PDF Edition - Mastering Batch Record Review

October 2009
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Batch record review is a necessary but thankless task. Many drug manufacturers fob it off on the least trained, most junior QA/review staffers ... but that’s a mistake. Failure to comply with FDA batch record review processes is among the Top Ten most frequent deficiencies cited during agency inspections of drug and biologics manufacturers.

Why risk a Form 483 or warning letter when it’s so easy to do batch record reviews right?

This management report from FDAnews covers what you and your staff need to know about batch record review, from an overview of the basics to advanced techniques for seasoned quality veterans. Read and understand:

  • Batch record review requirements of both the FDA and EU authorities
  • What must be included in a batch review record
  • Which review elements must be performed by QA/QC professionals and which may be delegated
  • How to speed batch record review without sacrificing quality
  • How to measure the effectiveness of the review process
  • When and how to tie batch record review with CAPA
  • And more!

Chapter List

  • Introduction
  • Batch Record Review Regulatory Overview
  • Resources for Effective Batch Record Review
  • How to Handle Errors, Corrections, Deviations, Investigations and CAPA
  • Metrics of the Batch Record Review Process
  • FAQs
  • Conclusion
  • Appendices

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