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Implementation of the PIC/S guide to GMP PE009-13
On 1 January 2018 the TGA adopted new manufacturing principles to be observed by manufacturers of medicines and active pharmaceutical ingredients under Section 36(1) of the Therapeutic Goods Act 1989.
The new manufacturing principles have mandatory effect from 1 January 2018; however, we do not expect all manufacturers to have data immediately available to meet some of the new requirements. As a result, a phased approach is being taken to assessing compliance with these items during our on-site inspections.
In support of the adoption of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-13, we have published:
- a notice outlining the main amendments in the guide, the arrangements for a 12 month transition period and how deficiencies will be categorised
- detailed guidance regarding the TGA's interpretation and expectations for compliance with the PIC/S Guide to GMP PE009-13
- The legislative instruments that determine the manufacturing principles
We strongly encourage you to familiarise yourselves with, and start using, the new GMP guidance and associated notices as soon as possible.
Consultation and feedback
During our preparation to adopt the new manufacturing principles we have consulted with key industry associations. We will continue to work with industry to develop further interpretive guidance where required.
If you have any questions or feedback regarding the adoption of the PIC/S Guide to GMP PE009-13 contact the Manufacturing Quality Branch.