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PE009, the PIC/S guide to GMP for medicinal products
TGA interpretation and expectations for demonstrating compliance
4 September 2020
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Description
The TGA has adopted version PE009-14 of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP), excluding Annexes 4, 5 and 14, as the manufacturing principles for:
- medicines and active pharmaceutical ingredients
- biologicals that comprise or contain live animal cells, tissues or organs
PE009-14 does not apply to:
- medical devices
- biologicals that comprise, contain or are derived from human cells or human tissues
Contents
- About PE009-14
- Quality management (Chapter 1)
- Personnel (Chapter 2)
- Premises and equipment (Chapter 3)
- Documentation (Chapter 4)
- Production (Chapter 5)
- Quality control (Chapter 6)
- Outsourced activities (Chapter 7)
- Sterile medicinal products (Annex 1)
- Biological medicinal substances and products for human use (Annex 2)
- Radiopharmaceuticals (Annex 3)
- Medicinal gases (Annex 6)
- Herbal medicinal products (Annex 7)
- Sampling of starting and packaging material (Annex 8)
- Computerised systems (Annex 11)
- Investigational medicinal products (Annex 13)
- Qualification and validation (Annex 15)
- Real Time Release Testing and Parametric Release (Annex 17)
- Reference and retention samples (Annex 19)
Version history
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