Standard Operating Procedure for Batch Record Preparation and Review in Otic Manufacturing Unit

1) Purpose

To establish guidelines for the preparation, completion, and review of batch records for Otic (Ear) Dosage Forms to ensure accuracy, completeness, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the preparation, completion, and review of batch records within the Otic manufacturing facility.

3) Responsibilities

Production Supervisors: Responsible for overseeing batch record preparation and completion.
Quality Assurance (QA) Department: Responsible for reviewing and approving batch records.
Documentation Control: Responsible for maintaining batch record templates and ensuring document control.

4) Procedure

4.1 Batch Record Preparation
4.1.1 Document Control
4.1.1.1 Retrieve the master batch record template from the document control system.
4.1.1.2 Verify the template version and ensure it matches the current manufacturing order.

4.1.2 Recording Information
4.1.2.1 Enter required information into the batch record template, including batch number, product name, date, and manufacturing instructions.
4.1.2.2 Record details of raw materials used, equipment used, and in-process checks.

4.2 Batch Record Completion
4.2.1 Real-time Documentation
4.2.1.1 Complete batch records accurately and in real-time during the manufacturing process.
4.2.1.2 Initial and date each page of the batch record as activities are performed.

4.2.2 In-process Checks
4.2.2.1 Perform in-process checks as specified in the batch record and document results.
4.2.2.2 Record any deviations encountered during manufacturing.

4.3 Batch Record Review
4.3.1 Initial Review
4.3.1.1 Conduct an initial review of the completed batch record for accuracy and completeness.
4.3.1.2 Verify that all required signatures and approvals are obtained.

4.3.2 QA Review
4.3.2.1 Submit the batch record to QA for review and approval.
4.3.2.2 QA verifies compliance with GMP and batch record instructions.

4.4 Documentation and Archiving
4.4.1 Archival
4.4.1.1 Archive completed and approved batch records according to the document retention policy.
4.4.1.2 Ensure batch records are stored securely and are readily retrievable for inspection.

4.4.2 Recordkeeping
4.4.2.1 Maintain batch record logs to track the status of each batch record.
4.4.2.2 Update the electronic batch record management system with batch record completion and approval.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
GMP: Good Manufacturing Practices

6) Documents, if any

Master batch record template
Batch record logs
Document control procedures

7) Reference, if any

GMP guidelines for batch record preparation and review in pharmaceutical manufacturing

8) SOP Version

Version 1.0