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Update to manufacturing principles for medicines, APIs and sunscreens
The TGA's Manufacturing Quality Branch (MQB) is responsible for the assessment, inspection and licensing/certification of manufacturers of medicines supplied to, or exported from Australia.
The current Manufacturing Principles adopted by the TGA for the manufacture of medicines, active pharmaceutical ingredients and sunscreens is the PIC/S Guide to Good Manufacturing Practice, (PE009-8) issued 15 January 2009 (excluding Annexes 4, 5 and 14). This guide was adopted by the TGA in 2010.
The intent of this notice is to provide early notification that the TGA intends to adopt the current version of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-13) issued, 1 January 2017, as the Manufacturing Principles for medicines, active pharmaceutical ingredients and sunscreens.
Why is the TGA adopting the new version of the Guide to GMP?
Good Manufacturing Practices change over time due to various reasons such as to:
- Provide guidance for the management of new technologies;
- Address gaps in existing compliance requirements;
- Manage risks identified through inspections and regulation;
- Facilitate continuous improvements in the way medicines are manufactured.
The TGA uses internationally harmonised manufacturing standards to allow manufacturers to operate in an international environment. The TGA maintains its GMP standards in line with updates issued through the PIC/S. Regular updates are necessary to maintain mutual confidence with regulators overseas and to promote quality assurance of inspections and harmonisation of technical standards and procedures with international inspection standards for the production and testing of medicinal products.
Australian manufacturers benefit from reduced regulatory burden where the TGA is able to adopt harmonised international standards and establish mutual recognition agreements and cooperation arrangements with comparable overseas regulatory authorities.
How will the new guide to GMP be adopted?
This initial adoption of the PIC/S Guide to GMP (PE009-13, 1 January 2017) is scheduled to commence on 31 December 2017 at which point, GMP inspectors will use the new Guide to GMP during inspections.
Compliance with the requirements of the PIC/S Guide to GMP (PE009-13, 1 January 2017) will be expected from this adoption date; however, inspectors will take a pragmatic approach to discussing and reporting deficiencies.
A 12 month graduated transition period will be provided to allow manufacturers time to assess the new supplementary requirements contained in the new Manufacturing Principles and implement changes to procedures and practices to fully comply with the new guide.
An incremental adoption plan has been developed which outlines incrementally increasing expectations for compliance throughout the 12 month transition period. The incremental adoption plan explains the position an inspector will adopt during inspection of a manufacturer at each time point. This plan will be published by the TGA prior to the initial adoption date.
Full compliance with the PIC/S Guide to GMP (PE009-13, 1 January 2017) will be expected after this 12 month transition period ends.
The TGA has participated at a range of industry consultations over the past year and will continue to work with industry to develop further interpretive guidance where required. Further details regarding TGA information sessions regarding the adoption of the PIC/S Guide to GMP (PE009-13, 1 January 2017) will be published on the TGA website in the near future.
What action do manufacturers need to take now?
Manufacturers are encouraged to:
- Review the PIC/S Guide to Good Manufacturing Practice PE009-13, available from the PIC/S website and ensure you are familiar with the main changes and requirements relevant to your manufacturing operations.
- Commence preparations within your organisation in anticipation of the adoption of the PIC/S Guide to GMP PE009-13.
- Check the TGA website for regular updates on the adoption of the PIC/S Guide to GMP PE009-13.
The TGA welcomes feedback that helps processes be improved. Any feedback regarding these changes or their implementation may be given to the TGA via the email firstname.lastname@example.org. Any feedback will be used to improve inspection procedures and training.