1. Introduction – Batch Packing Record (BPR) of Mefenamic Acid & Dicyclomine Hydrochloride Tablets IP:
The Batch Packing Record (BPR) of Mefenamic Acid & Dicyclomine Hydrochloride Tablets IP is an essential Good Manufacturing Practice (GMP) document that provides systematic instructions and records for the packaging operations of pharmaceutical tablets. It ensures that every packaging activity is performed under controlled conditions, properly documented, verified, and reviewed to maintain product quality, safety, identity, and traceability. The formulation contains Mefenamic Acid IP 250 mg and Dicyclomine Hydrochloride IP 10 mg per uncoated tablet. The BPR covers the complete packaging process, including the receipt of inspected tablets from manufacturing, packaging material dispensing, equipment verification, line clearance, machine setup, blister packing, overprinting, in-process quality checks, carton packing, shipper packing, and transfer of finished products to the finished goods store. The document specifies essential packaging materials, including printed blister foil, green PVC, cartons, and five-ply corrugated shippers. It also establishes controls for blister sealing temperature, forming temperature, machine speed, leak testing, environmental conditions, packaging accuracy, and verification of batch numbers, manufacturing dates, expiry dates, and pricing information. In-process checks are performed at defined intervals to verify packaging integrity, correct labeling, carton filling, shipper quantities, and compliance with approved packaging requirements. The BPR also includes packaging material reconciliation, rejection analysis, destruction records, yield calculations, and final verification by authorized Production and Quality Assurance personnel. Proper implementation of this BPR helps prevent product mix-ups, incorrect labeling, packaging defects, material discrepancies, and documentation errors. It ensures complete batch traceability, regulatory compliance, accountability, and consistent packaging quality. The completed Batch Packing Record serves as documented evidence that packaging operations have been performed according to approved procedures and provides essential information for batch review, quality assurance, regulatory inspections, and finished product release.
Skip to PDF content2. Flow Diagram – Mefenamic Acid & Dicyclomine Hydrochloride Tablets IP:
The Batch Packing Record (BPR) flow diagram illustrates the systematic packaging process of Mefenamic Acid 250 mg and Dicyclomine Hydrochloride 10 mg Tablets IP. The process begins with receiving inspected tablets from manufacturing, followed by packaging material dispensing, equipment verification, and QA-approved line clearance.
Blister packing is performed under controlled machine settings, including forming temperature, sealing temperature, and machine speed. In-process checks include leak testing, blister integrity, and verification of printed information. Subsequently, blister packs are transferred for carton packing and shipper packing. Packaging materials and finished quantities are reconciled, while rejected materials are documented. Finally, completed batches undergo Production and Quality Assurance review before authorized transfer to the finished goods store, ensuring product quality, traceability, and GMP compliance.
3. Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) of Mefenamic Acid & Dicyclomine Hydrochloride Tablets IP:
The Batch Packing Record (BPR) of Mefenamic Acid 250 mg and Dicyclomine Hydrochloride 10 mg Tablets IP identifies essential Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) associated with pharmaceutical packaging operations.
Critical Process Parameters (CPPs) include blister forming temperature, sealing roller temperature, machine speed, packaging material specifications, machine setup, overprinting accuracy, and in-process inspection frequency. Proper monitoring of these parameters helps prevent packaging defects, tablet damage, leakage, incorrect coding, and product mix-ups.
Critical Quality Attributes (CQAs) include blister integrity, correct tablet count, product identity, tablet appearance, sealing quality, accurate labeling, and packaging protection. These attributes ensure that packaged tablets maintain their required quality, safety, and stability throughout their shelf life.
The BPR establishes documented controls for line clearance, leak testing, carton filling, shipper verification, rejection analysis, and packaging material reconciliation. Regular inspections and Quality Assurance verification help maintain compliance with approved specifications and Good Manufacturing Practice (GMP) requirements. Effective monitoring of CPPs and verification of CQAs ensure consistent packaging quality, batch traceability, product protection, and regulatory compliance.
Note: The specific criticality of each parameter and attribute should be established through approved process knowledge, risk assessment, and validated packaging specifications.