Good Trade and Distribution Practices for Pharmaceutical Starting Materials. WHO Technical Report Series, No. 996, 2016, Annex 6
(2016; 16 pages)

Resumen

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.

The WHO Expert Committee on Specifications for Pharmaceutical Preparations discussed the revision of the Good trade and distribution practices for pharmaceutical starting materials at several meetings. The scope of this WHO guidance on Good trade and distribution practices for pharmaceutical starting materials is applicable to any ingredient that is used in the manufacture of a medicinal product, including APIs, excipients and any others.

 
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