1. Introduction – Aceclofenac, Serratiopeptidase & Paracetamol Tablets:
Aceclofenac, Serratiopeptidase & Paracetamol Tablets are a combination pharmaceutical dosage form intended to provide analgesic, anti-inflammatory, antipyretic, and supportive anti-inflammatory action. According to the Batch Packing Record, each film-coated tablet contains Aceclofenac IP 100 mg, Serratiopeptidase IP 10 mg (equivalent to 20,000 units as enteric-coated granules), and Paracetamol IP 325 mg, along with suitable excipients. The product is coloured with Sunset Yellow FCF and is required to be stored below 30°C, protected from light and moisture. ACECLOFENAC, SERRATIOPEPTID… The Batch Packing Record is designed to document and control all important activities performed during pharmaceutical packaging. It covers the transfer of inspected tablets to the packing section, dispensing of packaging materials, overprinting verification, line clearance, machine setup, leak testing, and in-process packing checks. It also provides records for blister or strip inspection, carton and shipper verification, packing material reconciliation, rejection analysis, destruction of rejected materials, and final yield calculation.Proper completion of this BPR ensures batch traceability, reconciliation of packaging materials, prevention of product or printed-material mix-ups, and documented verification by Production and Quality Assurance personnel. The record therefore provides essential evidence that the finished product has been packed under controlled and documented conditions before final release.
Skip to PDF content2. Flow Diagram:
The flow diagram illustrates the systematic batch packing process for Aceclofenac, Serratiopeptidase & Paracetamol Tablets. The process begins with the transfer of inspected tablets from the manufacturing section to the packing section, where the quantity and batch details are verified. Packaging materials such as printed aluminium foil, base foil, cartons, and shippers are then dispensed and checked against approved requirements. Before packing starts, line clearance and machine setup are performed to ensure that the area and equipment are clean, free from materials of the previous batch, and properly prepared. The tablets are subsequently packed using the specified blister or strip packing system. Critical in-process checks, including sealing parameters, leak testing, environmental conditions, pack integrity, and printing details, are monitored during operation.
Online inspection is performed to identify defective packs, missing tablets, improper sealing, or printing errors. Acceptable blister or strip packs are then packed into cartons and subsequently into shippers. After completion, all issued, used, rejected, returned, and destroyed packaging materials are reconciled. Final packed quantity and yield are calculated, and the completed Batch Packing Record is reviewed and verified by Production and Quality Assurance before final product release.
3. Critical Process Parameters (CPP) and Critical Quality Attributes (CQA):
The CPP and CQA diagram illustrates the key process controls and quality requirements involved in the batch packing of Aceclofenac, Serratiopeptidase & Paracetamol Tablets. The packing process begins with the transfer of inspected tablets, followed by dispensing of packaging materials, line clearance, machine setup, primary packing, online inspection, secondary packing, reconciliation, and final Quality Assurance review.
Critical Process Parameters (CPPs) include proper quantity transfer, segregation control, verification of packaging materials, line clearance, sealing temperature, pressure, dwell time, machine speed, forming conditions, inspection frequency, coding details, carton loading, and reconciliation of issued and returned materials. These parameters must be controlled within approved limits to ensure consistent packing performance.
Critical Quality Attributes (CQAs) include correct product identity, absence of mix-up or contamination, intact tablets, correct printed artwork, proper seal integrity, accurate batch and expiry details, correct tablet count, acceptable blister or strip appearance, intact cartons and shippers, and accurate reconciliation records.
Effective control of CPPs helps ensure that the final packed product consistently meets its predefined CQAs and remains suitable for final QA approval and market release.