Pharmaceutical Inspection Co-operation Scheme standards and certification for Pakistan's pharma industry.
PIC/S includes 52 regulatory authorities across the globe
PIC/S certification recognized in EU, Australia, Canada, and more
DRAP is working toward full PIC/S membership for Pakistan
PIC/S GMP guides are harmonized with EU and WHO GMP
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international cooperative arrangement among regulatory authorities aiming to harmonize GMP standards globally. PIC/S membership means a country's regulatory authority adheres to internationally recognized GMP guidelines and cooperates on inspection activities with other member authorities.
A GMP certificate issued by a PIC/S member authority is recognized across 52+ jurisdictions, significantly reducing the need for re-inspection. For Pakistani manufacturers, working toward PIC/S-compliant GMP systems (even before DRAP achieves full membership) demonstrates commitment to quality and simplifies market access in Australia (TGA), UK (MHRA), Canada (Health Canada), and EU member states.
DRAP has been engaging with PIC/S secretariat as an observer. Implementation of PIC/S PE 009 GMP Guide across Pakistani manufacturing facilities, combined with capacity-building inspectorate training at DRAP, is a prerequisite for observer status and eventual membership. This progression will significantly enhance the international credibility of Pakistan's pharmaceutical exports.