PIC/S Version 13 is here, are you ready?
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PIC/S Version 13 is here, are you ready?

For Australian and New Zealand Manufacturers PIC/S Version 13 is due this year, aside from significant changes in Part 1, there are also significant changes in Annex 11, Computers Systems and Annex 15, Qualification and Validation. We plan to help you get ready now for the pending change. Following on from the highly successful PIC/S…

2015 MHRA GMP Inspection Deficiency Data Trends
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2015 MHRA GMP Inspection Deficiency Data Trends

The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. It is the equivalent of the TGA (Therapeutic Goods Administration) here in Australia. Both administer compliance matters in Good…

New Revision of PIC/S GMP Guide (PIC/S PE 009-13) Now Live
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New Revision of PIC/S GMP Guide (PIC/S PE 009-13) Now Live

On 1st of January 2017, revision 13 of the PIC/S Code of GMP for medicinal products (PIC/S PE 009-13) entered into force. Four Chapters  of PIC/S PE 009-13 were revised to align with the current EU GMP code and ICH Q10. This was conducted “with some minor differences in terms of language“. The PIC/S website…

Outdated Australian GMPs – Should we be doing more to protect our "brand Australia"?
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Outdated Australian GMPs – Should we be doing more to protect our "brand Australia"?

As the gap between current EU/PIC/S GMPs and Australian GMPs widens, is the TGA losing relevance? Last week, I was speaking with a respected Senior Quality Executive from a leading Australian pharmaceutical manufacturer, I was surprised when they stated that they no longer prioritised TGA inspections or findings. This is in stark contrast with my…