11.120.99 (Other standards related to pharmaceutic 标准查询与下载

ASTM E2898-14 基于风险验证PAT应用程序的分析方法的标准指南

4.1 This guide supports the principles of Guide E2500 and extends these principles to validation of analytical methods for PAT applications. The ongoing process of method validation is graphically represented in Fig. 1, which shows the life cycle of the validation of analytical methods for PAT applications. Prerequisites for validation are the identification of the measurement requirements and development of a method to meet those requirements. FIG. 1 Life Cycle for the Validation of Analytical Method for PAT Applications 4.2 The method risk assessment also takes into account the stage in the product life cycle at which the measurements are being made and how the resulting data will be used. The integration of these considerations in the risk assessment facilitates the determination of the level of validation necessary to ensure that the method is fit for purpose. 4.3 Changes may occur during the product life cycle necessitating identification of changes to the measurement requirements and method update and revalidation. Procedures should be established to evaluate the continued suitability of the process analytical method. 4.4 Additional informative examples can be found in Practices D3764, D6122, E1655, E1790, E2056, E2617, and E2656 that address validation of methods and models. Other useful standards include ASME BPE2009, ISO 14971, ISO 15839, and USP Acoustic Emission lt;1005gt; . 1.1 This guide provides an overview to the risk-based validation of process analytical methods under a process analytical technology (PAT) paradigm for pharmaceuticals and biopharmaceuticals and as such includes guidance on assessing risk to product quality from inappropriate method validation. 1.2 This guide builds on existing standards on the topic of validation concentrating on applying such standards to analytical methods for on-line analysis. In particular, it addresses the validation of at-line, on-line, or in-line PAT measurements and covers both API and Drug Product (DP) measurements. 1.3 The definitions of International Conference on Harmonization (ICH) validation parameters (such as specificity, precision, repeatability, etc.) apply; however, the method of demonstrating the validation parameters may vary from that described in ICH and is discussed. 1.4 As consistent with the U.S. Food and Drug Administration (FDA) process validation guidance, this document also briefly covers ongoing assurance that the method remains in a validated state during routine use.

Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

ASTM E2500-13 制药和生物制药生产系统和设备的规范, 设计与验证的标准指南

5.1 Application of the approach described within this guide is intended to satisfy international regulatory expectations in ensuring that manufacturing systems and equipment are fit for intended use, and to satisfy requirements for design, installation, operation, and performance. 5.2 The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach. 5.3 This guide supports, and is consistent with, the framework described in ICH Q8, ICH Q9, ICH Q10, and ICH Q11. 5.4 This guide may be used independently or in conjunction with other E55 standards published by ASTM International. 1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety. 1.2 For brevity, these are referred to throughout the rest of this guide as manufacturing systems. 1.3 This guide may also be applied to laboratory, information, and medical device manufacturing systems. 1.4 This guide is applicable to both new and existing manufacturing systems. The approach may be used for the implementation of changes to existing systems, and their continuous improvement during operation. 1.5 This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement. 1.6 This standard does not address employee health and safety, environmental, or other non-GxP regulations. 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.

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

ASTM E2898-13 PAT应用分析方法的基于风险验证标准指南

4.1 This guide supports the principles of Guide E2500 and extends these principles to validation of analytical methods for PAT applications. The ongoing process of method validation is graphically represented in Fig. 1, which shows the life cycle of the validation of analytical methods for PAT applications. Prerequisites for validation are the identification of the measurement requirements and development of a method to meet those requirements. FIG. 1 Life Cycle for the Validation of Analytical Method for PAT Applications 4.2 The method risk assessment also takes into account the stage in the product life cycle at which the measurements are being made and how the resulting data will be used. The integration of these considerations in the risk assessment facilitates the determination of the level of validation necessary to ensure that the method is fit for purpose. 4.3 Changes may occur during the product life cycle necessitating identification of changes to the measurement requirements and method update and revalidation. Procedures should be established to evaluate the continued suitability of the process analytical method. 4.4 Additional informative examples can be found in Practices D3764, D6122, E1655, E1790, E2056, and E2617 that address validation of methods and models. Other useful standards include ASME BPE2009, ISO 14971, ISO 15839, and USP Acoustic Emission lt;1005gt; . 1.1 This guide provides an overview to the risk-based validation of process analytical methods under a process analytical technology (PAT) paradigm for pharmaceuticals and biopharmaceuticals and as such includes guidance on assessing risk to product quality from inappropriate method validation. 1.2 This guide builds on existing standards on the topic of validation concentrating on applying such standards to analytical methods for on-line analysis. In particular, it addresses the validation of at-line, on-line, or in-line PAT measurements and covers both API and Drug Product (DP) measurements. 1.3 The definitions of International Conference on Harmonization (ICH) validation parameters (such as specificity, precision, repeatability, etc.) apply; however, the method of demonstrating the validation parameters may vary from that described in ICH and is discussed. 1.4 As consistent with the U.S. Food and Drug Administration (FDA) process validation guidance, this document also briefly covers ongoing assurance that the method remains in a validated state during routine use. 1.5 Equipment and instrument qualification are out of the scope of this guide but will be referenced as inputs to validation of analytical methods for PAT applications. 1.6 The validation of multivariate prediction models is out of scope but will be referenced as inputs to validation of analytical methods for PAT applications. 1.7 Microbiological methods are out of scope. 1.8 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility ......

Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications

ASTM E2503-13 筐和桨溶解装置合格标准的标准实施规程

2.1 This practice outlines a procedure for the mechanical calibration of paddle and basket dissolution units to ensure reproducibility of results. 2.2 Once a unit meets all of the mechanical specifications included in this practice, it is considered calibrated and further calibration with dissolution calibrator tablets is not required. 1.1 This practice covers the set-up and calibration of the paddle and basket dissolution apparatus. 1.2 Use of this practice may be applied to apparatus that have been modified to enable automatic dissolution testing (that is, a valve in the bottom of the vessel or sampling through the shaft). 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.

Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus

ASTM D7709-12 医药瓶和泡罩水蒸气透过率(WVTR)测量的标准试验方法

The purpose of these test methods is to obtain reliable values for WVTR that can be used to discriminate among barrier packages for pharmaceutical products. These test methods will establish a WVTR value that represents the water vapor transmission of the container closure system being evaluated. They are intended for use in evaluating or comparing, or both, the water vapor barrier performance of alternative packages for use in packaging of pharmaceutical products. While these methods were developed for a specific, limited application, they should be suitable for most types and sizes of consumer packages.1.1 The three test methods described herein are for measurement of water vapor transmission rates (WVTRs) of high-barrier multiple-unit containers (bottles), high-barrier single-unit containers (blisters), and quasi-barrier single-unit containers used for packaging pharmaceutical products. The containers are tested closed and sealed. These test methods can be used for all consumer-sized primary containers and bulk primary containers of a size limited only by the dimensions of the equipment and the weighing capacity and sensitivity of the balance. 1.2 These test methods are intended to be of sufficient sensitivity and precision to allow clear discrimination among the levels of barrier packages currently available for pharmaceutical products. 1.3 There are three methods: Method A is for bottles, Method B is for formed barrier blisters, and Method C is for formed quasi-barrier blisters. Methods B and C can be adapted for use with flexible pouches. 1.4 These test methods use gravimetric measurement to determine the rate of weight gain as a result of water vapor transmission into the package and subsequent uptake by a desiccant enclosed within the package. The packages are exposed to environments typical of those used for accelerated stability testing of drug products in the package (typically 40°C/75 % relative humidity [RH]). 1.5 For these methods, balance sensitivity, amount of desiccant, number of blisters per test unit, and weighing frequency were developed in an experiment based on Test Methods E96/E96M. 1.6 Test Methods E96/E96M gives specific instruction on the interactions among weighing frequency, number of data points necessary to establish steady state, minimum weight gain in a weighing period, and balance sensitivity. 1.7 The test methods in this standard were developed specifically for pharmaceutical bottles and blisters as closed container-closure systems. The experiment from which the methods were developed provided an inter-laboratory study from which the precision and bias statement was written. The packages in the study were small bottles and blisters used regularly for pharmaceutical solid oral dosage forms. 1.8 In spite of the specific nature of their application, the test methods in this standard should be suitable for other pharmaceutical packages and most types and sizes of other consumer packages. 1.9 The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. The units of measure for bottles are milligrams per bottle per day (mg/bottle-day) and for blisters, milligrams per blister cavity per day (mg/cavity-day). These units may be used for both standard and referee testing. 1.10 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 ......

Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters

ASTM D7709-11e1 医药瓶和泡罩水蒸气透过率(WVTR)测定的标准试验方法

The purpose of these test methods is to obtain reliable values for WVTR that can be used to discriminate among barrier packages for pharmaceutical products. These test methods will establish a WVTR value that represents the water vapor transmission of the container closure system being evaluated. They are intended for use in evaluating or comparing, or both, the water vapor barrier performance of alternative packages for use in packaging of pharmaceutical products. While these methods were developed for a specific, limited application, they should be suitable for most types and sizes of consumer packages.1.1 The three test methods described herein are for measurement of water vapor transmission rates (WVTRs) of high-barrier multiple-unit containers (bottles), high-barrier single-unit containers (blisters), and quasi-barrier single-unit containers used for packaging pharmaceutical products. The containers are tested closed and sealed. These test methods can be used for all consumer-sized primary containers and bulk primary containers of a size limited only by the dimensions of the equipment and the weighing capacity and sensitivity of the balance. 1.2 These test methods are intended to be of sufficient sensitivity and precision to allow clear discrimination among the levels of barrier packages currently available for pharmaceutical products. 1.3 There are three methods: Method A is for bottles, Method B is for formed barrier blisters, and Method C is for formed quasi-barrier blisters. Methods B and C can be adapted for use with flexible pouches. 1.4 These test methods use gravimetric measurement to determine the rate of weight gain as a result of water vapor transmission into the package and subsequent uptake by a desiccant enclosed within the package. The packages are exposed to environments typical of those used for accelerated stability testing of drug products in the package (typically 40°C/75 % relative humidity [RH]). 1.5 For these methods, balance sensitivity, amount of desiccant, number of blisters per test unit, and weighing frequency were developed in an experiment based on Test Methods E96/E96M. 1.6 Test Methods E96/E96M gives specific instruction on the interactions among weighing frequency, number of data points necessary to establish steady state, minimum weight gain in a weighing period, and balance sensitivity. 1.7 The test methods in this standard were developed specifically for pharmaceutical bottles and blisters as closed container-closure systems. The experiment from which the methods were developed provided an inter-laboratory study from which the precision and bias statement was written. The packages in the study were small bottles and blisters used regularly for pharmaceutical solid oral dosage forms. 1.8 In spite of the specific nature of their application, the test methods in this standard should be suitable for other pharmaceutical packages and most types and sizes of other consumer packages. 1.9 The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. The units of measure for bottles are milligrams per bottle per day (mg/bottle-day) and for blisters, milligrams per blister cavity per day (mg/cavity-day). These units may be used for both standard and referee testing. 1.10 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 practice......

Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters

ASTM E2500-07 制药学和生物制药学制造设备的规范、设计和认证用标准指南

Application of the approach described within this guide is intended to satisfy international regulatory expectations in ensuring that manufacturing systems and equipment are fit for intended use, and to satisfy requirements for design, installation, operation, and performance. The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach. This guide supports, and is consistent with, the framework described in ICH Q8 and ICH Q9. This guide may be used independently or in conjunction with other proposed E55 standards to be published by ASTM International.1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety.1.2 For brevity, these are referred to throughout the rest of this guide as manufacturing systems.1.3 This guide may also be applied to laboratory, information, and medical device manufacturing systems.1.4 This guide is applicable to both new and existing manufacturing systems. The approach may be used for the implementation of changes to existing systems, and their continuous improvement during operation.1.5 This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement.This standard does not address employee health and safety, environmental, or other non-GxP regulations. 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.

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

ASTM E2500-07(2012) 药物和生物药品生产系统和设备的质量标准, 设计和确认标准指南

1.1 This guide is applicable to all elements of pharmaceutical and biopharmaceutical manufacturing systems including: facility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems that have the potential to affect product quality and patient safety. 1.2 For brevity, these are referred to throughout the rest of this guide as manufacturing systems. 1.3 This guide may also be applied to laboratory, information, and medical device manufacturing systems. 1.4 This guide is applicable to both new and existing manufacturing systems. The approach may be used for the implementation of changes to existing systems, and their continuous improvement during operation. 1.5 This guide is applicable throughout the life-cycle of the manufacturing system from concept to retirement. 1.6 This standard does not address employee health and safety, environmental, or other non-GxP regulations. 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.

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment

ASTM F2559-06 书写可灭菌可剥离袋规范的标准指南

Medical device peel pouches are universally used by the industry and produced by a myriad of suppliers. They may be constructed of many different materials including films, foils, paper, nonwovens such as Tyvek, and combinations thereof. However, even with the diversity of materials, there are still basic requirements that all pouches should exhibit. Above all, the pouches must contain and protect the device while maintaining sterility during all physical handling. Pouch requirements may be divided into two categories, initial pouch and material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements should be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated within each clause, where applicable. This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of a preformed peelable pouch. Appropriate test methods for compliance are also cited. Note 18212;All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F 2097. The specification and its requirements should be mutually agreed to by the supplier and purchaser of pouches. This helps ensure that pouches will comply to specified requirements.1.1 This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems.1.2 Pouch styles are categorized as chevron, header, and corner peel. These pouches are typically manufactured by heat sealing, or in some cases, by cohesive cold sealing. The sealing bond is intended to be peeled open to aseptically dispense the contents.1.3 Pouch materials may be either porous, nonporous, or any combination of the two.1.4 This guide addresses some critical printing requirements on the pouch.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.

