GMPs

Product Quality Reviews

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

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

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 …