8/9 June 2021
Mid of April the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has taken over the revised Annex 15 of the EU GMP Guide on Validation and Qualification in their GMP Guide. We reported about the Annex 15 revision in detail. The Annex 15 takeover by PIC/S was expected, but is yet interesting as now the new requirements with regard to validation and qualification will also be applicable in non-EU countries - for instance in Canada, Australia, Taiwan and Argentina.
Similar to the EU Annex 15 the document becomes effective on 1 October 2015.
Please see the PIC/S website for the Guide to Good Manufacturing Practice for Medicinal Products - Annex 15.