Licence and GMP certification

Licence and overseas GMP certification applications

• Australian manufacturing licences and overseas GMP certification: a step-by-step guide
  Guidance for applicants for manufacturing licences, and sponsors and manufacturers of goods manufactured overseas that require inspection for GMP certification
• Declaration of intent to supply the Australian market
  A declaration of intent to supply is required for GMP certification applications in certain circumstances. Where supply of the product has not commenced by the time a reinspection is due, we may decide to not conduct an inspection. This may lead to the lapse of the GMP clearance.
• Variations to manufacturing licences: a step-by-step guide
  Guidance for applicants for variations to a manufacturing licence which is in force for an Australian manufacturing site, under section 40B of the Therapeutic Goods Act 1989
• Transfer of a manufacturing licence
  Guidance for Australian manufacturers who wish to transfer a manufacturing licence to another entity
• Sponsor responsibilities related to GMP clearance and certification
  Guidance for sponsors of medicines manufactured overseas

Revoking manufacturing licences

• Revoking, suspending, or varying conditions of manufacturing licences
  Manufacturers can request revocation or suspension of their manufacturing licence or the TGA can initiate revocation or suspension
• Revoking manufacturing licences for not paying the annual charge
  We can revoke a manufacturing licence if the annual charge is not paid on time

GMP clearance

• GMP clearance guidance
  Updated guidance on GMP clearance processes
• Clearance Application Assistance Tool
  The GMP Clearance Application Assistance Tool (CAAT) provides assistance in determining the general evidence requirements for your GMP clearance applications
• Evidence of GMP for prescription medicines
  Guidance for sponsors and applicants preparing applications and requests involving steps in the manufacture of medicines regulated as prescription medicines
• GMP Clearance questionnaire
  Complete this questionnaire prior to submitting your GMP clearance application and upload it as part of your evidence package on your TGA ebusiness services portal
• GMP Clearance code tables guidance
  Guidance to assist sponsors when using the code tables for GMP Clearance applications
• International agreements and arrangements for GMP clearance
  The TGA has entered into various international agreements and arrangements with other countries and regulatory authorities to support international regulatory collaboration
• Responsibilities of manufacturers of medicines and biologicals
  Manufacturers of medicines, APIs, biologicals, blood and blood components and haematopoietic progenitor cells have responsibilities: during manufacture, informing the TGA, licence-specific responsibilities and GMP inspections
• Sponsor responsibilities related to GMP clearance and certification
  Guidance for sponsors of medicines manufactured overseas

Legislation & codes of practice

Section 36 of the Therapeutic Goods Act 1989 allows the Minister for Health to determine Manufacturing Principles that are to be applied in the manufacture of therapeutic goods

• Good manufacturing practice - an overview
  The term Good Manufacturing Practice is used internationally to describe a set of principles and procedures which, when followed by manufacturers of medicines and biologicals, helps ensure that the products manufactured will have the required quality
• Manufacturing principles for medicinal products
  Medicinal products supplied in Australia have to meet the PIC/S Guide to Good Manufacturing Practice (GMP)
• S38 guidelines for Australian manufacturing licences covering multiple manufacturing sites
  Circumstances when manufacturing licence may cover two or more manufacturing sites
• Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8
  This code ensures that quality is maintained during wholesaling and sets out appropriate standards. The provisions of this code are applied through applicable state and territory therapeutic goods legislation or drugs and poisons legislation, and/or state or territory wholesaler licensing arrangements.

GMP guidance

The TGA has developed specific guidance for certain types of medicines. These offer pragmatic guidance on how compliance with GMP principles may be achieved.

GMP guidance for all medicines

• 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