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A GLANCE AT DATA INTEGRITY
A GLANCE AT DATA INTEGRITY Data Integrity is a cornerstone of the Quality Culture. The specific culture of an organization is connected...
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- 10 min
Investigating Out-of-Specification (OOS)
Test Results for Pharmaceutical Production Guidance for Industry (May 2022)
- 2 min
Benefit-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 min
FDA announces draft guidance on Benefit-Risk Considerations for Product Quality Assessments
Today, FDA announced the availability of a draft guidance for industry, Benefit-Risk Considerations for Product Quality Assessments. This...
- 2 min
The Importance of a Good Consulting Firm in FDA Compliance
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...
- 2 min
Successful 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 min
An Approach to Cleaning And Cross-Contamination
There is a considerable effort from some Pharmaceutical Companies into addressing cleaning issues and possible cross-contamination,...
- 1 min
Data Integrity
FDA statistics, over the years (2014-2019) identified the Data Integrity (DI) events as the most cited on the Warning Letter. The year...
- 1 min
Get your Free Draft Guidance
"Microbiological Quality Considerations in Non-sterile Drug Manufacturing" Firms must have a microbial control strategy by establishing a...
- 2 min
Controlling 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 min
FDA Requirements
Regulatory Requirements Regulatory issues are involved in nearly every aspect of vaccine development, manufacturing, and marketing...