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Update to Manufacturing Principles for medicines, APIs & sunscreens

4 May 2020

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, (PE009-13) issued 1 January 2017 (excluding Annexes 4, 5 and 14). This guide was adopted by the TGA in 2018.

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 (PE009-14) issued, 1 July 2018, 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 provide consistency and confidence of overseas regulators in the standards that are applied globally and to promote quality assurance of inspections. This also provides harmonisation of technical standards and procedures with international inspection standards for manufacture, testing and supply of medicines

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 (PE009-14, 1 July 2018) is scheduled to commence on the 1 July 2020 at which point, GMP inspectors will use the new Guide to GMP during inspections.

Compliance with the basic requirements of the PIC/S Guide to GMP (PE009-14, 1 July 2018) will be expected from this adoption date; however, inspectors will take a pragmatic approach to discussing and reporting deficiencies relating to any new supplementary requirements.

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 (PE009-14, 1 July 2018) will generally be expected after this 12 month transition period ends.

We acknowledge the impact that the COVID-19 pandemic has and may have on the ability of manufacturers to adopt new supplementary requirements, and therefore the overall implementation period will be reviewed prior to the completion of the 12 month graduated transition period, to determine whether additional time is required.

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 (PE009-14, 1 July 2018) 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 PE009-14, 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 PE009-14.
  • Check the TGA website for regular updates on the adoption of the PIC/S Guide to GMP PE009-14.

Feedback

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 gmp@health.gov.au. Any feedback will be used to improve inspection procedures and training.