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

TGA interpretation and expectations for demonstrating compliance
4 September 2020
Download PE009, the PIC/S guide to GMP for medicinal products

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 Description of change Author Effective date

V1.0

Original publication

Replaces Questions and answers on the code of good manufacturing practice for medicinal products

Manufacturing Quality Branch

December 2017

V2.0

Updated following adoption of PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-14

Manufacturing Quality Branch

July 2020

V2.1

Updated to incorporate minor editorial changes

Manufacturing Quality Branch

September 2020

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