PIC/S Annex 15 Revision

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] PIC/S has announced that it has adopted, by procedure, the EU Annex 15 revision (see IPQ “Monthly Update” Jan./Feb. 2013, pp. 24-30). Annex 15 describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products from a GMP vantage point, and may also be used as supplementary optional guidance for active substances. The annex was approved by the EU in March and will go into effect on October 1.
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