制药用水2 May 09.pdfVIP

Pharmaceutical Water GMP Regulations Rules and Guidance (GMP) Rules Governing Medicinal Products in the European Community (Commission of the European Communities) Volume 4 - Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice Published in in Member Nations as local rules Code of Federal Regulations (CFR) Title 21 part 210 211 (Food and Drug Administration) WHO GMP for Pharmaceutical Water Module 1b- GMPs Slide 2 Pharmaceutical Water Systems © 2009 ISPE. All rights reserved. Page Enforcement Regulatory bodies legally enforce drug standards • Safety • Efficacy • Strength • Purity Module 1b- GMPs Slide 3 Enforcement (2) • Pharmacopoeias set drug standards but cannot enforce them • GMP Regulatory Agencies enforce drug standards but cannot set them • There are many grey areas open to interpretation by different regulators Module 1b- GMPs Slide 4 Pharmaceutical Water Systems © 2009 ISPE. All rights reserved. Page cGMP Requirements Module 1b- GMPs Slide 5 Good Manufacturing Practices If the manufacture or control procedures do not conform to cGMPs • Regulators may deem products to be