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Manufacturers of medicines, Active Pharmaceutical Ingredients (APIs), biologicals (excluding class 1 biologicals), blood and blood components and haematopoietic progenitor cells have responsibilities in relation to:
- during manufacture
- informing the TGA
- licence-specific responsibilities
- GMP inspections
- post-inspection responsibilities.
For Australian manufacturers with licences, many of these responsibilities are legal requirements in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990. Section 40 of the Therapeutic Goods Act 1989 and Regulations 19 and 20 contain conditions for licence holders.
For overseas manufacturers the same responsibilities and expectations apply, unless otherwise specified.
