The TGA, Australia has issued guidance on GMP compliance requirements and framework for managing GMP compliance signals.
The 17 page guidance document outlines:
- the Good Manufacturing Practice (GMP) compliance requirements according to the Manufacturing Principles for manufacturing biologicals and medicines intended for supply in Australia
- the TGA framework for managing GMP compliance signals (or non-compliance alerts). See further information on GMP compliance signals below.
Who does the guidance apply to?
It 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.
The guidance is not intended for manufacturers and sponsors of medical devices.
About GMP compliance signals (or non-compliance alerts)
GMP compliance signals (or non-compliance alerts) include but are not limited to the following that the TGA receives from from various internal and external intelligence sources:
- intelligence
- data
- information
GMP compliance signals also include TGA inspections and routine compliance monitoring process which indicate a departure from the manufacturing principles (or equivalent overseas standards) by a manufacturer.
In addition, for overseas manufacturing sites TGA performs routine monitoring of overseas
compliance systems and databases published by other overseas regulatory authorities.
Source: TGA website