1. Introduction – BATCH PACKING RECORD (BPR) FOR PARACETAMOL & DICLOFENAC SODIUM TABLETS IP:
The Batch Packing Record (BPR) for Paracetamol & Diclofenac Sodium Tablets IP is a comprehensive Good Manufacturing Practice (GMP) documentation system designed to ensure the systematic execution, monitoring, verification, and recording of pharmaceutical packaging operations. It provides documented evidence that each batch is packed under controlled conditions in accordance with approved procedures, packaging specifications, and quality requirements. The product, Diclocit Plus Tablets, contains Paracetamol IP 325 mg and Diclofenac Sodium IP 50 mg in each uncoated tablet. The specified pack size is 25 × 2 × 10 (Clear), with storage conditions requiring temperatures below 30°C and protection from light and moisture.The BPR establishes a structured approach covering the receipt of inspected tablets from the manufacturing department, dispensing and verification of packaging materials, overprinting operations, equipment cleaning, line clearance, machine setup, and in-process quality checks. Critical packing parameters, including sealing roller temperature, forming roller temperature, machine speed, leak testing, environmental temperature, relative humidity, carton filling quantity, and shipper filling quantity, are documented to maintain packaging consistency and product integrity. The record also includes verification of batch numbers, manufacturing dates, expiry dates, maximum retail prices, printed foils, cartons, and shipper labels to prevent labeling errors, product mix-ups, and packaging discrepancies. Furthermore, the BPR provides formats for packaging material reconciliation, rejection analysis, destruction records, finished goods transfer, yield calculations, and final verification by authorized Production and Quality Assurance personnel. The primary objective of this BPR is to maintain complete batch traceability, ensure packaging accuracy, minimize operational errors, support regulatory compliance, and establish documented accountability throughout the packaging process. Effective implementation of the Batch Packing Record strengthens pharmaceutical quality assurance, facilitates batch review and release, and ensures that finished Paracetamol & Diclofenac Sodium Tablets are consistently packed according to approved specifications and established GMP requirements.
Skip to PDF content2. BATCH PACKING RECORD (BPR) FOR PARACETAMOL & DICLOFENAC SODIUM TABLETS IP – FLOW DIAGRAM:
The flow diagram illustrates the systematic sequence of packing operations for Paracetamol 325 mg and Diclofenac Sodium 50 mg Tablets IP (Diclocit Plus Tablets) in accordance with the approved Batch Packing Record (BPR) and Good Manufacturing Practices (GMP). The process begins with the receipt and verification of inspected tablets from the manufacturing department, followed by dispensing and checking of approved packaging materials. Equipment cleaning, machine setup, and line clearance are performed before initiating packing operations to prevent product mix-ups and cross-contamination. Primary packaging involves blister or strip packing, with monitoring of sealing temperature, machine speed, leak test results, and printed information. Secondary packaging includes carton filling, labeling verification, and quantity checks, followed by tertiary packaging into properly identified shippers.
Throughout the process, in-process quality checks verify packaging integrity, batch details, manufacturing and expiry dates, and correct packing quantities. Finally, packaging material reconciliation, rejection analysis, yield calculations, and BPR documentation review are completed. Finished goods are transferred to the designated storage area under the applicable Quality Assurance release controls. The flow diagram emphasizes process control, traceability, packaging accuracy, and GMP compliance throughout the batch packing operation.
3. BATCH PACKING RECORD (BPR) FOR PARACETAMOL & DICLOFENAC SODIUM TABLETS IP – CPP AND CQA:
The Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) for Paracetamol 325 mg and Diclofenac Sodium 50 mg Tablets IP (Diclocit Plus Tablets) play an important role in maintaining product quality, packaging integrity, and compliance with Good Manufacturing Practices (GMP). The key packing process parameters include sealing roller temperature, forming roller temperature, machine speed, environmental temperature, relative humidity, and correct machine setup. These parameters must be monitored and controlled according to approved packaging specifications to prevent defective seals, damaged blisters, and product deterioration. Additional controls include equipment cleaning, line clearance, overprinting verification, carton filling, shipper packing, and periodic leak testing. The BPR specifies leak testing at the beginning of operations, during foil changes, and every two hours.
The Critical Quality Attributes associated with packing include tablet appearance, correct pack quantity, blister or strip integrity, accurate printed information, proper carton filling, and correct shipper identification. Verification of batch numbers, manufacturing dates, expiry dates, and maximum retail prices helps prevent labeling errors and product mix-ups. Packaging material reconciliation, rejection analysis, yield calculations, and documentation review provide further assurance of batch traceability and accountability. Effective control of CPPs and verification of CQAs help ensure consistent packaging quality, product protection, patient safety, and GMP compliance.
Note: The CPPs and CQAs illustrated are proposed packaging control considerations. Their criticality and acceptance limits should be established through approved specifications, process validation, and documented quality risk assessment.