Preparing Batch Records in Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for preparing batch records during the formulation development process, ensuring accurate documentation of manufacturing activities and compliance with regulatory requirements.

2) Scope

This SOP applies to all formulation development projects within the organization, covering batch record preparation activities from initial planning to final batch release.

3) Responsibilities

The responsibilities for this SOP include:
Project Manager: Overseeing batch record preparation and ensuring adherence to project timelines and regulatory standards.
Production Team: Documenting manufacturing activities and completing batch records accurately.
Quality Assurance: Reviewing and approving batch records for completeness, accuracy, and compliance.
Regulatory Affairs: Ensuring batch records meet regulatory requirements and supporting submissions.

4) Procedure

4.1 Batch Record Planning

1. Define batch record requirements based on approved manufacturing processes and specifications.
2. Prepare batch record templates or forms that include sections for critical process parameters (CPPs), in-process controls, and quality checks.
3. Obtain approval for batch record templates from quality assurance and stakeholders.

4.2 Batch Record Preparation

1. Document manufacturing activities in real-time during production, including equipment usage, raw materials used, and process parameters.
2. Record in-process test results, environmental conditions, and any deviations encountered during manufacturing.
3. Complete batch records promptly after manufacturing activities are concluded.

4.3 Batch Record Review and Approval

1. Review completed batch records for accuracy, completeness, and compliance with approved procedures.
2. Perform reconciliation of batch records to ensure all materials and activities are accounted for.
3. Obtain approval from designated approvers (e.g., production supervisor, quality assurance).

4.4 Batch Record Filing and Storage

1. File approved batch records in a secure and organized manner according to document management procedures.
2. Maintain batch record archives for a defined retention period as per regulatory requirements.
3. Ensure batch records are readily accessible for review, audits, and regulatory inspections.

4.5 Batch Record Corrections and Amendments

1. Document any corrections or amendments to batch records using approved procedures and forms.
2. Obtain authorization and approval for corrections from quality assurance or designated personnel.
3. Ensure all corrections are documented, justified, and traceable.

5) Abbreviations, if any

SOP: Standard Operating Procedure
CPPs: Critical Process Parameters

6) Documents, if any

Batch Record Templates
Completed Batch Records
Batch Record Reconciliation Reports
Batch Record Amendment Forms

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