Inside IPEC: Good Distribution Practices for Pharmaceutical Excipients - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Inside IPEC: Good Distribution Practices for Pharmaceutical Excipients
The GDP committee of IPEC–Europe is trying to seal one more broken link in the supply chain. This article contains bonus online-exclusive material.

Pharmaceutical Technology
Volume 33, Issue 5


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 This guideline has been replaced by the organization's GDP 2008 audit guide.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.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here