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 creation, review, approval, distribution, retention, and archiving of batch records within the pharmaceutical manufacturing facility to ensure compliance with regulatory requirements and product traceability.
2) Scope
This SOP applies to all batch records generated during the manufacturing, packaging, labeling, and testing of pharmaceutical products. It covers procedures for batch record creation, revision control, review, approval, and archival.
3) Responsibilities
– Quality Assurance (QA) Department: Oversees batch record management and ensures compliance with SOP and regulatory requirements.
– Production Department: Creates and maintains accurate batch records in accordance with approved procedures.
– Quality Control (QC) Department: Reviews batch records for completeness, accuracy, and compliance before product release.
4) Procedure
4.1 Batch Record Creation
4.1.1 Develop batch records using approved templates and formats that include all necessary information for product manufacturing and testing.
4.1.2 Assign unique batch numbers and version identifiers to each batch record for traceability.
4.2 Batch Record Review and Approval
4.2.1 Conduct initial review of batch records by relevant personnel (e.g., Production, QC) to verify completeness and accuracy.
4.2.2 Obtain approvals from designated personnel (e.g., QA,
4.3 Batch Record Distribution
4.3.1 Distribute approved batch records to relevant departments (e.g., Production, QC) for execution of manufacturing and testing activities.
4.3.2 Maintain records of batch record distribution and acknowledge receipt from recipients.
4.4 Batch Record Retention
4.4.1 Retain batch records in a secure and controlled environment throughout the product lifecycle as per regulatory requirements.
4.4.2 Establish retention periods based on product stability, regulatory guidelines, and potential for post-market issues.
4.5 Batch Record Archiving
4.5.1 Archive completed batch records in a secure, organized manner to ensure integrity and accessibility for regulatory inspections and audits.
4.5.2 Label archived batch records with batch numbers, version identifiers, and archival dates for easy retrieval and traceability.
4.6 Batch Record Retrieval
4.6.1 Establish procedures for the retrieval of archived batch records in response to regulatory inspections, product investigations, or customer complaints.
4.6.2 Ensure that retrieved batch records are handled by authorized personnel and returned to archival storage after use.
4.7 Batch Record Disposition
4.7.1 Define procedures for the disposal or destruction of obsolete or expired batch records in compliance with regulatory requirements.
4.7.2 Document and justify decisions regarding batch record disposition, including approvals from relevant stakeholders.
4.8 Documentation
4.8.1 Maintain comprehensive records of batch record creation, review, approval, distribution, retention, archiving, retrieval, and disposition activities.
4.8.2 Ensure that all records are legible, accurate, and readily accessible for review by regulatory authorities.
4.9 Reporting
4.9.1 Prepare periodic reports summarizing batch record management activities, including compliance status, issues identified, and corrective actions taken.
4.9.2 Submit reports to the QA department for review, approval, and archiving.
5) Abbreviations, if any
– QA: Quality Assurance
– SOP: Standard Operating Procedure
– QC: Quality Control
6) Documents, if any
– Batch Records (for each batch manufactured)
– Batch Record Archival Log
– Batch Record Disposition Records
7) Reference, if any
– FDA Guidance for Industry: Batch Record Review and Investigation of Critical Deviations
– EudraLex Volume 4: Good Manufacturing Practice (GMP) Guidelines
8) SOP Version
Version 1.0