1. Introduction – Batch Packing Record for Alvida Pile 20 gm:
The Batch Packing Record (BPR) for Alvida Pile 20 gm is a controlled GMP document designed to provide complete and traceable documentation of all filling, sealing, coding, packing, in-process inspection, reconciliation, and release activities performed for each batch. The product contains Beclomethasone Dipropionate IP 0.025% w/w, Phenylephrine HCl IP 0.1% w/w, Lignocaine HCl IP 2.5% w/w, and Chlorocresol IP 0.1% w/w as preservative in a cream base. The BPR ensures that packing operations are carried out according to approved procedures and that critical information such as batch details, packing materials, line clearance, tube filling checks, coding, carton and shipper packing, sampling, rejection, yield, and material accountability is properly recorded. It also provides documented evidence of Production and QA verification throughout the packing process, supporting product identity, traceability, reconciliation, prevention of mix-ups, and GMP compliance. The document includes specific line-clearance requirements before filling and packing and requires QA clearance before the packing operation begins.
Skip to PDF content2. Flow Diagram – Batch Packing Process of Alvida Pile 20 gm:
The Batch Packing Process of Alvida Pile 20 gm is a controlled and documented sequence designed to ensure that the finished product is packed correctly, safely, and in accordance with approved batch packing instructions. The process begins with initiation of the Batch Packing Record and dispensing of approved packing materials such as printed laminated tubes, printed inner cartons, applicators, shrink material, shippers, and BOPP tape. Before packing starts, line clearance is performed to confirm cleanliness of the area and equipment, removal of previous product materials, correct status labeling, and availability of approved packing components. QA clearance is required before starting the operation. The cream is then filled into laminated tubes, followed by cap closing, sealing, and periodic in-process checks of fill weight and sealing condition.
The filled tubes are coded with batch number, manufacturing date, expiry date, and MRP, packed into printed cartons, shrink-packed, and finally placed into shippers. In-process checks verify coding, packing integrity, shipper contents, and associated details. After packing, samples are collected, packing materials are reconciled, yield is recorded, and the completed BPR is reviewed by Production and QA. The packed batch is then verified and released after satisfactory documentation review.
3. Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) for Alvida Pile 20 gm:
The Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) for Alvida Pile 20 gm are essential controls used to ensure consistent packing performance and acceptable finished-product quality. During tube filling, important CPPs include fill weight, filling machine speed, tube positioning, and other operating conditions that can directly influence the quantity and uniformity of product filled into each tube. The BPR specifies a target weight of 20.3 g with an acceptable filling range of 20.0–21.8 g, together with cap-sealing verification during in-process checks. Other critical packing parameters include correct overprinting, tube and carton coding, proper packing into cartons and shippers, and verification of packing operations. The BPR requires checks for batch number, manufacturing date, expiry date, MRP, shipper contents, and production/QA verification during packing.
The corresponding CQAs include correct product identity, acceptable fill weight, secure tube sealing, legible coding, correct packing configuration, freedom from mix-up or damage, and accurate quantity reconciliation. Packing-material accountability, wastage, returns, sampling, actual yield, and final QA review further confirm that the packed batch meets established quality and documentation requirements before release.