Seamus Orr Lead Consultant, offered the first ISO 13485:2016 training in Australia and New Zealand, now we are offering ISO 13485:2016 Templates for sale, our customers describe the templates as follow – “Your templates are the most high-level (as well as attractive and professional looking) of all the templates I am finding online. They are nearly double…
Data Integrity Violations Data Integrity violations or data errors can happen in 3 ways: fat finger errors (an accidental lapse by an operator), falsification (a rogue operator who enters false results) and fraud (collusion by a number of people). In this blog post, we’ll investigate how to reduce the risk of all three. With…
The review of data is the basis of everything that we do in the industry. It is the foundation of regulatory filings, controls in manufacturing, the checks in laboratory analysis, assurance of product release and so on. We continue to discuss DI issues as they continue to appear in US FDA Warning Letters, EU non-compliance…
Compounding pharmacies are in the FDA’s headlights again, with another pharmacy receiving a warning letter after an inspection, these inspections normal have findings relating to poor design of pharmacy clean rooms, i.e. CFR 211.42. Highlighted below within the text are the top 10 ranking 2014/15 FDA warning letters trends, full list here. The Warning Letter included:…
Pharmaceutical Cloud Computing As we evaluate pharmaceutical cloud computing as an option we see pharma companies are slow to adopt cloud computing services, mainly because of the perceived data security / data integrity risk and fear of regulatory interpretations. I frequently hear, “How do you validate the cloud?” or “What will the regulator say?”, but most…
Breaking news – Visual Inspection Training Course Added The National GMP & Validation Forum is quickly becoming the most supported conference to exchange ideas, thoughts and catch up with the developments in the EU and USA and how they apply these in an Australian context. The event started in 2012 with PharmOut hosting and at times leading…
The acronym ALCOA has been around since the 1990’s, is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP). ALCOA relates to data, whether paper or electronic, and is defined by US FDA guidance as Attributable, Legible, Contemporaneous, Original and Accurate. These simple principles should…
Lean Pharma Tips I think everyone has heard of the 7 Lean Manufacturing Wastes, increasingly we hear that an 8th Waste has been added – Skill. Over the years, and with my failing memory, I have learnt that I need an easy way to remember the “wastes”, especially when I’m out front training a class, so my…
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