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List of PICS 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 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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