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

TGA interpretation and expectations for demonstrating compliance
22 July 2020
Download 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


  • 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)

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