FDA BRIEF: Week of April 25, 2016


fda guidances


safety

  • 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

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technical perf

  • 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

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data

 

  • 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

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