Pharma Production Brochure - EMD Chemicals

References
European Community EC Guide to Good Manufactureing Practice for Medicinal Products for Human and
Veterinary Use
EFCG Position Paper: Excipients used in Pharmaceutical Manufacturing September 2007
European Union Commission DIRECTIVE 2004/27/EC OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 31 March 2004 amending Directive 2001/83/EC on the Community code
relating to medicinal products for human use
FDA Code of Federal Regulation title 21 part 210 and 211 (April 2008)
FDA Code of Federal Regulation title 21 part 11 Electronic Records, Electronic Signatures,
Final rule (March 2000)
FDA Guideline on General Principles of Process Validation (Feb . 1993)
FDA/DHSS Draft Guidance for Industry on Manufacturing, Processing or Holding APIs
(Mar . 1998)
ICH Note for Guidance on Good Manufacturing Practices for Pharmaceutical Ingredients
Q7 (August 2001)
ICH Test procedures and acceptance criteria for new drug substances and new drug
products Q6A (Oct . 1999)
ICH Q3A (R2): Impurities in New Drug Substances (Revised Guideline) (Oct . 2006)
IPEC-PQG The Joint IPEC-PQG Good Distribution Practices Guide for Pharmaceutical Excipients
(2006)
IPEC-PQG The Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical
Excipients (2006)
ISO Quality Management Systems-Requirements, ISO 9001:2000 (Dec . 2000)
PIC/S PIC/S GMP GUIDE (May 2007)
WHO Good Manufacturing Practices for Pharmaceutical Products . In: WHO Expert
Committee on Specifications for Pharmaceutical Preparations 37th Report, Geneva,
World Health Organisation, 2003, Annex 4, WHO Technical Report Series No . 908)
WHO Good Manufacturing Practices for Pharmaceutical Products . In: WHO Expert
Committee on Specifications for Pharmaceutical Preparations 38th Report, Geneva,
World Health Organisation, 2004, Annex 2, WHO Technical Report Series No . 917
WHO GMP Supplementary Guidelines for the Manufacture of Pharmaceutical Excipients;
WHO Technical Report Series, No . 885, (1999)
WHO Good Trade and Distribution Practises for Pharmaceutical Starting Materials, World
Health Organization, WHO Technical Report Series, No . 917, 2003
EMD for Pharmaceutical Production · www .emdchemicals .com
21