1. Introduction to Nimesulide & Paracetamol Tablets – Batch Packing Record (BPR):
The Batch Packing Record (BPR) for Nimesulide & Paracetamol Tablets is an essential pharmaceutical document designed to ensure systematic documentation, monitoring, and control of packaging operations in accordance with Good Manufacturing Practices (GMP). Each uncoated tablet contains Nimesulide BP 100 mg and Paracetamol IP 325 mg, formulated as a combination of analgesic and anti-inflammatory agents. The BPR provides comprehensive information regarding batch identification, packaging material dispensing, line clearance, machine setup, overprinting verification, in-process quality checks, and finished product reconciliation. It ensures that packaging activities are performed under controlled conditions to maintain product identity, quality, safety, and traceability. Critical packaging parameters include sealing temperature, forming temperature, machine speed, leak testing, environmental conditions, and verification of printed packaging information. Proper documentation of these parameters helps prevent packaging defects, product mix-ups, incorrect labeling, and contamination. The record also covers packaging material reconciliation, rejection analysis, destruction records, yield calculations, and final verification by Production and Quality Assurance personnel. Nimesulide & Paracetamol Tablets must be stored protected from light and moisture at temperatures not exceeding 30°C. An accurately maintained BPR supports regulatory compliance, batch traceability, quality assurance, and consistent pharmaceutical packaging operations.
Skip to PDF content2. Flow Diagram Description – Batch Packing Process of Nimesulide & Paracetamol Tablets (BPR):
The flow diagram for the Batch Packing Record (BPR) of Nimesulide & Paracetamol Tablets illustrates the systematic sequence of pharmaceutical packaging operations performed in accordance with Good Manufacturing Practices (GMP). Each uncoated tablet contains Nimesulide BP 100 mg and Paracetamol IP 325 mg. The packaging process begins with the receipt of inspected tablets from the manufacturing department, followed by dispensing and verification of packaging materials such as PVC film, aluminium foil, cartons, and shippers. Before initiating packaging, line clearance and machine setup are performed to ensure that the equipment and packaging areas are clean and free from previous product materials. The tablets are subsequently packed using blister packaging equipment under controlled operating conditions. In-process quality checks include verification of sealing temperature, blister integrity, leak testing, packaging appearance, and printed information.
After primary packaging, the blister packs undergo overprinting verification, cartoning, and secondary packaging into corrugated shippers. Finally, packing material reconciliation, rejection analysis, yield calculations, and QA review are performed to confirm packaging accuracy, product traceability, and compliance with approved specifications. The completed Batch Packing Record provides documentary evidence of packaging activities and supports consistent product quality, regulatory compliance, and final batch release.
3. Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) for Nimesulide & Paracetamol Tablets:
The Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) of Nimesulide & Paracetamol Tablets are essential for maintaining pharmaceutical product quality, packaging integrity, and compliance with Good Manufacturing Practices (GMP). Each uncoated tablet contains Nimesulide BP 100 mg and Paracetamol IP 325 mg. Critical Process Parameters during blister packaging include forming temperature, sealing temperature, sealing pressure, machine speed, dwell time, and tablet feeding accuracy. Proper control of these parameters helps prevent defective blisters, improper sealing, and packaging errors.
Critical Quality Attributes include tablet identity, assay, content uniformity, dissolution, disintegration, physical appearance, and impurity limits. Packaging quality attributes include blister integrity, correct labeling, accurate batch coding, and packaging material quality. Effective monitoring, in-process checks, documentation, and quality verification ensure consistent packaging performance and product traceability. The integration of CPP and CQA monitoring supports pharmaceutical quality assurance, minimizes packaging defects, and ensures compliance with approved specifications and regulatory requirements throughout packaging operations.