1. INTRODUCTION – PARACETAMOL & DICYCLOMINE HYDROCHLORIDE:
The Batch Packing Record (BPR) for Paracetamol & Dicyclomine Hydrochloride Tablets is a comprehensive Good Manufacturing Practice (GMP) documentation system designed to ensure the controlled, consistent, and traceable packaging of pharmaceutical tablets. It provides detailed instructions and recording formats for packaging operations, in-process quality checks, material reconciliation, and final batch verification. Each uncoated tablet contains Paracetamol IP 325 mg and Dicyclomine Hydrochloride IP 20 mg, with a specified packaging configuration of 20 × 10 tablets (Green). The product is required to be stored in a cool, dark, and dry place. The BPR begins with essential batch information, including product name, batch number, manufacturing date, expiry date, batch size, and packaging schedule. It includes documentation for packaging material dispensing, verification, overprinting, and line clearance to prevent product mix-ups, labeling errors, and cross-contamination. The record also covers packaging line setup, sealing and forming roller temperatures, machine operating conditions, leak testing, and periodic in-process inspections. These controls help maintain packaging integrity, product identification, and compliance with approved specifications. Additional sections address carton and shipper verification, packaging material reconciliation, rejection analysis, destruction records, finished product transfer, and yield calculations. Each critical activity requires appropriate documentation and verification by authorized Production and Quality Assurance personnel. The primary objective of this BPR is to establish complete batch traceability, maintain packaging quality, minimize errors, and provide documented evidence that packaging operations have been performed according to approved procedures. The BPR serves as an essential quality assurance document supporting batch review, regulatory inspections, deviation investigations, and final product release in accordance with applicable GMP requirements.
Skip to PDF content2. PARACETAMOL & DICYCLOMINE HYDROCHLORIDE TABLETS – FLOW DIAGRAM:
The flow diagram illustrates the systematic packaging process for Paracetamol IP 325 mg and Dicyclomine Hydrochloride IP 20 mg Tablets, ensuring compliance with Good Manufacturing Practices (GMP) and approved Batch Packing Record (BPR) procedures. The process begins with receiving inspected tablets from the manufacturing department, followed by packaging material dispensing, verification, and documented line clearance. Packaging machinery is then configured for blister or strip packing, with appropriate sealing temperatures, machine settings, and operating conditions.
During packaging, critical in-process checks include blister integrity, leak testing, overprinting accuracy, tablet count, and verification of manufacturing and expiry dates. Subsequently, blister strips are packed into cartons according to the specified 20 × 10 tablets (Green) configuration. The process continues with packaging material reconciliation, rejection analysis, yield calculation, and Quality Assurance review. Any identified discrepancies must be investigated and appropriately resolved before batch acceptance. Following satisfactory verification, finished packed goods are transferred to the designated finished goods store, with complete documentation and authorized approvals. The BPR flow diagram emphasizes product traceability, packaging integrity, accurate labeling, prevention of mix-ups, and comprehensive GMP documentation throughout the packaging process.
3. BATCH PACKING RECORD PARACETAMOL & DICYCLOMINE HYDROCHLORIDE TABLETS – CPP AND CQA DESCRIPTION:
The Batch Packing Record (BPR) for Paracetamol & Dicyclomine Hydrochloride Tablets establishes essential controls for Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) to ensure consistent packaging quality, product identification, and compliance with Good Manufacturing Practices (GMP). Each uncoated tablet contains Paracetamol IP 325 mg and Dicyclomine Hydrochloride IP 20 mg, with a specified pack configuration of 20 × 10 tablets (Green).
The key packaging process parameters include sealing roller temperature (170–210°C), forming roller temperature (140–170°C), machine speed, packaging line clearance, environmental temperature and relative humidity, overprinting verification, and periodic in-process inspections. These parameters are monitored to maintain packaging integrity and prevent defects. Important quality attributes include tablet appearance, accurate tablet count, blister or strip seal integrity, correct batch coding, legible manufacturing and expiry dates, packaging material quality, and carton and shipper integrity. The BPR also incorporates leak testing, rejection analysis, material reconciliation, yield verification, and Quality Assurance review. Effective monitoring of CPPs and verification of CQAs help minimize packaging defects, prevent product mix-ups, maintain traceability, and ensure that finished packed tablets meet approved quality requirements.
Note: The BPR specifies packaging controls and checks; formal CPP and CQA classifications should be confirmed through an approved quality risk assessment.