PE009, the PIC/S guide to GMP for medicinal products

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