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