TGA
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.
/Public Release. View in full here.
