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.
The current Therapeutic Goods (Manufacturing Principles) Determination specifies that medicinal products supplied in Australia have to meet the PIC/S Guide to Good Manufacturing Practice (GMP) - 01 May 2021, PE009-15, except for its Annexes 4, 5 and 14 which are not adopted by Australia. Through the operation of section 36 and other provisions within the Act, the PIC/S Guide to GMP has legal force in Australia.
Good Manufacturing Practice (GMP) describes a set of principles and procedures that when followed helps ensure that therapeutic goods are of high quality.
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly known as PIC/S) develop international standards between countries and pharmaceutical inspection authorities, to provide a harmonised and constructive co-operation in the field of GMP.
The PIC/S provide an active and constructive cooperation in the field of GMP and related areas. The purpose of PIC/S is to facilitate:
- networking between participating authorities
- maintenance of mutual confidence
- exchange of information and experience
- mutual training of GMP inspectors.
The TGA is a member of the PIC/S.
The PIC/S guide to GMP for medicinal products
The PIC/S Guide to GMP for medicinal products applies to all medicines (unless exempt under provisions in the Act). Interpretations of the PIC/S guide to GMP for medicinal gas manufacturers have been agreed by the TGA and the Australia New Zealand Industrial Gas Association.
The Guide is divided into two parts and a number of annexes which are common to both parts.
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- Guide to Good Manufacturing Practice for Medicinal Products - Introduction
- Guide to Good Manufacturing Practice for Medicinal Products - Part I
Part I covers GMP principles for the manufacture of medicinal products
- Guide to Good Manufacturing Practice for Medicinal Products - Part II
Part II covers GMP for active substances used as starting materials
- Guide to Good Manufacturing Practice for Medicinal Products - Annexes
The annexes provide detail on specific areas of activity. For some manufacturing processes, different annexes will apply simultaneously.
- Technical interpretation of PIC/S GMP guide Annex 1 - Manufacture of sterile medicinal products
Guide to Good Manufacturing Practice for Medicinal Products - Introduction
1 May 2021
- Adoption and entry into force
- Revision history
Guide to Good Manufacturing Practice for Medicinal Products - Part I
1 May 2021
- Pharmaceutical Quality System
- Premises and equipment
- Quality control
- Outsourced activities
- Complaints and product recall
- Self inspection
Guide to Good Manufacturing Practice for Medicinal Products - Part II
1 May 2021
- Quality management
- Buildings and facilities
- Process equipment
- Documentation and records
- Materials management
- Production and in-process controls
- Packaging and identification labelling of APIs and intermediates
- Storage and distribution
- Laboratory controls
- Change control
- Rejection and re-use of materials
- Complaints and recalls
- Contract manufacturers (including laboratories)
- Agents, brokers, traders, distributors, repackers and relabellers
- Specific guidance for APIs manufactured by cell culture / fermentation
- APIs for use in clinical trials
Guide to Good Manufacturing Practice for Medicinal Products - Annexes
1 May 2021
- Annex 1 - Manufacture of sterile medicinal products
- Annex 2A - Manufacture of advanced therapy medicinal products for human use
- Annex 2B - Manufacture of biological medicinal substances and products for human use
- Annex 3 - Manufacture of radiopharmaceuticals
- Annex 4 - Manufacture of veterinary medicinal products other than immunologicals [This Annex is not adopted by the TGA]
- Annex 5 - Manufacture of immunological veterinary medical products [This Annex is not adopted by the TGA]
- Annex 6 - Manufacture of medicinal gases
- Annex 7 - Manufacture of herbal medicinal products
- Annex 8 - Sampling of starting and packaging materials
- Annex 9 - Manufacture of liquids, creams and ointments
- Annex 10 - Manufacture of pressurised metered dose aerosol preparations for inhalation
- Annex 11 - Computerised systems
- Annex 12 - Use of ionising radiation in the manufacture of medicinal products
- Annex 13 - Manufacture of investigational medicinal products
- Annex 14 - Manufacture of products derived from human blood or human plasma [This Annex is not adopted by the TGA]
- Annex 15 - Qualification and validation
- Annex 16 - Qualified person and batch release [This Annex is not adopted by the PIC/S and Australia]
- Annex 17 - Real time release testing and parametric release
- Annex 18 - GMP guide for active pharmaceutical ingredients [This Annex no longer exists]
- Annex 19 - Reference and retention samples
- Annex 20 - Quality risk management
Technical interpretation of PIC/S GMP guide Annex 1 - Manufacture of sterile medicinal products
8 January 2010
PIC/S has published a recommendation for the technical interpretation of Annex 1 on the Manufacture of Sterile Medicinal Products.
This recommendation summarises the interpretations an inspector adopts during an inspection of the manufacture of sterile medicinal products. It reflects the most important changes introduced in the revised Annex 1 but is not intended to address all changes in the revision.
This recommendation came into effect on 1 January 2010.
- Document history
- Purpose and scope
- Definitions and abbreviations
- New texts and their interpretation
- Revision history