pics tablets

PIC/S update to PE009 – version 14 on its way

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 – …

Quality Risk Assessment

Quality Risk Assessment

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 …

Plan Do Check Act - CAPA

Maintaining Control of your CAPA system

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.

Wireless Sensors in a GMP Environment

Wireless Sensors in a GMP Environment

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 …


Useful Tips for Quality Risk Management Implementation

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 …