PIC/S Interprets Checklist For Auditing Drug GMP Inspectorates

11 Sep 2020

What makes a strong pharmaceutical inspectorate? It starts with some very specific legislative requirements that apply globally, inspectorate association explains.

Inspector removing a white card with Inspector sign from the inner pocket of his jacket. Conceptual of health, business or other inspection coming over unannounced. — the power of the inspector

The Pharmaceutical Inspection Cooperation Scheme recently published an interpretation guide for the common audit checklist used by PIC/S, the EU and Canada to assess regulatory authorities’ good manufacturing practices compliance programs.

PIC/S uses the checklist in qualifying regulatory authorities for membership. Health Canada uses it to evaluate authorities for mutual recognition...