists those documents referenced in this terminology.
- Standard3 pagesEnglish languagesale 15% off
SCOPE
1.1 This terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as they are used relative to the PAT framework in the pharmaceutical industry. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to process analytical technology may be more clearly stated.
1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.
1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other authoritative bodies, such as ISO, IEC, ITU, and national standards organizations.
1.4 This terminology supplements current documents on terminology that concentrate on process analytical technology as it is applied in the pharmaceutical industry.
1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with process analytical technology in the pharmaceutical industry. Section 2 lists those documents referenced in this terminology.
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SIGNIFICANCE AND USE
These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics used in medical devices.
The limitations of the results obtained from this practice should be recognized. The choice of extraction vehicle, duration of immersion, and temperature of the test is necessarily arbitrary. The specification of these conditions provides a basis for standardization and serves as a guide to investigators wishing to compare the relative resistance of various plastics to extraction vehicles.
Correlation of test results with the actual performance or serviceability of materials is necessarily dependent upon the similarity between the testing and end-use conditions (see 12.1.2 and Note 4).
Caution should be exercised in the understanding and intent of this practice as follows:
5.4.1 No allowance or distinction is made for variables such as end-use application and duration of use. Decisions on selection of tests to be done should be made based on Practice F 748.
5.4.2 This practice was originally designed for use with nonporous, solid materials. Its application for other materials, such as those that are porous, or absorptive, or resorptive, should be considered with caution. Consideration should be given to altering the specified material to liquid ratio to allow additional liquid to fully hydrate the material and additional liquid or other methods to fully submerge the test article. Additional procedures that fully remove the extract liquid from the test article, such as pressure or physically squeezing the material, should also be considered as appropriate. Although no definitions are given in this practice for the following terms, such items as extraction vehicle surface tension at the specified extraction condition and plastic specimen physical structure should be taken into account.
Test Methods D 543, D 570, and D 1239 may be useful in providing supplemental information.
SCOPE
1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining "extract liquid" for use in determining the biological response in preclinical testing. Further testing of the "extract liquid" is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined.
1.2 This practice may be used for, but is not limited to the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a referee method for the measurement of extractables in plastics used in medical devices.
1.3 The values stated in SI units are to be regarded as the standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining "extract liquid" for use in determining the biological response in preclinical testing. Further testing of the "extract liquid" is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined.
1.2 This practice may be used for, but is not limited to the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a referee method for the measurement of extractables in plastics used in medical devices.
1.3 The values stated in SI units are to be regarded as the standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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1.1 This test method is designed as a simple and inexpensive initial screening procedure for new compounds with unknown pharmacological properties, or for the comparative bioassay of new members of a chemical series with class reference standards. The test method, which is applicable to most pharmacologically active compounds including pesticides, will properly rank order both acute lethality and potency with a minimum expenditure of test material. It is intended as the first step in a multi-tiered development program.
1.2 This standard does not purport to address the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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1.1 This test method is designed as a simple and inexpensive initial screening procedure for new compounds with unknown pharmacological properties, or for the comparative bioassay of new members of a chemical series with class reference standards. The test method, which is applicable to most pharmacologically active compounds including pesticides, will properly rank order both acute lethality and potency with a minimum expenditure of test material. It is intended as the first step in a multi-tiered development program.
1.2 This standard does not purport to address the safety problems associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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1.1 This guide defines acute animal toxicity tests and sets forth the references for procedures to assess the acute toxicity of water-miscible metalworking fluids as manufactured.
1.2 Although water-miscible metalworking fluids are typically used at high dilution, dilution rates vary widely. Additionally, there is potential for exposure to the metalworking fluid as manufactured.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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1.1 These test methods cover the determination, by radiography, of the radiopacity of plastic in the form of film, sheet, rod, tube, and moldings. The results of these measurements are an indication of the likelihood of locating the plastic part within the human body.
1.2 Types of Tests -There are three methods of tests described, differing in the method of calculating radiopacity.
1.2.1 Method A -Radiopacity is determined as a specific difference in optical density between the image of the plastic and the background on the X-ray film or equivalent.
1.2.2 Method B - Radiopacity is determined by comparing the images of the test piece and of a standard piece simulating the medical device.
1.2.3 Method C -The intrinsic radiopacity of a plastic is determined by measurements made on the image of a slab of a specific thickness of the formulation.
1.3 The values stated in SI units are to be regarded as the standard.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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1.1 This practice covers methods for extraction of medical plastics in liquids that simulate body fluids in their action on the plastics. This practice identifies two methods of extraction: one used for obtaining "extract liquid" to be analyzed by chemical and physical tests; and the other obtaining "extract liquid" for use in determining the biological response of animals. Further testing of the "extract liquid" is specified in other ASTM standards. The plastic after extraction may also be examined.
1.2 This practice may be used for, but is not limited to the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a referee method for the measurement of extractables in plastics used in medical devices.
1.3 The values stated in SI units are to be regarded as the standard.
1.4 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied.
This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography).
NOTE When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.
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ISO 13408-2:2003 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products.
ISO 13408-2:2003 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).
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