Standard Operating Procedure for Batch Record Review in Transdermal Patches Production

1) Purpose

The purpose of this SOP is to establish procedures for the review and approval of batch records generated during the production of transdermal patches to ensure compliance with established protocols and regulatory requirements.

2) Scope

This SOP applies to the review process of batch records for all batches of transdermal patches manufactured within the facility.

3) Responsibilities

The Quality Assurance (QA) Department is responsible for conducting batch record review as per this SOP. Production personnel are responsible for timely submission of completed batch records.

4) Procedure

4.1 Receipt and Initial Check

• 4.1.1 Upon receipt of batch records, verify completeness and accuracy of all required documents, including production logs, in-process testing results, and packaging records.
• 4.1.2 Ensure batch records are legible, signed, and dated by authorized personnel at each stage of production.

4.2 Compliance Review

• 4.2.1 Review batch records to ensure compliance with approved master batch records (MBRs), standard operating procedures (SOPs), and regulatory requirements.
• 4.2.2 Verify that all critical process parameters and specifications have been recorded and meet predefined acceptance criteria.

4.3 Deviation and Non-Conformance Evaluation

• 4.3.1 Identify any deviations or non-conformances noted during production and ensure appropriate investigation and documentation according to deviation handling procedures.
• 4.3.2 Assess the impact of deviations on product quality and compliance and determine the need for corrective and preventive actions (CAPA).

4.4 Documentation Review

• 4.4.1 Verify completeness of documentation related to equipment calibration, cleaning, and maintenance activities performed during batch production.
• 4.4.2 Cross-check batch records with associated documentation, including raw material certificates of analysis (CoA) and packaging component specifications.

4.5 Final Approval and Release

• 4.5.1 Approve batch records for final review by authorized QA personnel based on thorough review and compliance assessment.
• 4.5.2 Authorize the release of finished batches for further processing, packaging, or distribution upon completion of batch record review.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
MBR: Master Batch Record
CoA: Certificate of Analysis
CAPA: Corrective and Preventive Actions

6) Documents, if any

Master Batch Records
Deviation Investigation Reports
Batch Production Logs

7) Reference, if any

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals

8) SOP Version

Version 1.0