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Tech Alert: GMP Version 14 - Member questions and issues

05 Feb 2021 9:43 AM | Anonymous member (Administrator)

This Thursday, CMA and a number of key manufacturing representatives are meeting with the TGA to identify questions or issues relating to the implementation of version 14 of the PIC/S Guide to GMP (PE009, the PICS/S guide to GMP for medicinal products).

Version 14 of the PIC/S Guide was adopted last year with a transition period, and full compliance will be expected from July 2021. As a general reminder, compliance expectations for the TGO 101 Section 16 - elemental impurities and residual solvents will also come into effect at this time.

If members have questions, issues or problems relating to the implementation of  Version 14 PIC/S GMP, please email Lucy.Lang@cmaustralia.org.au by COB Wednesday. The process is to identify whether there is a need to modify any current TGA GMP guidance (to improve clarity) or to create any new TGA GMP guidance (if required) from an industry perspective.

Resources:

- Technical Alert Summary of Version 14 GMP changes

- Current TGA interpretation and expectations for demonstrating compliance

- Listed and Complementary medicine GMP guidance

- TGO 101 Standard for capsules, tablets and pills


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