There is a considerable effort from some Pharmaceutical Companies into addressing cleaning issues and possible cross-contamination,...

FDA statistics, over the years (2014-2019) identified the Data Integrity (DI) events as the most cited on the Warning Letter. The year...

"Microbiological Quality Considerations in Non-sterile Drug Manufacturing" Firms must have a microbial control strategy by establishing a...

Applying risk assessment tools to determine the adequate Microbial testing for non-sterile finished drug products. A few days back, FDA...

Regulatory Requirements Regulatory issues are involved in nearly every aspect of vaccine development, manufacturing, and marketing...