Standard Operating Procedure for Batch Production Record (BPR) Preparation in Ointment Formulation

1) Purpose

The purpose of this SOP is to establish the procedures for preparing Batch Production Records (BPRs) for ointment formulation to ensure consistency, traceability, and regulatory compliance.

2) Scope

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

3) Responsibilities

– Production Staff: Responsible for completing BPRs during the manufacturing process.
– Quality Assurance (QA): Responsible for reviewing and approving BPRs, and ensuring compliance with regulatory standards.
– Document Control: Responsible for maintaining BPRs and ensuring their accessibility.

4) Procedure

1. Preparation of BPR:
1.1 BPR Template:
1.1.1 Use the approved BPR template for each product.
1.1.2 Ensure the template includes sections for raw materials, equipment, process steps, in-process controls, and quality control tests.
1.2 Data Entry:
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 BPR:
2.1 Initial Review:
2.1.1 Conduct an initial review of the completed BPR for accuracy and completeness.
2.1.2 Address any discrepancies or incomplete entries.

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

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

3.2 Accessibility:
3.2.1 Ensure BPRs are easily retrievable for audits and inspections.
3.2.2 Implement a tracking system for BPR retrieval.

5) Abbreviations, if any

– BPR: Batch Production Record
– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents, if any

– BPR Templates
– Completed BPRs
– 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