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.

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