Australia Adopts Updated Good Manufacturing Practice (GMP) Guide for Sunscreens

Background

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an informal cooperative arrangement between regulatory authorities in the field of Good Manufacturing Practice (GMP) of medicinal products. It aims to ensure the quality of drug products and remove trade barriers by developing common GMP standards. ¹

As a member of PIC/S, Australia’s Therapeutic Goods Administration (TGA) adopts the PIC/S Guide to GMP for Australian sponsors and manufacturers of medicines, active pharmaceutical ingredients (APIs) and sunscreens made or supplied in Australia. However, the TGA does not automatically adopt new versions of the PIC/S Guide for medicinal products. For instance, although version 15 of the GMP guide was replaced by version 16 by PIC/S in February 2022, the TGA had been adhering to the previous version 15 until June 2024.

Australia’s Updated GMP Guide

On June 3, 2024, the TGA announced the adoption of PIC/S Guide to GMP version 16, unless exempt under the provisions of the Therapeutic Goods Act 1989 (the Act). This update includes clarifications to the existing Annex 13 and introduces a new Annex 16, which addresses authorized person and batch release. The status of Annexes 4, 5, and 14 remains unchanged.

Notably, the new Annex 16 will apply to therapeutic goods manufactured from September 3, 2024, allowing a three-month transition period for manufacturers to review and implement necessary operational changes. By then, manufacturers shall have finished the assessment of the impact of Annex 16 on their operations and completed the update of their quality systems documentation and the implementation of revised practices.

Highlights of Annex 16

Annex 16 is comprised of seven sections, including the scope, the certification process, GMP assessment by third parties (e.g., audits), the handling of deviation, batch release, glossary and appendices. It provides guidance on the certification by an authorized person and on the batch release of medicinal products for human or veterinary use within a PIC/S participating authority or for export.

1. The Authorized Person

The Authorized Person is responsible for ensuring that each individual batch has been manufactured and checked in compliance with national requirements according to the requirements of the marketing authorization (MA) and GMP.

2. The Process of Batch Release

i. Medicinal product batches should only be sold or supplied to the market after being certified by the authorized person. Until certification, they should remain at the manufacturing site or be shipped under quarantine to another approved site.

ii. Safeguards, whether physical (like segregation and labeling) or electronic (like validated computer systems), should be in place to prevent the transfer of uncertified batches to saleable stock. When uncertified batches are moved from one authorized sites to another, these safeguards should remain.

iii. The steps to notify Authorized Person certification to the site where the transfer to saleable stock is to take place should be defined within a technical agreement. Such notification by an Authorized Person to the site should be formal and unambiguous and should be subject to the requirements of the PIC/S GMP Guide, Part I, Chapter 4

iv. National law may require a specific release for the local market by the Marketing Authorization Holder (MAH). In this process, the manufacturer’s certification of the finished product should be considered