2 minA GLANCE AT DATA INTEGRITYA GLANCE AT DATA INTEGRITY Data Integrity is a cornerstone of the Quality Culture. The specific culture of an organization is connected...
10 minInvestigating Out-of-Specification (OOS)Test Results for Pharmaceutical Production Guidance for Industry (May 2022)
2 minBenefit-Risk Considerations for Product Quality (B-RCPQ)Assessments Guidance for Industry dated May 2022) General Comments Comments and suggestions regarding this draft document should be...
1 minFDA announces draft guidance on Benefit-Risk Considerations for Product Quality AssessmentsToday, FDA announced the availability of a draft guidance for industry, Benefit-Risk Considerations for Product Quality Assessments. This...
2 minThe Importance of a Good Consulting Firm in FDA ComplianceThere 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...
2 minSuccessful Regulatory Approval of Medical Products Depends on Robust Product Characterization. The analytical data package defines the characteristics and structure of the therapeutic medical products and proves the safety,...
1 minAn Approach to Cleaning And Cross-ContaminationThere is a considerable effort from some Pharmaceutical Companies into addressing cleaning issues and possible cross-contamination,...
1 minData IntegrityFDA statistics, over the years (2014-2019) identified the Data Integrity (DI) events as the most cited on the Warning Letter. The year...
1 minGet your Free Draft Guidance"Microbiological Quality Considerations in Non-sterile Drug Manufacturing" Firms must have a microbial control strategy by establishing a...
2 minControlling the Microbiological Quality of Non-sterile Drugs. Applying risk assessment tools to determine the adequate Microbial testing for non-sterile finished drug products. A few days back, FDA...
3 minFDA RequirementsRegulatory Requirements Regulatory issues are involved in nearly every aspect of vaccine development, manufacturing, and marketing...