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Manufacturing basics
- Manufacture of therapeutic goods
Manufacture of therapeutic goods is defined differently depending on the type of therapeutic goods. - 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 - 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 medicines and biologicals, 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 - TGA-Industry Working Group on Good Manufacturing Practice (GMP) (TIWGG)
Established to facilitate consultation between TGA and the industry on matters relating to good manufacturing practice (GMP)