PROFESSIONAL INSIGHT
RECENTLY PUBLISHED ARTICLES
November 2024
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Why do we not risk assess?
Potential underlying reasons why risk assessments don’t happen and some thoughts that may help resolve them
March 2024
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Distributing controlled drugs
Controlled drugs are known to be susceptible to misuse and abuse, and therefore necessitate a stringent and secure supply chain environment…
May 2023
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Lacking integrity?
Use of Microsoft Excel in the pharmaceutical and healthcare sector
October 2022
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Gamekeeper turned poacher -preparing you for your inspection
You receive the MHRA letter informing you of an inspection date…. What now?
April 2023
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Transport Management and GDP Compliance
The importance of transport management in the pharmaceutical supply chain
March 2023
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Responsible Person Refresher!
Everything you need to know to maintain your status.
August 2021
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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?
July 2021
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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.
May 2022
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Computer Software Assurance (CSA) and CSV
CSA involves ‘critical thinking’, the correct use of risk assessment and vendor collaboration.
June 2021 (updated December 2022)
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Why can't I use ex-works?
Is there a problem with ex-works for export of pharmaceuticals?
June 2021
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The face of your company?
Why delivery driver training is so much more than just going from A to B
May 2021
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Between a rock and a regulatory place
This article looks at one particularly taxing aspect of an RP’s role, the periodic assessment and documentation of the effectiveness of learning