美国的cGMP对所有的取样方法、检验步骤和方法、方法验证、检验不合格(OOS)评估处理等都规定得非常详尽,并有具体的指导文件(Investigating Out-of-SpecificationTestfor Pharmaceutical Production),从而最大程度上避免了药品在取样、检验环节上的偏差,为保证药品质量提供了保障。 八、对人员要求不同 我国GMP对人员的任职...
第一个阶段,以2006年美国FDA颁布《Guidance for Industry Quality Systems Approach toPharmaceutical CGMP Regulations》为代表,截止目前世界公认的GMP体系概念依然采用该指南的六大体系,下图的体系圆球已经深入人心。包括后面陆续完善的质量管理概念和工具,GMP的主体结构已经搭建完毕,质量体系中文件管理、偏差&OOS管理,CAPA管...
For more information about proper handling of OOS results and documenting your investigations, refer to the FDA guidance for industry Investigating OOS Test Results for Pharmaceutical Production at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf 关于如何...
Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 WHO药品GMP:主要原则 Introduction引言 General considerations总则 Glossary术语 Quality management in the medicines industry: philosophy and essential elements 制药企业的质量管理:GMP 理念和基本元素 1. Pharmaceutical quality...
No. The CGMP regulations neither approve nor prohibit specific equipment for use in manufacturing of pharmaceutical products (with the exception of asbestos and fiber-releasing filters, see 21 CFR 211.72).? We do not maintain a list of appr...
美国没有制定专门的原料药GMP,原料药检查主要依据制剂GMP与ICHQ7(GuidanceforIndustryQ7AGoodManufacturingPracticeGuidanceforActivePharmaceuticalIngredients)。FDA还根据需要及时对GMP进行修订,强调其动态或现行(Current),所以又称为cGMP(CurrentGoodManufacturingPractice)。
第一个阶段,以2006年美国FDA颁布《Guidance for Industry Quality Systems Approach toPharmaceutical CGMP Regulations》为代表,截止目前世界公认的GMP体系概念依然采用该指南的六大体系,下图的体系圆球已经深入人心。包括后面陆续完善的质量管理概念和工具,GMP的主体结构已经搭建完毕,质量体系中文件管理、偏差&OOS管理,CAPA管...
(e.g., containers) from contamination. The air speed range of 0.36 - 0.54 m/s is, as stated in the above paragraph itself, merely a guideline value that has been encountered in the pharmaceutical industry for decades. Annex 1, however, clearly allows for the establishment of alternative ...
The Good Manufacturing Practice (GMP) is a set of guidelines that ensure the quality and safety of pharmaceutical products.In China, the GMP regulations are crucial for the pharmaceutical industry to maintain international standards.This document provides an English translation of the appendices to the...