the World Health Organization (WHO) PrequalificationTeam-Inspection Services (PQT INS) raisedthe urgency for a revision of the WHO Good manufacturing practices forinvestigational pharmaceutical products for clinicaltrials in humans(1). The Fifty-fifth...
1967年世界卫生组织(the World Health Organization,WHO)在出版的《国际药典》(1967年版)附录中进行了收载,1969年第22届世界卫生大会WHO建议各成员国的药品生产采用GMP制度,以确保药品质量和参加“国际贸易药品质量签证体制” (Certificate-ion Scheme On the Quality Of Pharmaceutical Products Moving in International C...
the World Health Organization (WHO) PrequalificationTeam-Inspection Services (PQT INS) raisedthe urgency for a revision of the WHO Good manufacturing practices forinvestigational pharmaceutical products for clinicaltrials in humans(1). The Fifty-fifth...
2 The contents of a batch certificate for medicinal products are presented in Appendix II to this Annex. 1.5.2 In accordance with the principles described in Section 1.4 of this Annex, the QP certifying the finished medicinal product batch may take account of the confirmation by, and share ...
3.2 Although the focus is on medicinal (pharmaceutical) products, some of the principles may be applied to other investigational products. 尽管重点放在医药产品(药品)上,但某些原则可能适用于其他研究性产品。 4. Quality management 质量管理 4.1 There should be a comprehensively designed, clearly defined,...
3.1. The recommendations in this guidelineare applicable to investigational products for human and veterinary use. 本指南的建议适用于人用和兽用临床试验药品。 3.2. Although the focus is on medicinal(pharmaceutical) products, some of the principles may be applied to otherinvestigational products. ...
16. COS / CEP( Certificate of Suitability for European Pharmacopeia ):欧 洲药典适用性证书. 17. CCD (Certification Committee for Drugs):药品认证管理中心. 18. CPMP(Committee for Proprietary Medicinal Products): 欧洲专利药品委员会. 19. CTD(Common Technical Document):通用技术文件. 20. CDC( Centers...
2 The contents of a batch certificate for medicinal products are presented in Appendix II to this Annex. 1.5.2 In accordance with the principles described in Section 1.4 of this Annex, the QP certifying the finished medicinal product batch may take account of the confirmation by, and share ...
10、od Manufacturing Practices for pharmaceutical products. In: WHO ExpertCommittee on Specifications for Pharmaceutical Preparations. Twenty-secondreport. Geneva, World Health Organization, 1992 Annex 1 (WHO TechnicalReport Series, No. 823).2. Validation of analytical procedures used in the examination ...
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...