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Compounded medicines and good manufacturing practice (GMP)

Guide to the interpretation of the PIC/S Guide to GMP for compounded medicinal products

29 May 2017

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Interpretation - complaints and recalls - chapter 8

Topic PIC/S clause Interpretation
Complaints and Recalls Chapter 8

It is expected that all suspected or serious adverse reactions related to compounded medicines will be reported to the TGA.

In addition, in circumstances where the manufacturer is made aware of any quality issue that would have resulted in recall of products these events are reported to the TGA recalls coordinator, irrespective of whether any units are recoverable, e.g. following identification of retrospective sterility testing or environmental monitoring failures.

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