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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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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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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The Face of Your Company? Why delivery driver training is so much more than just going from A to B “Be the face of something” Definition: to represent the nature or character of an organization, industry, system etc, and the way it appears to people. For Pharmaceutical Wholesalers, your truck delivery isn’t just a vital
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