Tech Talk

Quality Culture For The 21st Century - Is your Quality Culture Fit for Purpose?

If you Google ‘culture’ be prepared for days of reading. Let’s just say, for the sake of expediency, that culture is defined by the actions taken, under pressure, when nobody is looking. Like a moral compass, your Quality Culture keeps you heading in the right direction no matter how stormy and ...

Supply Chain Assurance

As the European Union tries to get a grip with counterfeit medicinal products through legislation, Pete Gough discusses the headache globalisation of pharmaceutical API manufacture is causing to the industry.

An updated version of this article was published by Scrip Regulatory Affairs in March...

OTC Medicines - High or Low Risk

In many countries around the globe certain medicines, with a long history of use giving us confidence in the safety and efficacy of the active substance molecule itself, are allowed to be sold ‘over the counter’ (OTC) at certain doses without a prescription. So the safety and efficacy are well k...

Excellent Advice on Hiring and Working with a GMP Consultant

There are numerous pharmaceutical blogs on the internet; some of them good, some bad and some downright ugly! There is one, however, which is consistently excellent and should be read by everyone with a true interest in pharmaceutical quality management – it is called The QA Pharm (theqapharm.bl...

Performing Effective, Value-Adding Audits and Self-Inspections

One of the most challenging activities in the health science industries, but without doubt one of the most important.

Bob Pietrowski explains why audits are central to the establishment and maintenance of a comprehensive Quality Management System and provides some tips on how to get the most o...