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FDA cGMP: Batch Record Review and Investigations

Date: To be confirmed
Instructor: Dr. Mel Dong
Location: To be confirmed
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This course concentrates on the practical applications of GMPs and FDA compliance requirements, from the batch record review process to final batch disposition. It begins with practical instructions and techniques for conducting a technical batch record review and identifying batch related discrepancies. The course then shifts to the follow-up investigation of common discrepancies noted from batch production and testing, the decision making process for the final disposition of the batch (i.e., release, reject or rework.)

The course lecture provides the attendees with technical knowledge and understanding of the compliance requirements, and "how-to" instructions for batch record review and follow-up investigations. This is achieved by focusing on the interpretation of the GMPs and FDA requirements, using FDA references, industry practices, FDA-483 citations and "real-life" experiences. The knowledge acquired from the lecture is, then, applied to class workshops to enhance the practical skills for conducting batch record reviews, identifying significant discrepancies, conducting the necessary follow-up investigations, and making the appropriate decision for batch disposition.

All topics and workshops in this course include examples for sterile and non-sterile products.

  • GMP Requirements for Batch Records
  • Recommendations for Reviewing Batch Records
  • Training Batch Record Reviewers
  • Technical Review of Analytical Data
  • Variance/Deviation Systems
  • Class Exercise: Deviation Classification
  • Compliance Requirements for Follow-up Investigations
  • Evaluation of Investigation Findings
  • Review Examples of Investigation
    • Laboratory out-of-specification test results
    • Dissolution test failure
    • Sterility test failure
    • Labeling and product reconciliation discrepancies
    • Labeling and product mix-ups
    • Compliance issues for product reprocessing/rework
  • Preparing the Investigation Report
  • Class Workshop: Batch Record Review
    • Recognition of batch record discrepancies and GMP compliance deficiencies
    • Identifying the potential causes for the follow-up investigation
  • Class Workshop: Conducting an Investigation
    • Investigating LAL failure in water-for-injection system
    • Investigating content uniformity failure