Batch Record Review and Investigations

Industry field:

Pharmaceutical industry, Final dosage form

Course description:

This course concentrates on the practical applications of GMPs and FDA compliance requirements, from the batch record review process to final batch disposition. The course begins with practical instructions and techniques for conducting a technical batch record review and identifying batch related discrepancies. The identification of batch record discrepancies is followed with a discussion on the differentiation between incidents that can be addressed with an explanation in the batch record versus those that require the filing of a deviation and the performance of an investigation. The course then shifts to the procedures for performing a follow-up investigation of deviations, 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 drug products.

Course outline:

Day 1

• 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 and Batch Disposition

• Review Examples of Investigations

Day 2:

• Review Examples of Investigations

       - 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

• Class Workshop: Batch Record Review

       - Recognition of batch record discrepancies and GMP

        compliance deficiencies

       - Identifying the potential causes for the follow-up investigation

Day 3

• Preparing the Investigation Report

• Class Workshop: Conducting an Investigation

       - Investigating LAL failure in water-for-injection system

       - Investigating content uniformity failure

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 batch record documentation and 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 facts

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