A GLANCE AT DATA INTEGRITY Data Integrity is a cornerstone of the Quality Culture. The specific culture of an organization is connected...

Test Results for Pharmaceutical Production Guidance for Industry (May 2022)

Assessments Guidance for Industry dated May 2022) General Comments Comments and suggestions regarding this draft document should be...

Today, FDA announced the availability of a draft guidance for industry, Benefit-Risk Considerations for Product Quality Assessments. This...

There are a few key things to look for when searching for a good consulting firm to help with FDA compliance. The first is experience. A...

The analytical data package defines the characteristics and structure of the therapeutic medical products and proves the safety,...

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...