PIC/S GMP

What PIC/S Is

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a cooperative arrangement between more than 50 national regulatory authorities worldwide, including Thailand’s FDA (a member since 2016), working to harmonize Good Manufacturing Practice (GMP) inspection standards for pharmaceutical facilities.

Core GMP Principles Under PIC/S

Covers quality control across the entire production process — facility and environmental design, raw material control, manufacturing processes, quality testing, and traceable documentation.

What Inspections Cover

PIC/S GMP inspections assess facility structure (e.g. cleanroom classifications), supporting utilities (HVAC, purified water), manufacturing and packaging processes, and the organization’s quality management system.

Why It Matters to Manufacturers

Facilities certified to PIC/S GMP standards can more easily export to other member countries, since the standard is mutually recognized, reducing duplicate inspections across jurisdictions.