Have your say on updates to Good Manufacturing Practice (GMP) Guidelines

The GMP Guidelines on Chapter 1 - Pharmaceutical Quality System are being updated to reflect contemporary Quality Risk Management principles and further improve how Product Quality reviews are performed.

Public consultation now open

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has launched a public consultation on proposed revisions to its ‘Guide to GMP for Medicinal Products’, specifically Chapter 1 - Pharmaceutical Quality System. Key updates include:

• Revision of the chapter to incorporate changes introduced in ICH Q9(R1) on Quality Risk Management
• Additional guidance for the conduct of Product Quality Reviews.

These updates have been developed by a joint PIC/S and European Medicines Agency Inspectors Working Group. More information is available in the PIC/S news article.

Why these updates matter to you

If you’re an Australian manufacturer affected by these updates, your input is important. The PIC/S Guide to GMP is embedded in Australian law under the Therapeutic Goods Act 1989. It is the mandated standard for manufacturing therapeutic goods, including active pharmaceutical ingredients and sunscreens intended for human use. It does not apply to blood products, certain cell therapies, or biologicals containing live animal material.

How to respond

If you belong to a stakeholder organisation (e.g. Industry peak body), PIC/S have requested that feedback is submitted through your stakeholder organisation. You can also provide feedback directly using the survey tool EUSurvey - Survey.

Consultation closes on 3 December 2025. It’s important to make your submission through the Commission’s website and not to the TGA.