S-02. Batch Record Review and Investigations

Course Description

This course concentrates on the practical applications of GMP 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 discrepancies noted from batch production and testing and 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.

Learning Objectives

This course will teach the attendees how to perform a technical review of batch records to detect hidden compliance and quality problems. They will also acquire the skills to conduct the appropriate follow-up investigation and make the final decision or recommendations.

Who Should Attend

This course is intended for Production, Quality Assurance and Compliance personnel who are responsible for making batch record entries and performing reviews and compliance investigations. This course is suitable for both entry-level batch record reviewers and compliance personnel, as well as advanced-level personnel, including supervisors and managers.

Course Outline

  • GMP Requirements for Batch Records
  • Recommendations for Reviewing Batch Records
  • Variance/Deviation/Non-Conformity Systems
  • 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
  • Preparing the Investigation Report
  • Class Workshop: Variance/Deviation/Non-conformity Classification
    • When to classify and document an “event” as a Deviation/Variance/Non-conformity
  • Class Workshop: Batch Record Review
    • Recognizing batch record discrepancies and GMP compliance deficiencies
    • Identifying the potential causes for the follow-up investigation