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Annexure I

Cleaning Validation Protocol & Report for Mefenamic Acid IP

The Cleaning Validation Protocol & Report for Mefenamic Acid IP provides a structured format for evaluating residue removal from manufacturing equipment after successive batches. It identifies critical sampling locations on equipment such as the stirrer tank, sugar tank, manufacturing tank, transfer pump, storage tank, filter press, basket filter, homogeniser, and filling machine. Samples are collected from difficult-to-clean and product-contact areas including valves, lids, stirrers, inner surfaces, inlets, outlets, filter plates, screens, filling nozzles, hoses, and silicone tubes. The recorded residue detection results help demonstrate cleaning consistency and support documented verification of equipment cleanliness.

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