PIC/S GMP Guide 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 materials)
Annex 9 (Manufacture of
liquids, creams and ointments)
Annex 10 (Manufacture of
pressurised metered dose aerosol preparations for inhalation)
Annex 11 (Computerised systems)
Annex 12 (Use of ionising
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 [Qualified 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
