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 of Chapter 1 describes “Quality Management” and how it incorporates Good Manufacturing Practice (GMP). The new revision further clarifies that…
History of TGA & Medsafe ‘Early Warning System’ project discussions One of the projects identified by the TGA and Medsafe when they formed ANZTPA in 2011, was to develop an early warning system to assist in the communication of potential safety issues with therapeutic products. This article provides a historical overview of the efforts 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 site at Parkville received the FDA warning letter due to “a number of significant objectionable conditions relating to the facility’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 standards are published towards the end of 2012, changes will have to be made to the way every cleanroom and…
The number of medical Apps on both the Apple and Android platforms is increasing and mobile technology is increasingly being embraced by healthcare professionals, especially since the pandemic. With the increase in medical software programs and medical technology, such as robotics and diagnostic software, it’s important the manufacturers are aware of the regulatory requirements (Regulation…
The PIC/S pipeline This article is part of a historical series of discussions relating to PIC/S GMP changes (2011). 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…
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 Practices for Medicinal Products Manufacturers held in January 2011. One session, conducted by the HSA’s Boon Meow Hoe traced the history, current…
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 Goods Administration TGA – Therapeutic Goods Administration and medicinal product manufacturers. This document saw several significant changes, including; Revised Annex…
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