Meningitis outbreak from US Compounding Pharmacy
As you may have heard in recent reports from the US, the deaths of 7 people and the illness of a further 91 from fungal meningitis have been traced to a batch of steroidal …
Chapter 7 of EU GMP Guide “Contract Manufacture and Analysis” revised
Chapter 7 “Contract Manufacture and Analysis” will be re-titled as “Outsourced Activities” from the 31st of January 2013. The revision will provide further clarification and guidance on “any activity covered by the GMP guide …
EU Guidelines for GMP-Chapter 1 “Quality Management” revised to align with ICH Q10
As of the 31st of January 2013, Chapter 1 will come into operation titled as “Pharmaceutical Quality System” in order to align with the concepts and terminologies described in the ICH Q10.
The current version …
The TGA and Medsafe developing an early warning system for potential safety issues with therapeutic products
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 …
CSL Biotherapies receive close-out letter from US FDA
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 …
New changes to cleanroom & clean air device classifications: ISO 14644–1 and ISO 14644–2
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 …
Regulation of Medical Apps – iPhones & other Smart Devices
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 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 …
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 …
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 …