How to Thrive, Not Just Survive, in QA This Year As the holiday season winds down and the New Year kicks off, many of us are thinking about what the coming year holds. For quality professionals in the therapeutic goods industry, this is the perfect time to set goals that not only improve compliance through…
When budgeting for personnel to attend conferences and networking events, decision-makers often prioritise costs and potential downtime over the long-term benefits. However, investing in professional development (PD) opportunities for life science professionals can lead to significant productivity gains and financial returns. Professional Development is best viewed as an ‘uptime’ opportunity vs a ‘downtime’ event. That’s…
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 – Complaints and Product Recall According to PIC/S, these chapters have been revised based on the equivalent…
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 (Part 1 of the PIC/S GMP) had on the Australian industry, as we followed the USFDA…
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 expensive cabling or wall penetrations. The following details will help you determine your requirements in this…
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 Risk Management (QRM). The industry was unprepared for the impact of QRM and, although the…
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