You are here
Guidance on the management of GMP compliance signals
Download pdf - 748.3 KB
Download docx - 617.12 KB
Description
The guidance outlines the Good Manufacturing Practice (GMP) compliance requirements (according to the Manufacturing Principles) for manufacturing biologicals and medicines intended for supply in Australia and our framework for managing GMP compliance signals.
GMP is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that each batch of a therapeutic good is safe, reliable and of consistent high quality.
This guidance applies to:
- licensed manufacturers in Australia
- sponsors responsible for any overseas site in the manufacture of a medicine or active pharmaceutical ingredient (API) supplied to Australia.
This guidance is not intended for manufacturers and sponsors of medical devices.
Contents
We aim to provide documents in an accessible format. If you are having problems using a document with your accessibility tools, please contact us for help.