PIC/S Implements EU Risk-Management GMPs
A global regulatory group is following the EU’s lead in recommending that drugmakers use a risk-management approach to qualify and validate manufacturing processes.
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, or PIC/S, has adopted the European Commission’s GMP Annex 15, meaning retrospective validation will no longer be accepted. Risk management should be used to assess planned manufacturing changes to determine their impact on quality, documentation, validation, regulatory status, calibration and maintenance to avoid unintended consequences, the guideline says.
The revisions — which draw on ICH Q8, Q9 and Q10 — reflect changes in manufacturing and drug regulation that have occurred since 2001.
PIC/S consists of 46 participating regulatory authorities worldwide, including the 28 EU member states. Both the EU and PIC/S guidelines take effect Oct. 1.
Read PIC/S’ Annex 15 at www.fdanews.com/04-20-15-PICSannex.pdf. — Kellen Owings