Question Regarding PIC/S PE009-14

The current GMPs in Australia adhere to the PIC/S Guide to Good Manufacturing Practice, (PE009-13). This guide was adopted by the TGA in 2018 and the TGA has “just given” notice that it intends to adopt the current version of the PIC/S Guide (PE009-14) by July 1st 2020.

The Question posed on LinkedIn:

I have read PIC/S guidelines, when I was working in Pharmaceutical company. Currently, I am not working in Pharmaceutical company. I would like to keep my knowledge updated about what’s new in regulatory guidelines in Pharmaceutical. Would you please let me know, where can I get copy of new PIC/S??

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About 20% of (FDA) Recalls are Due to Microbial Contamination.

As of March 4 2020, 16 of the last 50 recalls by the FDA for pharmaceutical products were due to microbial contamination or a lack of  sterility assurance.  Another 27 were due to impurities with 5 more due to mislabeling.  Looking at TGA recalls for 2019, around half of the medicine recalls due to contamination were the result of microbial contamination. Continue reading

TGA Inspection Trends

My reply to a post on LinkedIn.

Current TGA Inspection trends: This presentation will focus on the common types of deficiencies found by the TGA’s GMP Inspectors as well as some data on the number of inspections performed both locally and overseas and compliance rating outcomes for the inspections performed.

Comment 1 stated “…there are patterns that seem to repeat year after year. Poor QMS, inadequate investigations, lack of training.”

My reply to this was:

“The PIC’S guide to GMP stresses the need for a robust QMS and repeats over and over again the need for documentation, solid investigations and adequate training and retraining. It is a wonder why citations regarding a lack of these keep being given.” Continue reading

Notes on Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002)

When it was current, I reviewed the Australian code of good manufacturing practice for medicinal products (16 August 2002) so I was aware of the pertinent details in relation to viable environmental monitoring and testing.

The Australian Code of Good Manufacturing Practice for Medicinal Products 2002 was revoked effective from 1 July 2010 and replaced by the PICS Guide for Good Manufacturing Practice for Medicinal Products 2009, as adopted in Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2009. The 2002 GMP Code for Medicinal Products remains available here for comparison purposes. Continue reading