PIC/S Classification System for Sterile Products
Pharmaceutical Inspection Convention/Co-operation Scheme Guidelines for Manufacturing of Sterile Medicinal Products
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international organization between pharmaceutical inspection authorities that aims to harmonize Good Manufacturing Practice (GMP) standards and promote mutual recognition of inspections. PIC/S develops and maintains the "Guide to Good Manufacturing Practice for Medicinal Products," with Annex 1 specifically addressing the manufacture of sterile medicinal products.
PIC/S Annex 1 has evolved significantly since its initial development. Key milestones include:
- 1971: First EU GMP Guide published
- 1989: First version of Annex 1 specifically for sterile products
- 2003: Major revision incorporating risk-based approaches and new technologies
- 2008: Revision emphasizing contamination control strategy and quality risk management
- 2020: Major revision draft released for public consultation
- 2022: New version adopted with significant changes to cleanroom classification and monitoring
PIC/S Annex 1 defines four grades of clean areas (A, B, C, and D) for manufacturing sterile products. These grades are based on maximum permitted particle counts in both "at rest" and "in operation" states, as well as microbial limits.
| Grade | Maximum permitted number of particles/m³ equal to or greater than the tabulated size | Microbial limits (CFU) | ||
|---|---|---|---|---|
| At Rest | In Operation | Corresponding ISO Class | ||
| A | 3,520 (0.5μm) 20 (5.0μm) |
3,520 (0.5μm) 20 (5.0μm) |
ISO 5 |
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