Understanding GMP Requirements for Pharmaceutical Quality Control Laboratories
Introduction Good Manufacturing Practice (GMP) is the foundation of pharmaceutical quality systems. GMP requirements are designed to ensure that pharmaceutical products are consistently produced, tested and controlled according to established quality standards. For Quality Control (QC) and microbiology laboratories, GMP compliance plays a critical role in ensuring the reliability, accuracy and integrity of laboratory testing […]
Why Are Endotoxins Dangerous? Understanding the Risks in Pharmaceutical Products
Introduction Patient safety is the foundation of pharmaceutical manufacturing. While much attention is given to microbial contamination, another significant risk that quality control laboratories must manage is the presence of bacterial endotoxins. Even at extremely low concentrations, endotoxins can cause serious adverse reactions in patients. This is why pharmaceutical manufacturers, biotechnology companies and medical device […]
What Is Bacterial Endotoxin Testing (BET)?
A Guide for Pharmaceutical Laboratories Introduction Bacterial Endotoxin Testing (BET) is a critical quality control process used throughout the pharmaceutical, biotechnology and medical device industries. The purpose of BET is to detect and quantify bacterial endotoxins that may be present in products intended for human use. Because endotoxins can trigger serious adverse reactions even at […]