Good trade and distribution practices for starting materials

Good trade and distribution practices for pharmaceutical starting materials (revision) - Annex 6

Good trade and distribution practices for pharmaceutical starting materials (revision) - Annex 6

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TABLE OF CONTENTS


Introduction 

1. Quality management 

2. Organization and personnel 

3. Premises 

4. Procurement, warehousing and storage 

5. Equipment 

6. Documentation 

7. Repackaging and relabeling 

8. Complaints 

9. Recalls 

10. Returned goods 

11. Handling of non-conforming materials 

12. Dispatch and transport 

13. Contract activities 

References 


Introduction

Good manufacturing practices for active pharmaceutical ingredients were published in 2000 by The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), in ICH Q7 (1). Section 17 of this ICH text includes guidelines for agents, brokers, traders, distributors, repackers and relabellers. This section was written based on the outcome of the World Health Organization (WHO) investigation into deaths resulting from the intentional relabeling of industrial grade ethylene glycol as pharmaceutical grade material. This material was subsequently formulated into a paediatric medicine that caused many deaths. Section 17 of this good manufacturing practice (GMP) guide for active pharmaceutical ingredients (APIs) applies to any party other than the original manufacturer which may trade and/or take possession, repack, relabel, manipulate, distribute or store an API or API intermediate. The scope of ICH Q7 does not include excipients.

Following a number of incidents involving diethylene glycol and a World Health Assembly resolution (WHA52.19), WHO published the Good trade and distribution practices for pharmaceutical starting materials in 2004 (2). At the time of publication of these guidelines, WHO had not yet adopted the text from ICH Q7 as GMP for APIs. The WHO guidance for excipients (3), published in 1999, did not cover trade and distribution practices for excipients.

In 2010, WHO published Good manufacturing practices for active pharmaceutical ingredients (4), which reflect the text from ICH Q7 and include Section 17 of that document, to replace the existing WHO GMP for APIs.


Good trade and distribution practices for pharmaceutical starting materials (revision) - Annex 6

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