Standard Operating Procedure for Preparing Batch Packaging Records (BPR)
1) Purpose
The purpose of this SOP is to establish a procedure for the preparation of Batch Packaging Records (BPR) to ensure accurate documentation of the packaging process.
2) Scope
This SOP applies to all personnel involved in the preparation, review, and approval of BPRs within the manufacturing facility.
3) Responsibilities
The responsibilities for this SOP are divided among various roles:
3.1 Packaging Personnel:
Responsible for accurately recording packaging data in the BPR.
3.2 Quality Assurance (QA) Personnel:
Responsible for reviewing and approving BPRs to ensure compliance with GMP standards.
4) Procedure
4.1 Preparation of BPR:
4.1.1 Use a standardized BPR template approved by the QA department.
4.1.2 Include all necessary information such as batch number, date of packaging, and product name.
4.1.3 Record each step of the packaging process in detail, including equipment used, materials used, and process parameters.
4.1.4 Document any deviations or anomalies observed during packaging.
4.2 Review and Approval:
4.2.1 Submit the completed BPR to the QA department for review.
4.2.2 QA personnel must verify the accuracy and completeness of the BPR.
4.2.3 Address any discrepancies or missing information before final approval.
4.2.4 Approve the BPR for release only after ensuring all data is accurate and complete.
4.3 Archiving:
4.3.1 Store approved BPRs in a secure and easily retrievable location.
4.3.2 Maintain BPRs for the required retention period as specified by regulatory guidelines.
4.3.3 Ensure that BPRs are accessible for audits and inspections.
5) Abbreviations, if any
BPR – Batch Packaging Record
QA – Quality Assurance
GMP – Good Manufacturing Practices
6) Documents, if any
1. BPR Template
2. Approved BPRs
3. Review and Approval Logs
7) Reference, if any
1. FDA Guidance on Good Manufacturing Practices (GMP)
2. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
8) SOP Version
Version 1.0
