Standard Operating Procedure for Batch Record Documentation in Ointment Formulation

1) Purpose

The purpose of this SOP is to outline the procedures for the preparation, review, and maintenance of batch records for ointment formulation to ensure product quality and regulatory compliance.

2) Scope

This SOP applies to all personnel involved in the preparation, review, and maintenance of batch records for ointment formulation. It covers procedures from the creation of batch records to their storage and retrieval.

3) Responsibilities

– Production Staff: Responsible for accurately completing batch records during the formulation process.
– Quality Assurance (QA): Responsible for reviewing and approving batch records, and ensuring compliance with regulatory requirements.
– Document Control: Responsible for maintaining batch records and ensuring their accessibility and integrity.

4) Procedure

1. Preparation of Batch Records:
1.1 Batch Record Template:
1.1.1 Use the approved batch record template for each product.
1.1.2 Ensure the template includes all required sections (e.g., material quantities, process steps, signatures).
1.2 Record Completion:
1.2.1 Record all required information in real-time during production.
1.2.2 Ensure entries are legible, accurate, and complete.
1.2.3 Correct any errors by striking through with a single line, initialing, and dating the correction.

Review and Approval of Batch Records:
2.1 Initial Review:
2.1.1 Conduct an initial review of the completed batch record for accuracy and completeness.
2.1.2 Address any discrepancies or incomplete entries.

2.2 QA Review:
2.2.1 QA reviews the batch record to ensure compliance with SOPs and regulatory standards.
2.2.2 Approve or reject the batch record based on the review.

Maintenance and Storage of Batch Records:
3.1 Document Control:
3.1.1 Store approved batch records in a secure, controlled environment.
3.1.2 Maintain batch records for the required retention period as specified by regulatory guidelines.

3.2 Accessibility:
3.2.1 Ensure batch records are easily retrievable for audits and inspections.
3.2.2 Implement a tracking system for batch record retrieval.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents, if any

– Batch Record Templates
– Completed Batch Records
– Review and Approval Logs

7) Reference, if any

– FDA Current Good Manufacturing Practice (CGMP) Regulations
– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

8) SOP Version

Version 1.0