WHO Good Manufacturing Practices for Pharmaceutical Products: Main Principles. WHO Technical Report Series, No. 961, 2011, Annex 3
(2011; 54 pages)

In 1992, the revised draft requirements for GMP were presented in three parts, of which only Parts One and Two are reproduced in this document. “Quality management in the medicines industry: philosophy and essential elements”, outlines the general concepts of quality assurance (QA) as well as the principal components or subsystems of GMP, which are joint responsibilities of top management and of production and quality control management. These include hygiene, validation, self-inspection, personnel, premises, equipment, materials and documentation.

“Good practices in production and quality control”, provides guidance on actions to be taken separately by production and by quality control personnel for the implementation of the general principles of QA.

These two parts were subsequently supplemented by further guidelines which are integral parts of these GMP for pharmaceutical products. All these texts are available on the Medicines web page http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html. Considerable developments in GMP have taken place in the intervening years, and important national and international documents, including new revisions, have appeared. Thus the necessity to revise the main principles and incorporate the concept of validation...

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