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.
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.
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.
