Standard Operating Procedure for Managing and Archiving Batch Records
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish procedures for the management, review, approval, and archival of batch records generated during pharmaceutical manufacturing processes to ensure compliance with regulatory requirements and product quality standards.
2) Scope
This SOP applies to the creation, maintenance, review, approval, and archival of batch records for all pharmaceutical products manufactured within the facility.
3) Responsibilities
– Production Supervisor: Oversees the preparation and completion of batch records during manufacturing operations.
– Quality Assurance (QA) Department: Reviews and approves batch records to ensure compliance with cGMP requirements and product specifications.
– Document Control Officer: Manages the distribution, retrieval, and archival of batch records in accordance with SOP and regulatory guidelines.
4) Procedure
4.1 Batch Record Preparation
4.1.1 Generate batch records based on approved master production documents, including batch production records (BPRs) and associated documentation.
4.1.2 Include all relevant information in batch records, such as batch number, manufacturing dates, equipment used, raw materials, in-process controls, and packaging details.
4.2 Batch Record Review and Approval
4.2.1 Review batch records for completeness, accuracy, and compliance with approved master production documents and SOPs.
4.2.2 Obtain approval of batch records
4.3 Batch Record Archival
4.3.1 Archive completed and approved batch records in a secure, controlled environment to prevent loss, damage, or unauthorized access.
4.3.2 Ensure batch records are stored according to predefined retention periods and archival procedures specified in SOP and regulatory requirements.
4.4 Batch Record Retrieval and Accessibility
4.4.1 Establish a documented procedure for retrieving batch records promptly upon request for review by regulatory authorities, internal audits, or product release activities.
4.4.2 Maintain an organized batch record index or database to facilitate efficient retrieval and traceability of archived batch records.
4.5 Batch Record Change Control
4.5.1 Implement a change control process for batch records to manage revisions, corrections, and amendments throughout the record lifecycle.
4.5.2 Document all changes to batch records, including reasons for change, approvals obtained, and effective dates of revisions.
4.6 Batch Record Destruction
4.6.1 Establish procedures for the secure and controlled destruction of batch records that have reached the end of their retention period or are no longer required.
4.6.2 Ensure batch record destruction activities are documented, authorized, and performed in accordance with SOP and regulatory guidelines.
4.7 Documentation
4.7.1 Maintain a comprehensive batch record log or inventory detailing the status, location, and retention period of all batch records.
4.7.2 Ensure all batch record-related documentation, including destruction certificates and change control records, is archived and accessible for regulatory inspections.
4.8 Reporting
4.8.1 Prepare periodic reports summarizing batch record management activities, including compliance status, archival activities, and any deviations or corrective actions implemented.
4.8.2 Submit reports to the QA department for review, approval, and archiving as per document control procedures.
5) Abbreviations, if any
– SOP: Standard Operating Procedure
– QA: Quality Assurance
– cGMP: Current Good Manufacturing Practice
– BPRs: Batch Production Records
6) Documents, if any
– Batch Production Records (BPRs)
– Batch Record Index
– Batch Record Change Control Forms
7) Reference, if any
– FDA Guidance for Industry: Batch Production Records and Control of Batch Production
– EU GMP Annex 1: Manufacture of Sterile Medicinal Products
– ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0
