Appendix
Guidance documents related to good manufacturing and distribution practices (GMP, GDP) of pharmaceutical starting materials
1. CEFIC, Guidelines for Handling and Distribution of Propylene Glycol USP/EP (1999), Revision 1 in 2003, Revision 1.1. in
2006, Revision 2 under development. Industry code of best practice guidelines, created by the European manufacturers of propylene
glycol.
2. CEFIC and FECC (European Association of Chemical Distributors), European Single Assessment Document for Chemical Distributors
(ESAD), Appendix B for Food, Pharma and/or Cosmetic Products (1999), Revised in 2003 and 2006 (SQAS-Distributor, Appendix
F and subsection G for pharmaceutical excipients added in latest revision). Third party assessment scheme with questionnaires
and guidance document.
3. WHO Expert Committee on Specifications for Pharmaceutical Preparations, Good Manufacturing Practices—Supplementary Guidelines
for the Manufacture of Pharmaceutical Excipients, Annex 5, WHO Technical Report Series, No. 885 (Geneva, 1999).
4. ICH, Q7: Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients (Geneva, 2000). Chapter 17 defines specific
requirements for distributors of APIs. This globally harmonized document has been overtaken in European legislation as GMP
Annex 18 (2001), and published as Part II of the European Union's Guidelines to Good Manufacturing Practice Medicinal Products
for Human and Veterinary Use—Basic Requirements for Active Substances used as Starting Materials (2005).
5. IPEC, Good Manufacturing Practices Audit Guideline for Distributors of Bulk Pharmaceutical Excipients and guidance for
excipient distributors IS THIS THE ACCURATE TITLE?, based on IPEC's 1997 Good Manufacturing Practices Guide for Bulk Pharmaceutical
Excipients (2000). This guideline has been replaced by the organization's GDP 2008 audit guide.
6. WHO Expert Committee on Specifications for Pharmaceutical Preparations, Good Trade and Distribution Practices for Pharmaceutical
Starting Materials, WHO Technical Report Series, No. 917 (Geneva, 2003). This document provides general principles of good
practices in the supply chain of pharmaceutical starting materials (APIs and excipients),
7. IPEC, Joint IPEC-PQG Good Manufacturing Practice Guide for Pharmaceutical Excipients (2006). The second revision of this
comprehensive guide was first published in 1995, revised 2001 to align with ISO 9001:2000, and revised again in 2006 as a
joint venture with the Pharmaceutical Quality Group.
8. IPEC, IPEC Good Distribution Practices Guide for Pharmaceutical Excipients (2006). Explanatory document to WHO's GTDP
guideline, providing detailed "how to" guidance for supply chain operations of excipients.
9. IPEC, IPEC Good Distribution Practices Audit Guideline for Pharmaceutical Excipients (2008). GDP audit guide based on the
SQAS-Distributor (ESAD II) assessment scheme, with additional questionnaire questions.
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