Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.

Good Manufacturing Practices (GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practice') is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.

2014年10月1日 · This guide to GMP shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities.

2003年10月8日 · Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.

2022年10月31日 · This document is a revision of WHO good manufacturing practices for sterile pharmaceutical products, previously published in the WHO Technical Report Series, No. 961, Annex 6, 2011.1 The revision was done in collaboration with the European Union and the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

The European Medicines Agency's (EMA) provides answers to frequently asked questions on good manufacturing practice (GMP) and good distribution practice (GDP), as discussed and agreed by the GMP/GDP Inspectors Working Group.

Good Manufacturing Practices (GMP) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification. The first WHO draft text on GMP was adopted in 1968.

The Guide presents a review of the types and extent of validations required by GMP, the preparation of a Master Validation Plan, formats for the equipment and systems qualifications and process and analytical assay validation protocols, and examples of

nd introducing the concept of a “quality unit”. During 2012 the Secretariat was made aware that the current Good manufacturing practices (GMP) for pharmaceutical products: main principles, published as Annex 3 in the WHO Technical Report Series, No. 961, 2011, would need updating (http://www.who.int/medicines/areas/quality_safety/quality_ assur...

2014年1月1日 · 欧盟GMP中强调的要求与WHO GMP相似，而中国新版GMP于2011年正式生效，两者既有相似之处，也存在一定差异。 本文将介绍并对比这两版GMP法规，以向制药企业阐述二者的区别。 欧盟GMP概述 EudraLex是欧盟药品法规集锦，共有10部。 本集锦的第4部专门收集了欧盟有关药品管理的法规，其中包括对人药和兽药药品生产质量管理规范的解释。 第4部共包括3个部分、19个附录和术语解释。 欧盟GMP 第一部分为对药品的基本要求，包括9个章节：质 …