Why do we not risk assess? The problem is often below the surface I have recently been thinking about difficulties companies face with Quality Risk Management. It seems to me that businesses can de-prioritise quality inspections because the regulatory requirements and the business’ objectives do not, on the face of it, align. This misalignment ensures […]
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Navigating the landscape, distributing controlled drugs For those familiar with my background, you may recognize me from my days as an MHRA inspector and, more recently, my time in industry supplying pharmaceuticals to the aviation and maritime sectors. I’m eager to share the practical insights I’ve gained managing the global distribution of controlled drugs. Controlled
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Gamekeeper turned Poacher Preparing you for your Inspection Many of you might know me as an MHRA Senior GDP inspector, well not anymore. I left the MHRA in January 2022 to join SeerPharmaUK as a trainer and consultant. Am I really a ‘gamekeeper’ turned ‘poacher’? I shall leave you to decide. What I do want
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Lacking integrity? Use of Microsoft Excel in the pharmaceutical and healthcare sector Can we use Excel spreadsheets and workbooks in the pharmaceutical and healthcare sector? This is a pressing problem for many data controllers and quality managers highlighted by Terry Madigan, Senior GDP Inspector, MHRA I don’t believe it! – Terry Madigan, MHRA. There is
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Responsible Person Refresher! Everything you need to know to maintain your status. “I need to do some RP refresher training. Do I have to attend the Gold Standard Course every year or do you provide a summarised course option?” This is a typical query we receive from people acting as the Responsible Person. To
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Computer Software Assurance (CSA) and CSV A lot has been written and discussed about Computer Software Assurance (CSA) and it being a revolutionary change to Computerised System Validation. It is, in fact, not that revolutionary, but more a re-alignment of the original intent of CSV. CSA involves ‘critical thinking’, the correct use of risk assessment
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Transport Management and Good Distribution Practices (GDP) Compliance The importance of transport management in the pharmaceutical supply chain The pharmaceutical industry is responsible for producing and distributing life-saving medicines that are critical to the health and well-being of individuals. However, the effectiveness of the supply chain relies heavily on efficient transportation and logistics management. The
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Choosing a Responsible Person A guide for the WDA Licence Holder The Responsible Person is essential to every WDA holder; but what makes a good Responsible Person (RP) and how do you choose one? Is it someone who magically has 30 hours in the day? Is it someone with a good head for numbers? Is
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Use of Stability Data for Temperature Excursions in the Wholesale Supply Chain I am often asked “If I get a temperature excursion, can I justify it with the manufacturer’s stability testing data?” Well, as usual the answer is ‘it depends’! But you need to exercise a fair amount of caution here. What is Stability testing?
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Why Can’t I Use Ex-Works Is there a problem with ex-works for export of pharmaceuticals? This is a question I am frequently asked as a consultant so it seemed a good idea to share some information with you all. Why do the MHRA inspectors say we cannot use ex-works for export of pharmaceuticals? To start
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