ARTICLES

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

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

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

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?

Responsible Person Refresher! Everything you need to know to maintain your status.   “I need to do some RP refresher training. Do I have to

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

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

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

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

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

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”

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