In a recent press release, the PIC/S Committee recently announced the revision of the PIC/S GMP Guide (PE 009) to PIC/S version 14, with updates to:
Chapter 3 – Premises and Equipment
Chapter 5 – Production
Chapter 8 – …
In Australia, a Quality Risk Assessment is now a regular GMP activity since we saw the introduction of PIC/S Version PE 009-08, in 2009 (read more here) and the massive impact, especially of the two new clauses §1.5 and §1.6 …
Often, companies find themselves inundated with open CAPAs. This is most commonly experienced in the aftermath of an audit, where the CAPA system is used to document the issues that are identified, the investigations, the execution of corrective and/or preventative actions, and finally the closures.
This paper reviews the principles of risk management in software development of GxP systems, elaborates on the well-known risk management approaches and identifies some of the important concepts of proactive management of risks throughout the software development lifecycle.
I am often asked about wireless sensors in a GMP environment and their application. They are a very attractive option for retrofitting an existing facility because they are easy to install, tailor to the requirements, affordable and don’t require …
On 29 July 2009, Australia’s Therapeutic Goods Administration (TGA) adopted the PIC/S Guide to Good Manufacturing Practice PE009-8.
One of the single biggest changes from the previous Australian Code of Good Manufacturing Practice was, and remains, the codification of Quality …
