C10 医药综合 标准查询与下载

ANSI/NCPDP SC2013071-2013 NCPDP脚本标准2013071

NCPDP SCRIPT Standard 2013071

ANSI/AAMI/ISO 13408-1/A1:2013 保健产品的无菌加工.第1部分:通用要求.修改件1

Aseptic processing of health care products - Part 1: General requirements - Amendment 1

ASTM E2891-13 制药开发和生产应用中多变量数据分析的标准指南

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). 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 no......

Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

BS EN 13727:2012+A1:2013 化学消毒剂和防腐剂. 用于评估医学领域杀菌活性的定量悬浮试验. 试验方法和要求 (第2阶段, 第1步)

Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity in the medical area. Test method and requirements (phase 2, step 1)

KS P 1015-2012 心血管疾病的检测方法肌钙蛋白诊断标准物质的标准和评估方法

이 표준은 트로포닌의 탐지를 통해 협심증 또는 심근경색 등의 심혈관질환을 진단하기 위해 의

Establishment of a reference material and evaluation method for troponin-based cardiovascular diagnostics

KS P 3000-2012 中医药.艾灸的通用要求事项

이 표준은 의료용으로 사용하는 뜸의 종류, 뜸을 뜨는 데 사용되는 재료 및 뜸을 뜨는 데

General requirement of moxibustion in oriental medicine

ANSI/NCPDP SC2012011-2012 NCPDP SCRIPT标准201xxx

NCPDP SCRIPT Standard 201xxx

ANSI/NCPDP SC2012031-2012 NCPDP脚本标准2012031

NCPDP SCRIPT Standard 2012031

ASTM D7709-12(2017) 测量药瓶和水泡包装水蒸气透过性(WVTR)的标准试验方法

5.1 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. 5.2 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 408201;°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 ......

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

BS EN ISO 13408-5:2011 保健品的无菌加工.适当消毒

Aseptic processing of health care products. Sterilization in place

BS EN ISO 13408-4:2011 保健品的无菌加工.现场清洁技术

Aseptic processing of health care products. Clean-in-place technologies

BS EN ISO 13408-2:2011 保健品的无菌加工.过滤

Aseptic processing of health care products. Filtration

BS EN ISO 13408-3:2011 保健品的无菌加工.冷冻干燥

Aseptic processing of health care products. Lyophilization

BS EN ISO 13408-1:2011+A1:2013 保健品的无菌加工.通用要求

Aseptic processing of health care products. General requirements

BS EN ISO 13408-6:2011+A1:2013 保健品的无菌加工.隔音系统

Aseptic processing of health care products. Isolator systems

BS EN ISO 13408-6:2011 保健品的无菌加工.隔音系统

Aseptic processing of health care products. Isolator systems

BS EN ISO 14160:2011 医疗保健产品的无菌加工.动物组织及其衍生产品制单次使用医疗器械用液体化学消毒剂.医疗器械灭菌工艺的特性描述,开发,确认和常规控制要求

This International Standard specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin. This International Standard covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see Note 1). This International Standard is not applicable to material of human origin. This International Standard does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see Note 2). This International Standard does not describe methods for validation of the inactivation or elimination of protozoa and parasites. The requirements for validation and routine control described in this International Standard are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see Note 4). This International Standard does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see Note 5). This International Standard does not cover the level of residual sterilizing agent within medical devices (see Note 6). This International Standard does not describe a quality management system for the control of all stages of manufacture (see Note 7). NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1, is important. NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this International Standard does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2. NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3. NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a defined sterilization process. NOTE 5 Such testing is a crucial part of the design and development of a medical device. NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents. NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.

Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization proc

ASTM F2315-11 藻酸盐凝胶体中活性细胞或组织的固定或封装的标准指南

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.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. 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 requirements prior to use.

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

ASTM F2743-11 涂料药物洗脱血管支架系统检查和急性颗粒表征的标准指南

The shedding of the coating from a vascular stent can alter its clinical safety and/or therapeutic benefit. Clinical performance (for example, drug elution) may be affected by particulate generation from the coated stent system and coating defects. This document provides guidance for coating inspection and acute particulate characterization of drug eluting vascular stents. Information about the potential for shedding can be gained during bench testing. The general guidelines presented here may be used for writing detailed protocols for specific products at the various stages of the product development process. Such testing may be performed during device development, design validation testing, lot-release testing, and/or stability testing although different requirements may apply at each stage. These suggested methods may represent a reasonable simulation of clinical usage. When establishing the coating inspection and acute particulate characterization testing conditions, the current clinical usage/practice (for example, post-dilation, overlapping stents) and the instructions for use (IFU), as applicable, should be considered. While methods for chronic particulate characterization and coating inspection have not been established, these suggested methods may be helpful in the development of chronic methods. Testing in accordance with recommendations in this guide will generate data that may lead to further improvements in the method and its validation, as well as possible advancements in device design and performance. See also FDA Guidance for Industry and FDA Staff and AAMI TIR42:2010.1.1 This guide describes recommended in vitro test procedures for coating inspection and acute particulate characterization of coated drug-eluting vascular (balloon-expandable and self-expanding) stent systems. 1.2 Recommended practices for coating inspection and acute particulate characterization include baseline (deployment) testing and simulated use testing. This guide describes the capture and analysis of particulates. This guide describes the inspection of the coated stent surface. This guide was developed for characterization and not intended for production release testing of coated drug-eluting vascular stent systems although some sections may be appropriate. 1.3 Chronic particulate characterization and coating inspection are not included herein. 1.4 Coating systems specifically designed to degrade or otherwise intentionally separate themselves from the permanent stent structure may not be fully addressed herein. 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 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.

Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems

ASTM E2839-11 生产抗菌生物制剂效能评估所用梭状芽胞杆菌的标准试验方法

This test method describes a procedure for preparing a spore suspension of C. difficile strain ATCC 43598 that meets specific criteria necessary for efficacy testing of antimicrobials designed to eliminate C. difficile contamination from environmental surfaces. The acceptability criteria for the spore suspension are: (1) a viability titer of >8 log10/mL, (2) purity of ≥95 %, and (3) that spores be resistant to 10 min of exposure to 2.5 M HCl. 1.1 This test method is for producing C. difficile spores to evaluate antimicrobial formulations for their sporicidal activity. 1.2 It is the responsibility of the investigator to determine whether Good Laboratory Practices (GLP) are required and to follow them when appropriate. 1.3 This standard may involve hazardous materials, chemicals, and microorganisms and should be performed only by persons with formal training in microbiology. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Production of Clostridium difficile Spores for Use in Efficacy Evaluation of Antimicrobial Agents