Day: January 23, 2025

Investigating and addressing deviations in the manufacturing process is a critical requirement for compliance with Good Manufacturing Practices (GMP). A Warning Letter (WL) issued to Sanofi’s drug manufacturing facility in Paris highlights the procedural deficiencies that all manufacturing facilities should address to stay GMP compliant.    Deviations from the process could happen for various reasons. … Read more

Many clinical trials involve collecting tissues from trial participants as a part of the clinical protocol which inherently adds varying degrees of risk to the participants. The FDA has specified conditions under which biopsies could be collected and the processes involved to adequately control the amount, type, and quality of the tissue sample collected in … Read more