Standard Operating Procedure for Batch Documentation for FFS Operations

1) Purpose

The purpose of this SOP is to establish guidelines for the preparation, review, and maintenance of batch documentation related to Form-Fill-Seal (FFS) operations in pharmaceutical manufacturing.

2) Scope

This SOP applies to all batch documentation activities for FFS operations within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Production Supervisor

• Ensure accurate and timely preparation of batch documentation.
• Review and approve batch records before production starts.

3.2 Quality Assurance (QA) Personnel

• Verify completeness and compliance of batch documentation with regulatory requirements.
• Conduct batch record review and reconciliation.

4) Procedure

4.1 Batch Record Preparation

1. Generate batch records based on approved master production documents.
2. Include all necessary details such as product specifications, process parameters, and packaging instructions.

4.2 Review and Approval

1. Review batch records for completeness and accuracy.
2. Obtain approval from authorized personnel before production commences.

4.3 Documentation Control

1. Assign unique batch numbers and document all changes or deviations during production.
2. Maintain version control and ensure all records are legible, accurate, and traceable.

4.4 Archiving and Retrieval

1. Archive batch documentation in designated storage areas as per retention policies.
2. Facilitate timely retrieval of batch records for internal audits or regulatory inspections.

5) Abbreviations, if any

FFS: Form-Fill-Seal
QA: Quality Assurance

6) Documents, if any

• Batch Records
• Change Control Logs
• Archival and Retrieval Procedures

7) Reference, if any

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

8) SOP Version

Version 1.0