There are several terms in regulated temperature control in pharma. This article will explain the meanings and the terms ambient, room temperature, and cold chain.
The European Commission has published the long-awaited Annex 1 to the EU-GMP. The annex brings significant changes to the requirements for manufacturing sterile medicinal drugs.
Learn about FMEA, a critical risk analysis tool and how to use it in the pharmaceutical industry.
Remote audits in the GMP world, have become a necessity because of the COVID-19 pandemic. Qualifyze posses a lot of experience with remote audits and shares their helpful insights through this case study.
This article explains what are deviations and gives a framework on how to efficiently and correctly deal with them in a GMP environment.
In this article I will give you five reasons and explain to you how external auditors can save your organization a lot of trouble and money.
Companies in regulated environments need quality management software to get stronger, fitter, and smarter. But as they search, their options multiply, and confusion mounts, especially regarding the choice between on-premise and cloud QMS. So what should you choose?
Download our free Ultimate FMEA Guide, which is dedicated to GMP and pharma professionals.
This extensive yet simplified guide to Failure Mode and Effects Analysis (FMEA) will help you master one of the most vital instruments in your risk management toolbox.
