1. Introduction – Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate and Menthol Gel (BPR):
The Batch Packing Record (BPR) for Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate and Menthol Gel is a controlled pharmaceutical document designed to provide complete and traceable documentation of all activities performed during the filling, sealing, coding, packing, inspection, reconciliation, sampling, and final release of the finished product. The product covered in the record is IGMADINE 20 GM, containing Diclofenac Diethylamine equivalent to Diclofenac Sodium BP 1% w/w, Linseed Oil BP 3.00% w/w, Methyl Salicylate IP 10.00% w/w, Menthol IP 5.00% w/w, and Benzyl Alcohol IP 1.00% w/w. The specified storage condition is a temperature not exceeding 25°C with protection from freezing.The BPR establishes documented controls for the receipt and dispensing of packaging materials, line clearance of overprinting and filling areas, verification of coding details, and execution of tube filling and sealing activities. It also provides structured in-process monitoring of tube filling, including a target weight of 30.9 g, an acceptable filling range of 30.0–32.7 g, cap-sealing verification, and checks at a frequency of 60 minutes. In addition, the document controls carton and shipper packing, records recoverable and non-recoverable rejections, documents defects or deviations, provides sample collection details, and supports final verification and release by Production and Quality Assurance. This systematic documentation helps maintain product identity, packing accuracy, traceability, accountability, and compliance throughout the complete packaging operation.
Skip to PDF content2. Flow Diagram – Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate and Menthol Gel:
The packing process flow diagram for Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate and Menthol Gel illustrates the controlled sequence of activities followed during filling, sealing, coding, packing, inspection, reconciliation, and transfer of the finished product. The process begins with the dispensing and verification of required packaging materials, including laminated tubes, inner cartons, multicartons, shippers, and BOPP tape, as specified in the Batch Packing Record.
Before starting operations, line clearance is performed to ensure that the area, equipment, previous product remnants, labels, and packing materials have been removed and the required machine setup is verified. Approved batch details such as batch number, manufacturing date, expiry date, and MRP are then overprinted and checked.The product is subsequently filled into tubes and sealed, with in-process checks performed at defined intervals. The BPR specifies a target weight of 30.9 g, an acceptable filling range of 30.0–32.7 g, cap-sealing verification, and a checking frequency of 60 minutes. After inspection, filled tubes are packed into cartons, multicartons, and shippers. Final activities include shipper checking, material reconciliation, sample collection, documentation review, and release of the packed batch by authorized Production and Quality Assurance personnel.
3. CPP and CQA – Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate and Menthol Gel Packing Process:
The Critical Process Parameters (CPPs) for packing Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate and Menthol Gel include control of fill weight, tube sealing, coding/overprinting, packing operations, line clearance, and environmental conditions. The BPR specifies a target tube weight of 30.9 g with an acceptable range of 30.0–32.7 g, with in-process verification at defined intervals.
The associated Critical Quality Attributes (CQAs) include correct fill quantity, proper seal integrity, accurate and legible coding, correct pack configuration, acceptable appearance, and complete labeling traceability. Effective control of CPPs ensures the packed product remains consistent, correctly identified, properly sealed, and suitable for QA verification and final release.