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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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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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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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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Between a Rock and a Regulatory Place Changing the perception of RPs from Revenue Preventers to Revenue Providers A Responsible Person’s “periodic assessment and documentationof the effectiveness of learning” Being the Responsible Person in the Pharmaceuticals industry is often a thankless task. Until an inspection, of course, when deaf ears miraculously hear again… for a
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