Quality professionals in GMP therapeutic goods manufacturing wear many hats – guardian of compliance, champion of patient safety, and pragmatic problem-solver when timelines are tight. If your New Year resolution is to make Quality feel more manageable (and even a little more celebratory), this toolkit brings together practical resources, training and technologies you can adopt…
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…
So, you’re working for an exciting brand-new start-up. It’s getting to the pointy end – you understand all your processes, but you need to have these documented and in place to control and direct your regulated activities, ready for your initial regulatory inspection. Or perhaps your business is evolving – you need to incorporate regulation-driven…
Corrective and Preventive Action (CAPA) is a key process within a pharmaceutical quality management system. It is the process of identifying and documenting corrections and improvements to systems and processes to reduce the risk of a deviation, non-conformance or quality issue occurring or recurring (hereafter referred to as an ‘issue’). A CAPA record must include…
In this blog I would like to share my 10 tips for writing user friendly SOPs as part of your GMP Pharmaceutical Quality System. The other day I was informed by a client that no-one on their site reads procedures and the only function SOPs performed was ticking a compliance check-box. In my experience this…
Once the Pharmaceutical Quality System (PQS) (as per ICHQ10: Pharmaceutical Quality System) is implemented, it must be ensured that it continues to be effective, and for this to happen there has to be a clear commitment from senior management to a Quality Culture. There are several ways senior management can demonstrate their commitment to the…
‘Continuous Improvement’ or ‘Continual Improvement’ within a quality system can be described as a process of ongoing improvement of products, services or processes through incremental and/or breakthrough improvements. Within the Pharmaceutical Industry, it’s important that companies ask themselves how continuous improvement has been built into the Pharmaceutical Quality System (PQS). The term may appear in…
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