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Manufacturing inspections
Related information
- Acronyms & glossary
TGA inspectors inspect Australian and overseas manufacturers of therapeutic goods. The terms 'inspection' and 'inspector' are synonymous with the terms 'audit' and 'auditor' used by the Medical Devices Branch.
General information about TGA inspections
- Manufacturer inspections - an overview
Manufacturers of therapeutic goods are regularly inspected by the TGA using a risk-based approach to ensure compliance with GMP standards - Manufacturer inspection - typical example
Activities associated with a typical inspection include activities: before the inspection; at the inspection; after the inspection - Manufacturer inspections - a risk-based approach to frequency
The TGA employs a risk-based approach to the frequency of manufacturer inspections - Manufacturer inspections - product/process risk classifications
The emphasis and depth of manufacturer inspections, as well as the frequency of inspections are guided by the inherent risks of the product and the method of manufacture - Manufacturer compliance history
A manufacturer's compliance history is used as part of the TGA inspection frequency matrices to help determine the frequency of manufacturer site inspections - Inspections and inspectors: the complaint process
The TGA recognises that the effective management of complaints and disputes contributes to improvements in regulatory services - Inspection feedback forms
Feedback in relation to the conduct of inspections is welcomed
Audits of medical device manufacturers
- Guidance on certification audits for medical devices
The Medical Devices Branch is developing new guidance specific to medical devices
Inspections of medicine and biologicals manufacturers
- Australian manufacturing licences and overseas GMP certification: a step-by-step guide
Guidance for applicants for manufacturing licences, and sponsors and manufacturers of goods manufactured overseas that require inspection for GMP certification - Sponsor Responsibilities related to GMP clearance and certification
Guidance for sponsors of medicines manufactured overseas - Responsibilities of manufacturers of medicines and biologicals
Manufacturers of medicines, Active Pharmaceutical Ingredients (APIs), biologicals, blood and blood components and haematopoietic progenitor cells (HPCs) have responsibilities in relation to: during manufacture, informing the TGA, licence-specific responsibilities and GMP inspections. - GMP deficiencies
Any non-compliance with GMP is termed a 'deficiency' - Target timeframes for manufacturing inspections
We have target timeframes for inspections of manufacturing sites that need to manufacture in accordance with GMP
Inspections of veterinary product manufacturers
- Veterinary product manufacturer inspections
The TGA and the APVMA have established a Memorandum of Understanding for cooperation relating to medicinal products manufactured in Australia for veterinary use