To validate something is to prove its accuracy, and temperature validation is no different. When monitoring the temperature of an environment, the proof is just as important as a result. Read this article to learn more about thermal validations and key things you need to consider before performing one.
When it comes to regulatory intelligence, change is the only constant.
Yet keeping up is more complicated than it seems for many organizations, especially in pharmaceutical industry.
Read this article to explore what businesses need to know about regulatory intelligence to stay ahead of trends.
Smart Quality is not just a catchphrase that will soon be trendy – it’s a revolution that will reshape what quality and service can do. This article will explain more about the Smart Quality framework and how it can help your companies move from a compliance-based culture to a quality-focused one.
Although track and trace programs are important to provide drug safety and prevent counterfeiting, the regulations for these programs can be very complex. This article will explore the importance of these programs and discuss common challenges in implementing them.
FDA has developed Quality Management Maturity Program (QMM) for drug manufacturers to have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. This article will explain the meaning of QMM and why do pharma companies need to develop a QMM program.
Pharmaceutical companies must be compliant with all applicable regulations and produce high-quality products. But these systems are often complicated to manage. This article explains the different compliance requirements that pharmaceutical companies must meet and how products are evaluated for quality.
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.
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.
