FDA BRIEF: Week of April 25, 2016
- Best practices on how to improve the drug product and container closure design
- Examples that have resulted in postmarketing medication errors
- Minimize errors by proactive risk assessments and addressing risks before marketing
CONSIDERATIONS AT EARLY STAGE OF DRUG PRODUCT DESIGN TO MINIMIZE MEDICATION ERRORS : End Users and Environments of Use, Drug Product-User Interface
PROACTIVE RISK ASSESSMENTS: Failure Mode and Effects Analysis, Simulated Use Testing
- For regulatory evaluation of a digital whole slide imaging (WSI) system
- Several recent technological advances in digital microscopy
- Need understanding of technical performance of WSI system and components to design appropriate non-technical analytical and clinical studies
- Guidance provides recommendations for assessment of WSI technical characteristics
-Description and Test Methods for Each Component
-System-level Assessment
-User Interface
-Labeling
-Quality Control
- Increased observation of CGMP violations involving data integrity- compromising industry’s responsibility to ensure safety, efficacy, quality of drugs
- Guidance provides Agency’s current thinking on creation and handling of data in accordance CGMP
- Allows for flexible, risk-based strategies to prevent and detect data integrity issues
- Guidance outlines scope and application of21CFRpart 11 pending FDA’s reexamination of part 11
- Clarification provided on : “data integrity”, “metadata”, “audit trail”, “static” and “dynamic” record formats, “backup”
- Several other Q&As provided