WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce: Questions and Answers (Q & A). Adopted guidance. (WHO Drug Information Vol. 30, No. 3, 2016)
(2016; 13 pages)


The WHO Certification Scheme for finished pharmaceutical products is an international voluntary agreement to provide assurance to countries participating in the Scheme, about the quality of pharmaceutical products moving in international commerce.

This is a revision of a WHO guidance document as adopted by the Expert Committee for Specifications on Pharmaceutical Preparations at its 50 the Meeting held in October 2015. The meeting report is available at www.who.int/entity/medicines/publications/ pharmprep/trs_996/en/index.html. Prior to its adoption the text was posted for public comment on the WHO web site as Working Document QAS/15.623, June 2016. WHO guidance related to the Certification Scheme is available at www.who.int/medicines/ areas/quality_safety/regulation_legislation/certification

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