Reviewing and Approving Batch Records in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for reviewing and approving batch records during the formulation development process, ensuring accuracy, completeness, and compliance with approved procedures and regulatory requirements.

2) Scope

This SOP applies to all formulation development projects within the organization, covering batch record review and approval activities from initial review to final approval.

3) Responsibilities

The responsibilities for this SOP include:
Quality Assurance: Overseeing batch record review and approval processes to ensure compliance with Good Manufacturing Practices (GMP) and internal procedures.
Production Supervisor: Documenting manufacturing activities accurately and preparing batch records for review.
Project Manager: Monitoring batch record review timelines and ensuring timely approval.
Regulatory Affairs: Ensuring batch records meet regulatory requirements and supporting submissions.

4) Procedure

4.1 Initial Review of Batch Records

1. Receive completed batch records from the production team after manufacturing activities are concluded.
2. Verify completeness of batch records, including all required sections and signatures.
3. Check for accuracy of documented information, including batch numbers, dates, materials used, and process parameters.

4.2 Compliance Review

1. Ensure batch records comply with approved Standard Operating Procedures (SOPs), specifications, and regulatory requirements.
2. Verify that critical process parameters (CPPs) and in-process controls are documented and within acceptable limits.
3. Identify any deviations or discrepancies in the batch records and initiate investigations as necessary.

4.3 Batch Record Approval

1. Review findings and recommendations from the compliance review.
2. Approve batch records if all requirements are met and there are no unresolved issues.
3. Sign and date approved batch records to indicate completion of review and approval process.

4.4 Documentation and Archiving

1. Document batch record review findings, including any identified deviations and corrective actions taken.
2. File approved batch records in a secure and organized manner according to document management procedures.
3. Maintain batch record archives for a defined retention period as per regulatory requirements.

4.5 Batch Record Rejection or Return for Correction

1. If batch records do not meet requirements, reject or return them to the production team for correction.
2. Provide clear feedback and instructions for corrections needed.
3. Ensure timely re-submission and re-review of corrected batch records.

5) Abbreviations, if any

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practices
CPPs: Critical Process Parameters

6) Documents, if any

Completed Batch Records
Batch Record Review Findings
Deviation Reports
Approval Records

7) Reference, if any

– ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
– FDA Guidance for Industry: Batch Production Records – Content and Review

8) SOP Version

Version 1.0