PIC/S GMP Guide Annexes


PIC/S GMP Guide Annexes:

Click the titles below for complete guidelines

Table of contents

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


PIC/S GMP Guide Annexes:

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