PROFESSIONAL INSIGHT

 

RECENTLY PUBLISHED ARTICLES

November 2024

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

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

Lacking integrity?

Use of Microsoft Excel in the pharmaceutical and healthcare sector

October 2022
Gamekeeper turned poacher -preparing you for your inspection

You receive the MHRA letter informing you of an inspection date…. What now?

April 2023

Transport Management and GDP Compliance

The importance of transport management in the pharmaceutical supply chain

March 2023

Responsible Person Refresher!

Everything you need to know to maintain your status.

August 2021

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

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

Computer Software Assurance (CSA) and CSV

CSA involves ‘critical thinking’, the correct use of risk assessment and vendor collaboration.

June 2021 (updated December 2022)

Why can't I use ex-works?

Is there a problem with ex-works for export of pharmaceuticals?

June 2021

The face of your company?

Why delivery driver training is so much more than just going from A to B

May 2021

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

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