1. Introduction:
The Batch Packing Record (BPR) for Mefenamic Acid & Dicyclomine Hydrochloride Tablets is a comprehensive Good Manufacturing Practices (GMP) documentation system designed to ensure controlled, consistent, and traceable pharmaceutical packaging operations. It provides documented evidence of packaging activities, material utilization, in-process quality checks, reconciliation, rejection analysis, and final batch verification.The product, MEFRON SPAS Tablets, contains Mefenamic Acid IP 250 mg and Dicyclomine Hydrochloride IP 10 mg per uncoated tablet. The specified pack configuration is 5 × 5 × 10 tablets, with storage instructions to maintain the product in a cool, dry, and dark place, protected from light.The BPR establishes a systematic approach to the receipt of inspected tablets, issuance and dispensing of packaging materials, verification of overprinting details, and line clearance before commencing packaging operations. It includes machine setup verification, sealing and forming roller temperature monitoring, machine speed checks, environmental monitoring, leak testing, and verification of carton and shipper filling quantities.During packaging, in-process quality controls are performed at defined intervals to verify packaging integrity, printed information, product identification, and quantity accuracy. Leak testing is documented initially, during foil changes, and every two hours, while carton and shipper filling quantities are checked periodically.The record also incorporates packaging material reconciliation, rejection analysis, destruction records, yield calculations, and finished product transfer documentation. These activities help identify packaging discrepancies, minimize material losses, prevent product mix-ups, and maintain complete batch traceability.All relevant activities are documented and verified by authorized Production and Quality Assurance personnel. Final review and approval provide assurance that packaging operations have been appropriately recorded and evaluated before batch release.The primary objective of this BPR is to maintain product identity, packaging integrity, documentation accuracy, material accountability, and regulatory compliance throughout the pharmaceutical packaging process.
Skip to PDF content2. FLOW DIAGRAM – BATCH PACKING RECORD (BPR) FOR MEFENAMIC ACID & DICYCLOMINE HYDROCHLORIDE TABLETS:
The flow diagram illustrates the systematic sequence of packaging operations for Mefenamic Acid IP 250 mg and Dicyclomine Hydrochloride IP 10 mg Tablets (MEFRON SPAS) in accordance with the Batch Packing Record (BPR).The process begins with BPR initiation, including verification of product name, batch number, manufacturing date, expiry date, and batch size. Inspected tablets are received from the manufacturing department, followed by dispensing and verification of approved packaging materials.Overprinting details on foils, cartons, and shippers are checked to ensure correct product identification and labeling.
Line clearance is performed by authorized personnel before machine setup and commencement of blister or strip packing operations. During packaging, critical parameters such as sealing temperature, forming temperature, machine speed, and packaging integrity are monitored. In-process quality checks include leak testing, carton filling verification, shipper quantity checks, and examination of printed information. After completing packaging, materials are reconciled, rejected quantities are documented, and applicable destruction records are maintained. Finished products are transferred to the finished goods store with appropriate documentation. Finally, the completed BPR undergoes review and approval by Production and Quality Assurance personnel to ensure GMP compliance, packaging integrity, material accountability, batch traceability, and documentation accuracy throughout the packaging process.
3. BENEFITS OF FOLLOWING SOP -BATCH PACKING RECORD (BPR) FOR MEFENAMIC ACID & DICYCLOMINE HYDROCHLORIDE TABLETS:
Following the Standard Operating Procedure (SOP) for the Batch Packing Record (BPR) of Mefenamic Acid & Dicyclomine Hydrochloride Tablets ensures systematic, controlled, and GMP-compliant pharmaceutical packaging operations.The SOP maintains product identity and packaging integrity by ensuring accurate verification of product details, batch numbers, manufacturing dates, expiry dates, and labeling information. Proper line clearance and overprinting verification minimize the risks of product mix-ups, incorrect labeling, and cross-contamination.It strengthens material accountability through controlled issuance, utilization, reconciliation, and return of packaging materials. Routine in-process quality checks, including sealing temperature monitoring, leak testing, and verification of carton and shipper quantities, help maintain consistent packaging quality.
Accurate documentation provides complete traceability of packaging operations and supports regulatory inspections, internal audits, and batch investigations. Recording rejected materials, packaging defects, and destruction activities facilitates effective rejection analysis and reduction of avoidable material losses.The SOP also defines responsibilities for Production and Quality Assurance personnel, ensuring appropriate verification, review, and approval of completed packaging records.Overall, implementing this SOP enhances operational efficiency, documentation accuracy, regulatory compliance, and product quality assurance. It supports effective batch reconciliation, facilitates deviation investigations, and helps ensure that only appropriately reviewed and approved pharmaceutical products proceed for distribution.s