📘 Preparation of Batch Packaging Record (BPR)

A Batch Packaging Record (BPR) is a controlled document that provides a detailed account of the packaging process for a specific batch of a pharmaceutical product. It ensures traceability, compliance with GMP, and consistency in product quality.

Steps for Preparation of BPR

1. Basic Information Section

   • Product name, strength, dosage form

   • Batch number, lot number, and manufacturing date

   • Expiry date and shelf life

   • Reference to the corresponding Master Packaging Record (MPR)

2. Packaging Material Details

   • Description and code of all packaging components (e.g., labels, cartons, leaflets, bottles, blisters, caps, foils)

   • Approved suppliers and status of materials (QC released)

   • Quantity issued and returned

3. Line Clearance and Equipment Checks

   • Line clearance from QA before start of packaging

   • Equipment cleaning and status labels

   • Environmental conditions (where applicable)

4. Packaging Process Instructions

   • Step-wise procedure for packaging (primary and secondary)

   • In-process checks (e.g., print quality, batch coding, sealing integrity, weight/volume checks)

   • Reconciliation of packaging materials

5. Yield Calculation

   • Expected yield vs. actual yield

   • Reconciliation of packed units vs. rejected/damaged units

6. In-Process Quality Control (IPQC) Records

   • Sampling and results of critical parameters

   • Deviations, if any, with justification and approval

7. Final Approval and Release

   • Review by Production and QA

   • QA certification for batch release

✅ Importance of BPR

• Ensures GMP compliance

• Provides traceability and accountability

• Supports deviation/investigation if issues arise

• Ensures accurate reconciliation of materials

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