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 has now been incorporated by the EU. Annex 14 Medicinal Products Derived from Human Blood...
The PIC/S Pipeline Part 4 of 4
The PIC/S GMP Pipeline Part 3 of 4
In January of 2011, the Health Products Regulation Group (HPRG) of Singapore’s Health Sciences Authority (HSA ) held a regulatory workshop on Good Manufacturing Practices for Medicinal Products Manufacturers. One session, conducted by the HSA’s Boon Meow Hoe traced the history, current applicability and future trends of PIC/S GMP....
Current PIC/S Guides to GMP Part 2 of 4
Current PIC/S 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 Goods Administration TGA – Therapeutic Goods Administration and medicinal product manufacturers. This document saw several...
Past, Present and Future PIC/S GMP Part 1 of 4
In January of 2011, the Health Products Regulation Group (HPRG) Health Sciences Authority (HSA) held a regulatory workshop on Good Manufacturing Practices for Medicinal Products Manufacturers. One session, conducted by the HSA’s Boon Meow Hoe, traced through the history, current applicability and future trends of PIC/S GMP. PIC/S History...
New Chinese GMP
New GMP guidelines were issued by the Chinese SFDA in Feb. 2011 and will come into force starting from March 1st 2011. The requirements of the new revision are very similar to the EU GMPs and are consistent with the requirements of WHO GMP. All new pharmaceutical facilities in China...
TGA requirements for sampling and testing of complementary medicines
What the requirements are and how to cost effectively comply The TGA’s code of GMP recommends that all suppliers be qualified – “The process of assessing the reliability of a supplier to consistently provide material of acceptable quality”. For complementary manufacturers with many, many suppliers, qualifying them all is...
Why PIC/S compliance is so important
With the US FDA joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S), compliance with the PIC/S GMP standards should be a priority for any pharmaceutical manufacturer exporting to multiple countries. What is PIC/S? As described on the PIC/S website,the mission of the PIC/S organisation is ” “to lead the...