Manufacturing therapeutic goods
- Manufacture of therapeutic goods
Manufacture of therapeutic goods is defined differently depending on the type of therapeutic goods.
- Good manufacturing practice - an overview
The term Good Manufacturing Practice is used internationally to describe a set of principles and procedures which, when followed by manufacturers of therapeutic goods, helps ensure that the products manufactured will have the required quality
- Manufacturer statutory declarations
Statutory declarations are required whenever certain situations or business operations change
- Technical working groups
Technical Working Groups have been established to bring together manufacturing technical expertise from industry and the regulator to address the grey areas or vagaries of the cGMP as it relates to manufacturing
- TGA - Manufacturing Quality Branch Statement regarding Data Management and Data Integrity (DMDI)
TGA has published a statement regarding Data management and data integrity (DMDI). This serves to provide clarification regarding the TGA's position regarding DMDI practices for industry.
- The TGA updates processes for the close-out of on-site GMP inspections
The process for conducting post-inspection activities have been reviewed to allow a more efficient resolution of deficiencies and close-out of inspections and to align with international practice
- 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
- Guidance on licensing/certification inspections
The TGA performs inspections of Australian manufacturers of therapeutic goods to ensure that they meet an acceptable standard of GMP or comply with QMS standards
- 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