1. Introduction – Batch Packing Record for Ibuprofen & Paracetamol Tablets IP:
The Batch Packing Record (BPR) for Ibuprofen & Paracetamol Tablets IP is a controlled pharmaceutical document designed to provide complete, traceable, and documented evidence of all activities performed during the packing of the finished tablet product. The product contains Ibuprofen IP 400 mg and Paracetamol IP 325 mg per uncoated tablet, with specified storage conditions of below 30°C and protection from light and moisture. This BPR provides a systematic framework for recording the receipt and transfer of inspected tablets, dispensing of packaging materials, overprinting details, line clearance, machine setup, packing operations, and in-process checks. It also incorporates verification of sealing and forming temperatures, leak testing, environmental conditions, carton and shipper fill quantities, and routine packing-line inspections to ensure consistency and compliance throughout the operation. The document further ensures appropriate reconciliation of packaging materials, recording and analysis of rejected materials, destruction of rejected or obsolete components, yield calculation, finished-goods transfer, and final verification by Production and Quality Assurance. Proper completion of this BPR supports GMP compliance, product identification, prevention of mix-ups, packaging integrity, accountability of materials, batch traceability, and documented quality assurance before release of the finished product.
Skip to PDF content1. Flow Diagram – Batch Packing Record for Ibuprofen & Paracetamol Tablets IP:
The Batch Packing Record for Ibuprofen & Paracetamol Tablets IP describes the complete sequence of packing activities required to ensure proper identification, control, traceability, and reconciliation of the finished product. The process begins with receipt of inspected tablets from the manufacturing section and recording the packing schedule. Packaging materials such as blister foil, PVC, cartons, and shippers are dispensed and verified before use.
Overprinting details are checked for correctness, followed by line clearance of the overprinting and packing areas to confirm that previous product materials are removed and equipment is clean. The packing line is then set with defined operating parameters such as sealing temperature, forming temperature, leak testing, environmental conditions, and packing quantities. During operation, in-process checks are performed at specified intervals to verify packing quality and fill quantities. Finally, packaging materials are reconciled, rejected materials are recorded and analyzed, yield is calculated, finished goods are transferred, and the completed batch record is verified and approved by Production and Quality Assurance.
3. Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) for Ibuprofen & Paracetamol Tablets IP:
The CPP and CQA for the Batch Packing Record of Ibuprofen & Paracetamol Tablets IP are established to ensure that the packing process remains controlled and that the finished packed product consistently meets defined quality requirements. Critical Process Parameters include sealing temperature, forming temperature, machine speed, packaging material quality, environmental conditions, machine setup, and line clearance. These parameters directly influence blister formation, seal integrity, packing accuracy, and prevention of mix-ups. The BPR specifically requires monitoring of sealing and forming temperatures, machine speed, leak testing, temperature, relative humidity, and packing quantities during line setup and in-process operation.
Critical Quality Attributes include appearance and print clarity, sealing integrity, correct tablet count, approved packaging material quality, proper cartoning and shipper packing, and product identification and traceability. The record also requires verification of batch number, manufacturing date, expiry date, price, and other overprinting details on blisters, cartons, and shippers. Effective monitoring of these CPPs and CQAs helps maintain packaging integrity, correct labeling, accurate fill quantity, traceability, and overall GMP compliance throughout the packing operation.