As a result of the Statement of intent by Australia and New Zealand in June 2011, the Australia New Zealand Therapeutic Products Agency (ANZTPA) was formed as a joint scheme for the regulation of …
On August 10th, the US Food and Drug Administration (FDA) issued a statement that signalled the completion of their evaluation of CSL’s corrective actions in response to the Warning Letter received in June 2011.
CSL’s …
This white paper describes the changes outlined in the Draft International Standard (DIS) editions of ISO 14644-1 and ISO 14644-2 relating to clean room & clean air device classifications: ISO 14644–1 and ISO 14644–2.
When the …
The number of medical Apps on both the Apple and Android platforms is increasing and mobile technology is increasingly being embraced by healthcare professionals. App developers should be aware that some software intended to …
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 …
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 …
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 …
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, …
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 …
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 …
