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Transition to new GMP requirements for medicinal products

A notice about the implications of adopting the PIC/S Guide to GMP PE009-14
22 June 2020
Download Transition to new GMP requirements for medicinal products

Description

The TGA will adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-14 (PIC/S Guide to GMP), excluding Annexes 4, 5 and 14, as the manufacturing principles for medicines and active pharmaceutical ingredients, with effect from 1 July 2020 as communicated on 4 May 2020. The PIC/S Guide to GMP is available from the PIC/S website.

This will replace the manufacturing principles adopted in 2018 by the TGA for the manufacture of medicines, active pharmaceutical ingredients and sunscreens: the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-13.

This notice is being issued to assist with the transition period. It is a point-in-time document and we are not planning on updating this notice.

We will be updating GMP guidance during 2020 to reflect the new requirements.

Contents

  • A notice about adoption of a new PIC/S guide to GMP
  • New and amended GMP requirements
  • Transition plan

Version history
Version Description of change Author Effective date
V1.0 Original publication Manufacturing Quality Branch June 2020

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