Manufacture a medicine

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- external site and the Therapeutic Goods Regulations 1990- external site. 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.

Key information for industry

• Manufacturing basics
• Manufacturing medicines
• Responsibilities of manufacturers of medicines and biologicals
• Manufacturing basics - Medicines and biologicals
• PE009, the PIC/S guide to GMP for medicinal products
• Notices for manufacturers
• Notices about GMP clearance