Manufacturing medicines

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

Codes of practice

• Manufacturing principles for medicinal products
  The Therapeutic Goods (Manufacturing Principles) Determination No 1 (2009) determines the PIC/S Guide to Good Manufacturing Practice - 15 January 2009, PE 009-8, to be the Code of GMP
• Questions & answers on the code of good manufacturing practice for medicinal products
  Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2009 determines the PIC/S Guide to Good Manufacturing Practice, 15 January 2009, PE 009-8, to be the Code of GMP, except for its Annexes 4, 5 and 14 which are not adopted by Australia
• Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8
  This Code of Practice is concerned with ensuring that quality is maintained during wholesaling and it sets out appropriate standards to be applied

Guidelines & other information

• GMP clearance for prescription medicines
  Provides 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 to ensure that they meet an acceptable standard of GMP or comply with QMS standards
• Guidelines for sterility testing of therapeutic goods
  Guidance for sterility testing of therapeutic drugs and devices supplied in Australia
• Medicinal gases and good manufacturing practice (GMP)
  Guide to interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products - 15 January 2009; applicable to the manufacture of medicinal gases
• 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
• 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