Thursday 22 October 2015

Revision of PIC/S GMP Guide

The PIC/S GMP Guide (PE 009-12) has been revised to incorporate revised Annex 15. It will entered into force on 1st October 2015.

The guide states:

“In order to further facilitate the removal of barriers to trade in medicinal products, to promote uniformity in licensing decisions and to ensure the maintaining of high standards of quality assurance in the development, manufacture and control of medicinal products, the following Guide to Good Manufacturing Practice for Medicinal Products and its Annexes has been adopted.

The standards set out herein apply to medicines and similar products intended for human use. It is recommended, however, that the same kind of attention be given to the manufacture of veterinary products. Administrative measures of national health authorities should be directed towards the application of these standards in practice, and any new or amended national regulations for good manufacturing practice should at least meet their level. These standards are also intended to serve manufacturers as a basis for the elaboration of specific rules adapted to their individual needs.”

For details see PIC/S

 Posted by Tim Sandle

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