Standard Guide for Writing a Specification for Sterilizable Peel Pouches

ASTM F2311-06 治疗上用皮肤代用品分类的标准指南

This guide is intended to provide the foundation of standards for clinical assessment, clinical performance, and preclinical assessment of substitutes for skin grafts. This guide is intended to aid accurate claims and labeling for the clinical utilities of substitutes for skin grafts in regulatory reviews. In this guide, “replacement” and “substitute” have different meanings, although they can be used synonymously in ordinary English. “Replacement” is used only as an adjective in the context of “skin replacement surgery,” which is defined in . “Substitute” is used only as a noun in the context of “skin substitute,” which is defined in 2.1.7.11.1.1 This guide defines terminology and provides a system of classification for products that can be substituted for human or animal skin grafts (or grafts of the dermal or epidermal component tissues of skin) in medical and surgical therapies. This guide is intended to include (or be expandable to) possible future tissue engineered skin technology that could provide novel or superior therapeutic properties to those of natural skin grafts.1.2 As much as possible, terminology is based on medical dictionary definitions.1.3 Substitutes for skin grafts are classified by clinical utility only; the classification is independent of the technology used to make a skin substitute, its components, or whether the sources of components include human or animal tissue or other biological or non-biological materials.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 requirements prior to use.

Standard Guide for Classification of Therapeutic Skin Substitutes

ASTM F2475-05 医疗器件包装材料的生物可兼容性评价的标准指南

The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around or on the human body, these devices must do no harm. Therefore, the packaging materials that come in contact with the medical device must also be evaluated and determined to be safe for use with the human body in that they have no negative impact on the physical, chemical or biological properties of the device. . This evaluation may include both a study of relevant experience with and actual testing of packaging materials. Such an evaluation may result in the conclusion that no testing is needed if the material has a demonstrable history of safe use in the specific role that is the same as that of the package under design.The medical device manufacturer determines the need for appropriate testing, with consideration of the device/package interactions, if any. The responsibility of the packaging supplier is typically limited to the performance of cytotoxicity testing.1.1 This guide provides information to determine the appropriate testing for biocompatibility of packaging materials used to contain a medical device.1.2 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 to determine the applicability of regulatory limitations prior to use.

Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

ASTM F2315-03 藻酸胶中活细胞或组织的固定或包围的标准指南

The main use is to immobilize, support, or suspend living cells or tissue in a matrix. The use of an encapsulation/immobilization system may protect cells or tissues from immune rejection. When immobilizing biological material in alginate gels, there are numerous parameters that must be controlled. This guide contains a list of these parameters and describes the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of an encapsulation system using alginate. This guide only covers single gelled beads, coated or not, and not double capsules or other constructs. The alginate gelation technology covered by this guide may allow the formulation of cells and tissues into biomedical devices for use as tissue engineered medical products or drug delivery devices. These products may be appropriate for implantation based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application.DESIG: F2315 03 ^TITLE: Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels ^SCOPE:1. Scope 1.1 This guide discusses information relevant to the immobilization or encapsulation of living cells or tissue in alginate gels. Immobilized or encapsulated cells are suitable for use in biomedical and pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs).1.2 This guide addresses key parameters relevant for successful immobilization and encapsulation in alginate gels.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 requirements prior to use.

Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels

ASTM F2347-03 生物医疗和组织工程医疗产品中使用的作为初始材料的透明质酸盐的表征和试验标准指南

This guide contains a listing of those characterization parameters that are directly related to the functionality of hyaluronan. This guide can be used as an aid in the selection and characterization of the appropriate hyaluronan for a particular application. This guide is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular hyaluronan. It may have use in the regulation of these devices by appropriate authorities. The hyaluronan covered by this guide may be gelled, cross-linked, extruded, or otherwise formulated into biomedical devices for use in tissue engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue engineered medical product or drug delivery application. To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These are: identity of hyaluronan, physical and chemical characterization and testing, impurities profile, and performance-related tests.1.1 This guide covers the evaluation of hyaluronan suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs).1.2 This guide addresses key parameters relevant to the characterization and purity of hyaluronan.1.3 As with any material, some characteristics of hyaluronan may be altered by processing techniques, such as cross-linking and sterilization, required for the production of a specific formulation or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy and are not addressed in this guide.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 requirements prior to use.

Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications

ASTM F2311-03 治疗上用皮肤代用品分类的标准指南

1.1 This guide defines terminology and provides a system of classification for products that can be substituted for human or animal skin grafts (or grafts of the dermal or epidermal component tissues of skin) in medical and surgical therapies. This guide is intended to include (or be expandable to) possible future tissue engineered skin technology that could provide novel or superior therapeutic properties to those of natural skin grafts.1.2 As much as possible, terminology is based on medical dictionary definitions.1.3 Substitutes for skin grafts are classified by clinical utility only; the classification is independent of the technology used to make a skin substitute, its components, or whether the sources of components include human or animal tissue or other biological or non-biological materials.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 requirements prior to use.

Standard Guide for Classification of Therapeutic Skin Substitutes