PIC/S: GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEXES
Annex 1: Manufacture of sterile medicinal products
Annex 2A: Manufacture of advanced therapy medicinal products for human use
Annex 2B: Manufacture of biological medicinal substances and products for human use
Annex 3: Manufacture of radiopharmaceuticals
Annex 4: Manufacture of veterinary medicinal products other than immunologicals
Annex 5: Manufacture of immunological veterinary medical products
Annex 6: Manufacture of medicinal gases
Annex 7: Manufacture of herbal medicinal products
Annex 8: Sampling of starting and packaging material’s
Annex 9: Manufacture of liquids, creams and ointments
Annex 10: Manufacture of pressurized metered dose
Annex 11: Computerized systems
Annex 12: Use of ionizing radiation in the manufacture of medicinal products
Annex 13: Manufacture of investigational medicinal products
Annex 14: Manufacture of medicinal products derived from human blood or plasma
Annex 15: Qualification and validation
Annex 16: Authorized person and batch release
Annex 17: Real Time Release Testing and Parametric Release
Annex 18: GMP Guide for active pharmaceutical ingredients**
Annex 19: Reference and retention samples
Annex 20: Quality risk management
Appendix I: Risk Management Methods and Tools
Appendix II: Potential Applications For Quality Risk Management
The EU first adopted the ICH GMP Guide on APIs as Annex 18 to the EU GMP Guide while PIC/S adopted it as a stand-alone GMP Guide (PE 007). The Guide has now been adopted as Part II of the PIC/S GMP Guide (see PE 009 (Part II)).
This Annex is voluntary: PE 009-16 (Annexes)
Read also: List of ICH Guidelines for Pharmaceutical Industry
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