The guidance dated version 1.0 May 2021, outlines the Good Manufacturing Practice (GMP) compliance requirements for manufacturing biologicals and medicines intended for supply in Australia and TGA’s framework for managing GMP compliance signals.
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.
Sponsors and manufacturers are expected to report potential or known GMP compliance signals at their manufacturing sites and provide this information to the TGA when they become aware of such information.
These potential compliance signals include, though are not limited to:
- concerns raised by the manufacturers where it is identified there is a potential or actual breach of the Good Manufacturing Practices for medicines,bloodor biologicals, particularly where this may lead to a risk to products.
- any regulatory actions by any competent authority for the manufacturing sites.
TGA may request further information from sponsors and manufacturers after TGA has reviewed/investigated potential or known GMP signals reported to TGA. These are additional information that may be relevant to the GMP compliance signal investigation and risk assessment process. For example, TGA may request the:
- inspection report
- post-inspection letter (PIL)
- manufacturer’s responses to the regulatory authority
- evidence of corrective and preventative actions (CAPAs)
- Site Master Files (SMF)
- GMP or Quality agreements (or equivalent), where appropriate
- TGA manufacturer questionnaire
Guidance on the management of GMP compliance signals for domestic and overseas manufacturers of medicines and biologicals v1.0, May 2021: