1. Introduction – Batch Packing Record of Paracetamol & Aceclofenac Tablets:
The Standard Operating Procedure (SOP) for Batch Packing Record (BPR) of Paracetamol & Aceclofenac Tablets provides a systematic and documented approach for performing, monitoring, verifying, and recording pharmaceutical packaging operations in accordance with Good Manufacturing Practices (GMP). The primary objective is to ensure that every batch is packed under controlled conditions, maintaining product identity, quality, integrity, traceability, and compliance with established packaging specifications. Paracetamol & Aceclofenac Tablets are film-coated tablets containing Paracetamol IP 325 mg and Aceclofenac IP 100 mg. As specified in the Batch Packing Record, the product is packed in 20 × 10 Alu-Alu packaging, providing protection against environmental factors such as moisture and light. The prescribed storage condition is below 30°C, protected from light and moisture. The Batch Packing Record covers the complete packaging sequence, including the receipt of inspected tablets from the manufacturing department, packaging material dispensing, overprinting verification, equipment cleaning, line clearance, machine setup, primary packaging, secondary packaging, and finished product transfer. Special attention is given to Critical Process Parameters (CPPs) such as sealing roller temperature, forming roller temperature, machine speed, and packaging integrity. In-process quality checks include leak testing, overprinting verification, carton filling quantity, shipper filling quantity, and monitoring of environmental conditions. The record specifies leak testing at the beginning of operations, during foil changes, and every two hours. It also includes periodic checks to prevent packaging defects, incorrect labeling, product mix-ups, and quantity discrepancies. Furthermore, the BPR incorporates packaging material reconciliation, rejection analysis, destruction records, yield calculations, and final verification by authorized Production and Quality Assurance personnel. Proper implementation of this procedure supports data integrity, batch traceability, packaging consistency, deviation control, and regulatory compliance. It also provides documented evidence that packaging activities have been performed and verified according to approved procedures.
Skip to PDF content2. Paracetamol & Aceclofenac Tablets – Flow Diagram:
The flow diagram illustrates the systematic sequence of operations involved in the Batch Packing Record (BPR) of Paracetamol & Aceclofenac Tablets, ensuring compliance with Good Manufacturing Practices (GMP) and established packaging procedures. The process begins with the receipt of inspected tablets from the manufacturing department, followed by dispensing and verification of approved packaging materials. Equipment cleaning and line clearance are performed to prevent contamination, product mix-ups, and packaging errors.
After line clearance, the packaging machine is set up by verifying critical operating parameters, including forming temperature, sealing temperature, and machine speed. Tablets are packed using Alu-Alu blister packaging, followed by in-process quality checks such as leak testing, overprinting verification, and packaging integrity inspection. Accepted blisters undergo secondary packaging into cartons, followed by shipper packing. Rejected materials are recorded and handled according to approved procedures. Finally, packaging material reconciliation, rejection analysis, yield calculation, and finished goods transfer are documented. Production and Quality Assurance personnel verify the records to ensure product quality, traceability, packaging accuracy, and GMP compliance.
3. Batch Packing Record (BPR) of Paracetamol & Aceclofenac Tablets – Critical Process Parameters (CPP) and Critical Quality Attributes (CQA):
The Batch Packing Record of Paracetamol & Aceclofenac Tablets emphasizes the monitoring and control of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) to ensure consistent packaging quality, product protection, and compliance with Good Manufacturing Practices (GMP). Critical Process Parameters (CPPs) include forming roller temperature, sealing roller temperature, machine speed, packaging material specifications, and operating conditions. Proper control of these parameters helps achieve uniform blister formation, effective sealing, and prevention of packaging defects. The Batch Packing Record specifies monitoring environmental temperature, relative humidity, and leak testing at the beginning of operations, during foil changes, and every two hours.
Critical Quality Attributes (CQAs) for packaging include blister seal integrity, correct tablet count, accurate overprinting, intact tablets, appropriate packaging material quality, and correct carton and shipper labeling. In-process inspections verify batch numbers, manufacturing and expiry dates, packaging appearance, and fill quantities to prevent product mix-ups and labeling errorsThe procedure also includes rejection analysis, packaging material reconciliation, yield calculations, and documentation review by Production and Quality Assurance personnel.Effective monitoring of these parameters supports product stability, packaging integrity, batch traceability, patient safety, and regulatory compliance.
Note: CPP and CQA classifications should be confirmed through approved process validation and quality risk assessment documents.