This section is for manufacturers of medicines. You should also see 'Manufacturing basics' which includes information for manufacturers of all types of therapeutic goods.

On this page: Codes of practice | Guidelines & other information

Codes of practice

• Manufacturing principles for medicinal products
  Medicinal products supplied in Australia have to meet the PIC/S Guide to Good Manufacturing Practice
• Questions & answers on the code of good manufacturing practice for medicinal products
  Answers to questions about the manufacturing principles
• Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8
  Ensuring that quality is maintained during wholesaling and setting out appropriate standards

Guidelines & other information

• Compounded medicines and good manufacturing practice (GMP)
  Guide to the interpretation of the PIC/S guide to GMP for compounded medicinal products
• Implementation of updates to ISO 14644 Parts 1 & 2 (2015)
  Information for manufacturers of sterile therapeutic goods
• GMP clearance for prescription medicines
  Detailed information on how to obtain GMP clearance for overseas manufacturers
• Guidance on licensing/certification inspections
  The TGA performs inspections of Australian manufacturers of therapeutic goods
• Guidance on release for supply
  Release for supply is a mandatory step in manufacture
• Guidelines for sterility testing of therapeutic goods
  Guidance for manufacturers and the TGA, and for referee testing when results are in dispute
• Manufacture of medicinal cannabis for supply under 'approved access' provisions
  Guidance on GMP compliance for the manufacture of medicinal cannabis for supply under ‘approved access’ provisions
• Medicinal gases and good manufacturing practice (GMP)
  Guide to interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products
• S38 guidelines for Australian manufacturing licences covering multiple manufacturing sites
  Circumstances when manufacturing licence may cover two or more manufacturing sites
• Site master file preparation: PIC/S explanatory notes for pharmaceutical manufacturers
  A Site Master File is a document prepared by a manufacturer that provides information about the production and control of manufacturing operations at a named site, as well as any closely related operations in nearby buildings
• Technical guidance on the interpretation of manufacturing standards
  These guidance documents typically focus on one specific area within a manufacturing standard in relation to a specified group of manufacturers
• Veterinary product manufacturer inspections
  The TGA and the APVMA have established a Memorandum of Understanding for cooperation relating to the licensing and inspection of medicinal products manufactured in Australia for veterinary use