Product Quality Reviews – The Right Approach

Quality Management Systems (QMS), be it ISO or PIC/S, mandate that system reviews must occur. Product Quality Reviews (PQR) can provide the ideal platform not solely to fulfill a compliance requirement but to give …

Cultural Change Methodology as a Competency

Why do we resist change? What does this mean in our regulated environment?
Ever wondered why the same errors happen in your regulated facility?
Or why the most experienced operators continue to make the same mistakes?
Do …

TGA to revise guides for complementary medicines

The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) was first published in 2001 to provide information on the supply and use of complementary medicines. The TGA is currently reviewing and restructuring the guidelines for …

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The PIC/S Pipeline Part 4 of 4

The PIC/S pipeline
Continuing on from our last post, the following changes are happening or have happened to the PIC/S GMPs:

Annex 2 Biological Medicinal Products has progressed through the public consultation phase.

Annex 11 Computerised Systems …

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The PIC/S GMP Pipeline Part 3 of 4

In trying to work out what is in the PIC/S GMP Pipeline we examined the Health Products Regulation Group (HPRG) of Singapore’s Health Sciences Authority (HSA ) held a regulatory workshop on Good Manufacturing …

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Current PIC/S GMP Guides – Part 2 of 4

Current PIC/S GMP Guides
On January 15, 2009 the PIC/S The Pharmaceutical Inspection Cooperation Scheme – PIC/S released its ‘PE009-8’ Guide to GMP document. This is the current code of GMP relevant to Australia’s Therapeutic …