C10 医药综合 标准查询与下载

KS B ISO 1:2014 动物性成分复合材料的一次性使用医疗器械的消毒.利用液体化学消毒剂进行消毒的常规控制和确认

Geometrical Product Specifications(GPS) — Standard reference temperature for geometrical product specification and verification

DIN SPEC 91315:2014 药物中等离子体源的一般要求

General requirements for plasma sources in medicine

ASTM E2326-14 查封药品分析员的教育和培训的标准实施规程

3.1 These are minimum standards applicable to those performing seized-drug analyses. 3.2 These standards are intended to apply to any laboratory analyst who: 3.2.1 Examines and analyzes seized drugs or related materials, or directs such examinations to be done; 3.2.2 Independently has access to unsealed evidence in order to remove samples from evidence for examination; and 3.2.3 As a consequence of such examinations, signs reports for court or investigative purposes. 1.1 This practice describes prerequisite formal education, training, and continuing professional development for those performing seized-drug analysis. It also describes the kinds of professional documents (for example, texts, manuals, or journals) that should be present in laboratories where analysis of seized drugs is conducted. 1.2 This practice does not replace knowledge, skill, ability, experience, education or training and should be used in conjunction with professional judgment. 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.

Standard Practice for Education and Training of Seized-Drug Analysts

ASTM E2474-14 使用过程分析技术进行制药工艺设计的标准实施规程

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), or 1.2.2 The outcome of this activity (the designed process), or both. 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. 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 Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

MH/T 7020-2013 民用航空人员体检鉴定诊断名称及编码

本标准规定了民用航空人员体检鉴定诊断名称及编码。本标准适用于民用航空人员体检鉴定。

Diagnosis name and code of physical examination and appraisal for civil aviation personnel

DIN EN ISO 22413:2013 药物制剂输送装置.试验方法和要求(ISO 22413-2010).德文版本EN ISO 22413-2013

Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010); German version EN ISO 22413:2013

DIN EN ISO 13408-1:2013 保健品无菌加工.第1部分:通用要求(ISO 13408-1-2008+Amd 1-2013).德文版本EN ISO 13408-1-2011+A1-2013

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008 + Amd 1:2013); German version EN ISO 13408-1:2011 + A1:2013

BS EN 1499:2013 化学消毒剂和防腐剂.符合卫生要求的手工清洗.试验方法和要求(第2阶段/第2步)

Chemical disinfectants and antiseptics. Hygienic handwash. Test method and requirements (phase 2/step 2)

BS EN 1500:2013 化学消毒剂和防腐剂.卫生学洗手方法.试验方法和要求(第2阶段/第2步)

Chemical disinfectants and antiseptics. Hygienic handrub. Test method and requirements (phase 2/step 2)

ISO 13408-1:2008/Amd 1:2013 保健品的无菌加工. 第1部分: 一般要求. 修改件1

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

BS EN ISO 22413:2013 药物制剂的转换装置.试验方法和要求

Transfer sets for pharmaceutical preparations. Requirements and test methods

ISO/TS 17665-3:2013 保健品灭菌.湿热.第3部分:蒸汽灭菌用医疗器械产品族和处理种类命名导则

Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization

JIS T 11140-1:2013 医疗保健产品灭菌.化学指示剂.第1部分:通用要求

Sterilization of health care products.Chemical indicators.Part 1: General requirements

ISO 13408-6:2006/Amd 1:2013 保健产品的无菌加工.第6部分:无菌隔离系统.修改件1

Aseptic processing of health care products - Part 6: Isolator systems; Amendment 1

BS ISO 13408-7:2012 保健产品的无菌加工.医疗器械和组合产品的替换加工

Aseptic processing of health care products. Alternative processes for medical devices and combination products

BS EN 12353:2013 化学消毒剂和防腐剂.杀菌剂(包括军团菌属 Legionella)、杀分枝杆菌剂、杀孢子剂、杀真菌剂和杀病毒剂(包括噬菌体)活性测定用试验菌的保存

Chemical disinfectants and antiseptics. Preservation of test organisms used for the determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal (including bacteriophages) activity

EN ISO 22413:2013 药物制剂转移装置.要求和试验方法

Diese Internationale Norm gilt fur sterilisierte, zur einmaligen Verwendung bestimmte Uberleitgerate fur pharmazeutische Zubereitungen.

Transfer sets for pharmaceutical preparations - Requirements and test methods

ANSI/NCPDP FBv 4.1-2013 NCPDP处方和福利标准v4.1-201x

NCPDP Formulary and Benefit Standard v4.1-201x

ANSI/NCPDP RDSv 2.0-2013 NCPDP退休人员药品补贴标准实施指南v2.0-201x

NCPDP Retiree Drug Subsidy Standard Implementation Guide v2.0-201x

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