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.
Stay updated on latest GMP trends through our webinars and articles
Annex 1 of the European Union’s Good Manufacturing Practices (GMP) Has Been Published- Find Out What’s New
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.
What makes the pharma industry tick, how new drugs come to market and why are they so expensive?!
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?