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GMP Guidelines

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cGMP guidelines

International standards control the quality and safety of drugs and the substances used in their manufacture.

These rules and regulations, generally known as cGMP Guidelines, are valid throughout the world and are expected to be ultimately codified into a global standard. In addition to established cGMP guidelines for the manufacture of active substances, discussions are currently underway on corresponding regulations for excipients. At Merck KGaA, Darmstadt, Germany, we participate actively in these policy forming discussions around the world.

GMP Guidelines
All products at EMD, which are determined for human use are treated under GMP aspects.
Merck KGaA, Darmstadt, Germany
  • Audits its suppliers.
  • Operates a quality assurance system.
  • Produces numerous active ingredients and excipients according to cGMP.
  • Analyzes its products using a validated cGMP-conform system.
  • Effects transport using cGMP-tested forwarding companies.
  • Afrees to change-control-processes with its customers.
  • Compiles comprehensive product documentation.

BMG Betriebsverordnung für die Herstellung von Wirkstoffen für Arzneimittel (WirkstoffBetr.V) German draft (Oct. 1994)
CEFIC Guidelines for Handling and Distribution of Propylene Glycol USP/Ph.Eur., Propylene Oxide/Propylene Glycols Sector Group of CEFIC (1999)
CEFIC/EFPIA GMP for Active Ingredients Manufacturers (Aug. 1996)
DEFIC/FECC European Single Assessment Document for Chemical Distributors (ESAD), Published by DEFIC and FECC (Jan. 1999)
EU GL 75/319 (Feb. 1999)
FDA Code of Federal Regulation title 21 part 210 and 211 (Sept. 2001)
FDA Code of Federal Regulation title 21 part 11 Electronic Records, Electronic Signatur, Final rule (March 1997)
FDA Guideline on General Principles of Process Validation (Feb. 1993)
FDA/DHSS Draft Guidance for Industry on Manufacturing, Processing or Holding APIs (March 1998)
FECC/VCH/VDC GMP Guide for APIs, Distributors and Traders (Oct. 1998)
ICH Guideline on GMP for APIs (Q7A, July 2001)
ICH Test procedures and acceptance criteria for new drug substances and new drug products (Oct. 1999)
ICH Impurities in new drug substances (Oct. 1999)
ICH Note for Guidance on GMP for API (Nov. 2000)
IPEC Audit Guide for Distributors of Bulk Pharmaceutical Excipients (April 2000, currently under revision)
IPEC GMP Guide for Bulk Pharmaceutical Excipients (Dec. 2001)
ISO 9001 Quality Management System, Requirements (Dec. 2000)
ISPE Baseline Pharm. Engineer. Guides, Bulk Ph. Chem. (June 1996)
PhRMA Guide for Production, Packaging, Repackaging or Holding of Medicinal Substances (Sept. 1995)
PIC/S API Guide (Feb. 1987)
PIC/S API Guide (4. Draft, Apr. 1997)
WHO GMP for Pharmaceutical Products of the World Health Organization, WHOTechnical Report Series, No. 823, 32nd Report, Geneva (1992)
WHO, FDA, CDC The Diethylene Glycol Contamination Prevention Workshop (Feb. 20-21, 1997), Washington, D.C.
WHO GMP Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients; WHO Technical Report Series, No. 885 (1999)