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