Manufacturing basics: Medicines and biologicals

Links to information on good manufacturing practice (GMP), manufacturing inspections and manufacturer statutory declarations.

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
Guidance on the management of GMP compliance signals
Outlines the Good Manufacturing Practice (GMP) compliance requirements (according to the Manufacturing Principles for manufacturing biologicals and medicines intended for supply in Australia and our framework for managing GMP compliance signals
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)

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