1. Introduction:
Beclomethasone Dipropionate, Neomycin Sulphate, Clotrimazole and Chlorocresol Cream is a topical pharmaceutical preparation formulated for external application. According to the Batch Packing Record, each tube contains Beclomethasone Dipropionate IP 0.025% w/w, Neomycin Sulphate IP 0.50% w/w, Clotrimazole IP 1.0% w/w and Chlorocresol IP 0.1% w/w as a preservative, incorporated in a suitable cream base. The product is recommended to be stored at a temperature not exceeding 25°C and should not be frozen. The Batch Packing Record provides documented controls for the complete packing operation, including receipt of bulk cream, dispensing of packing materials, overprinting, line clearance, tube filling and sealing, in-process inspections, carton and shipper packing, rejection recording, sample collection, packing material reconciliation and final batch release. During tube filling, important parameters such as tube cleanliness, empty-tube inspection, filling and sealing, filled-tube inspection, target fill weight and cap sealing are monitored and documented. Proper execution and documentation of these activities help ensure consistent packing quality, correct product identification, traceability, accountability of packaging materials and compliance with established pharmaceutical quality procedures before release of the finished packed batch.
Skip to PDF content2. Flow Diagram Batch Packing Record (BPR):
The Batch Packing Record (BPR) describes the controlled sequence of activities followed during the packing of Beclomethasone Dipropionate, Neomycin Sulphate, Clotrimazole and Chlorocresol Cream. The process begins with receipt of the approved bulk cream and preparation of the packing schedule, including the quantity transferred and approximate number of tubes. Packing materials such as printed laminated tubes, inner cartons, multicartons, shippers and BOPP tape are dispensed and documented. Before packing starts, line clearance is performed to confirm cleanliness, removal of previous product materials, availability of required packing materials and readiness of equipment. QA clearance is required before starting the operation. During tube filling, cleaning, empty-tube inspection, filling, sealing and filled-tube inspection are documented. The BPR specifies a target weight of 10.3 g with a filling range of 10.0–10.9 g and periodic in-process checks.
Filled tubes are subsequently packed into cartons, multicartons and shippers. Coding details, quantities, defects, samples, rejected materials and packing-material accountability are recorded. Finally, Production and Quality Assurance review the completed documentation, reconcile materials and verify the packed batch before final release.
3. CPP and CQA:
Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) are important controls for maintaining consistent quality during the packing of Beclomethasone Dipropionate, Neomycin Sulphate, Clotrimazole and Chlorocresol Cream. The BPR covers critical activities such as line clearance, tube filling and sealing, filled-tube inspection, coding, carton packing and shipper packing. During tube filling, key process controls include tube cleanliness, empty-tube inspection, filling and sealing operations, weighing balance identification and periodic in-process checks. The specified target weight is 10.3 g, with an acceptable filling range of 10.0–10.9 g, while cap sealing is checked for satisfactory condition.
Important quality attributes include correct fill quantity, proper sealing, acceptable tube condition, accurate batch coding and correct packaging configuration. Carton and shipper checks verify batch number, manufacturing date, expiry date, MRP and shipper contents. Proper monitoring and documentation of these parameters support product identification, packaging integrity, traceability and consistent finished-product quality.