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.
Temperature maps are used in numerous industries and processes to allow for accurate temperature measurements and to improve product quality and productivity. It creates a map that displays temperature values over a set period of time, in a laboratory or in a production process. This article will explain what temperature mapping is and what benefits it provides when it comes to quality control and production.
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.
Steam is used to power many processes in the energy sector, such as power turbines and sterilize equipment in the medical industry. This highly flexible gas comes in two forms: pure steam or clean steam which is generated from completely purified water. This article will explain the differences between pure and clean steam, and why each type is essential.
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.
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.
