as an annex to its twenty-second report. The text was then reproduced(with some revisions) in 1971 in the Supplement to the second editionof
The International Pharmacopoeia
.In 1969, when the World Health Assembly recommended the
rstversion of the WHO Certi
cation Scheme on the Quality of Pharma-ceutical Products Moving in International Commerce in resolutionWHA22.50, it accepted at the same time the GMP text as an integralpart of the Scheme. Revised versions of both the Certi
cation Schemeand the GMP text were adopted in 1975 by resolution WHA28.65.Since then, the Certi
cation Scheme has been extended to include thecerti
veterinary products administered to food-producing animals;
starting materials for use in dosage forms, when they are subject tocontrol by legislation in both the exporting Member State and theimporting Member State;
information on safety and ef
cacy (resolution WHA41.18, 1988).In 1992, the revised draft requirements for GMP were presented inthree parts, of which only Parts One and Two are reproduced in thisdocument (
Quality management in the drug industry: philosophy and essentialelements
, outlines the general concepts of quality assurance as wellas the principal components or subsystems of GMP, which are jointresponsibilities of top management and of production and qualitycontrol management. These include hygiene, validation, self-inspec-tion, personnel, premises, equipment, materials and documentation.
Good practices in production and quality control
, provides guid-ance on actions to be taken separately by production and by qualitycontrol personnel for the implementation of the general principles of quality assurance.These two parts were subsequently supplemented by further guide-lines which are integral parts of these good manufacturing practicesfor pharmaceutical products. All these texts are available on theweb page of the World Health Organization. (http.www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpcover.html)Considerable developments in GMP have taken place in the interven-ing years, and important national and international documents, in-cluding new revisions, have appeared (
). Thus the necessity torevise the main principles and incorporate the concept of validation.