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GMP Guidelines


BMGBetriebsverordnung für die Herstellung von Wirkstoffen für Arzneimittel (WirkstoffBetr.V) German draft (Oct. 1994)
CEFICGuidelines for Handling and Distribution of Propylene Glycol USP/Ph.Eur., Propylene Oxide/Propylene Glycols Sector Group of CEFIC (1999)
CEFIC/EFPIAGMP for Active Ingredients Manufacturers (Aug. 1996)
DEFIC/FECCEuropean Single Assessment Document for Chemical Distributors (ESAD), Published by DEFIC and FECC (Jan. 1999)
EU GL75/319 (Feb. 1999)
FDACode of Federal Regulation title 21 part 210 and 211 (Sept. 2001)
FDACode of Federal Regulation title 21 part 11 Electronic Records, Electronic Signatur, Final rule (March 1997)
FDAGuideline on General Principles of Process Validation (Feb. 1993)
FDA/DHSSDraft Guidance for Industry on Manufacturing, Processing or Holding APIs (March 1998)
FECC/VCH/VDCGMP Guide for APIs, Distributors and Traders (Oct. 1998)
ICHGuideline on GMP for APIs (Q7A, July 2001)
ICHTest procedures and acceptance criteria for new drug substances and new drug products (Oct. 1999)
ICHImpurities in new drug substances (Oct. 1999)
ICHNote for Guidance on GMP for API (Nov. 2000)
IPECAudit Guide for Distributors of Bulk Pharmaceutical Excipients (April 2000, currently under revision)
IPECGMP Guide for Bulk Pharmaceutical Excipients (Dec. 2001)
ISO 9001Quality Management System, Requirements (Dec. 2000)
ISPEBaseline Pharm. Engineer. Guides, Bulk Ph. Chem. (June 1996)
PhRMAGuide for Production, Packaging, Repackaging or Holding of Medicinal Substances (Sept. 1995)
PIC/S APIGuide (Feb. 1987)
PIC/S APIGuide (4. Draft, Apr. 1997)
WHOGMP for Pharmaceutical Products of the World Health Organization, WHOTechnical Report Series, No. 823, 32nd Report, Geneva (1992)
WHO, FDA, CDCThe Diethylene Glycol Contamination Prevention Workshop (Feb. 20-21, 1997), Washington, D.C.
WHOGMP Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients; WHO Technical Report Series, No. 885 (1999)

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