WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles. WHO Technical Report Series, No. 986, 2014, Annex 2
(2014; 59 pages)


During 2012 the Secretariat was made aware that the current Good manufacturing practices (GMP) for pharmaceutical products: main principles, published as Annex 3 in the WHO Technical Report Series, No. 961, 2011, would need updating. The WHO Expert Committee on Specifications for Pharmaceutical Preparations discussed the need for an update during its forty-seventh meeting and agreed to pursue the matter accordingly.

The following sections were updated in the newly revised version and, after the usual consultation process, were presented to the forty-eighth Expert Committee for adoption:

Section: Pharmaceutical quality system

Section 2: 2. Good manufacturing practices for pharmaceutical products

Section 7: Contract production, analysis and other activities

Section 17: 17. Good practices in quality control

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