1. Introduction – Batch Packing Record for Hydroquinone, Tretinoin & Mometasone Furoate Cream:
The Standard Operating Procedure for Batch Packing Record of Hydroquinone, Tretinoin & Mometasone Furoate Cream is established to provide a controlled, systematic, and documented approach for carrying out and recording all activities associated with the filling, sealing, coding, packing, in-process checking, reconciliation, and final verification of the product. The referenced Batch Packing Record is for IGMADINE 20 GM, containing Hydroquinone USP 2.00% w/w, Tretinoin USP 0.025% w/w, and Mometasone Furoate IP 0.10% w/w in a cream base, with a pack size of 20 g. This SOP ensures that packing activities are performed consistently according to approved instructions and Good Manufacturing Practices. It covers receipt and dispensing of packing materials, line clearance of overprinting and filling/packing areas, verification of coding details, inspection of empty and filled tubes, filling and sealing operations, carton and shipper packing, and documentation of recoverable and non-recoverable rejections. The BPR also requires periodic in-process monitoring of tube fill weight and cap sealing, with a specified filling range and checks at defined intervals. The procedure further ensures traceability through recording of batch number, manufacturing and expiry dates, packing material quantities, sample collection, defects or deviations, shipper checking, and material reconciliation. Any additional material request, material return, brought-forward or carry-forward material is appropriately documented. Final verification and release are performed by authorized Production and Quality Assurance personnel. Overall, this SOP provides documented assurance that the finished cream is packed correctly, securely, accurately identified, and maintained in compliance with established quality requirements before release.
Skip to PDF content2. Flow Diagram – Batch Packing Record for Hydroquinone, Tretinoin & Mometasone Furoate Cream:
The Batch Packing Record for Hydroquinone, Tretinoin & Mometasone Furoate Cream describes the controlled sequence of activities required for filling, sealing, packing, checking, reconciliation, documentation, and final release of the finished product. The record applies to IGMADINE 20 GM, packed in 20 g tubes and containing Hydroquinone USP 2.00% w/w, Tretinoin USP 0.025% w/w, and Mometasone Furoate IP 0.10% w/w. The process starts with dispensing and verification of approved packing materials, followed by line clearance of the overprinting and filling/packing areas. Correct batch details such as batch number, manufacturing date, expiry date, MRP, and printed components are verified before use.
During tube filling, the record requires checks for tube cleaning, empty-tube inspection, filling and sealing, filled-tube inspection, weighing balance identification, target weight, filling range, and cap sealing status. In-process checks are performed at a defined frequency of 60 minutes. After filling, tubes are packed into inner cartons, multi-cartons, and shippers with coding and pack details verified by Production and QA. The BPR also documents recoverable and non-recoverable rejections, deviations, sample collection, material reconciliation, shipper verification, and final release by authorized Production and Quality Assurance personnel, ensuring complete batch traceability and GMP compliance.
3. CPP and CQA – Batch Packing Record for Hydroquinone, Tretinoin & Mometasone Furoate Cream:
The Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) for Batch Packing of Hydroquinone, Tretinoin & Mometasone Furoate Cream are essential for ensuring that each packed unit is consistently filled, sealed, coded, inspected, and presented according to approved requirements. The product is packed as IGMADINE 20 GM, containing Hydroquinone USP 2.00% w/w, Tretinoin USP 0.025% w/w, and Mometasone Furoate IP 0.10% w/w in a cream base.
The important CPPs during packing include correct line clearance, proper tube filling, control of fill weight, effective sealing, accurate overprinting, correct coding, and defined in-process inspection frequency. The BPR specifies a target filled weight of 20.3 g, an acceptable filling range of 20.0–21.1 g, cap-sealing verification, and in-process checks at 60-minute intervals. The associated CQAs include correct fill quantity, intact tube condition, satisfactory sealing, legible batch coding, correct manufacturing and expiry details, accurate carton and shipper packing, and absence of visible defects. Carton and shipper checks also verify batch number, manufacturing date, expiry date, MRP, outer pack, and shipper contents. Effective control of CPPs and verification of CQAs help ensure packaging integrity, traceability, correct identification, product protection, and overall GMP compliance before final QA release.