Manufacturer inspections

• Veterinary product manufacturer inspections
• Implementation of updates to ISO 14644 Parts 1 & 2 (2015)
• Target timeframes for manufacturing inspections
• GMP deficiencies
• Make a statutory declaration

GMP guidance for all medicines

• GMP surveillance inspections and extended validity of TGA GMP certificates
  Information for manufacturers and sponsors regarding a new method for GMP inspections that will be used from 1 July 2024 and the extended validity of TGA issued GMP certificates.
• TGA expectations for overseas manufacturing sites hosting remote inspections during the COVID-19 pandemic
  Information to assist overseas manufactures who may undergo a remote Good Manufacturing Practice (GMP) inspection during the COVID-19 pandemic
• PE009, the PIC/S guide to GMP for medicinal products: TGA interpretation and expectations for demonstrating compliance
  Guidance to the interpretation of the manufacturing principles
• Release for supply of medicines
  Guidance for TGA licensed or certified manufacturers and Australian sponsors of a medicine manufactured under the PIC/S Guide to GMP for medicinal products (PIC/S Guide to GMP)
• Releasing medicines manufactured at multiple sites
  Guidance for sponsors or manufacturers of a medicine manufactured across multiple sites
• GMP information for manufacturers of compounded medicines and DAAs
  Guidance is for licenced manufacturers and community pharmacists involved in the manufacture of compounded medicines or dose administration aids (DAAs)
• Compounded medicines and good manufacturing practice (GMP)
  Guide to the interpretation of the PIC/S guide to GMP for compounded medicinal products
• 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
• 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.

Sterile medicines

• Implementation of updates to ISO 14644 Parts 1 & 2 (2015)
  Information relating to the qualification of cleanrooms for manufacturers of sterile therapeutic goods
• Guidelines for sterility testing of therapeutic goods
  Guidance for manufacturers and the TGA, on performing the test of sterility for sterile Therapeutic Goods, including how the TGA performs referee testing when results are in dispute
• Manufacture of sterile radiopharmaceuticals labelled with fluorine-18
  Guidance for TGA licensed manufacturers of positron emission tomography (PET) sterile radiopharmaceuticals labelled with fluorine-18, about the application of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009 (PIC/S Guide to GMP)

Listed and complementary medicine GMP guidance

• Ongoing stability testing for listed and complementary medicines
  Technical guidance on the interpretation of the PIC/S Guide to GMP
• Process validation for listed and complementary medicines
  Technical guidance on the interpretation of the PIC/S Guide to GMP
• Product Quality Reviews (PQRs) for listed and complementary medicines
  Technical guidance on the interpretation of the PIC/S Guide to GMP
• Sampling and testing for listed and complementary medicines
  Technical guidance on the interpretation of the PIC/S Guide to GMP
• Supplier assessment, approval and qualification for listed and complementary medicines
  Technical guidance on the interpretation of the PIC/S Guide to GMP

Specific medicines

• Sunscreen manufacturing: demonstrating compliance with the PIC/S Guide to GMP PE009-13
  Clarifies the GMP requirements for manufacturing sunscreens
• Information for Australian manufacturers of medicinal cannabis products
  Information on expectations for licensing authorisations and conditions
• Medicinal cannabis manufacture
  Technical guidance on the interpretation of the PIC/S Guide to GMP
• Medicinal gases and good manufacturing practice (GMP)
  Guide to interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products