The first references to the term “dedicated facility” appeared in GMP literature in the early 2010s in response to potential cross contamination risks of manufacturing toxicologically sensitive products in shared facilities. The WHO Technical …
New PIC/S GMP version 13
The TGA finally formally announced adoption of the new PIC/S GMP version 13 (PE009-13, 1 January 2017) which is scheduled to commence on 31 December 2017!
In this public statement the TGA …
Data integrity might appear to be a “buzz” word for regulators and management, but as the Volkswagen scandal involving 90,000 cars and the Qantas “tailstrike” incident indicate, it is of paramount importance in all …
