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Various process parameters which shall be recorded for establishing the trend and / or verification of designed parameters are as under.
Tablets: Assay values for finished products, DT, Dissolution, Average weight and Yield.
Capsules: Assay values for finished products, DT, Dissolution, Average weight, Uniformity of content and Yield.
Metered Dose Inhalers: Product concentrate, number of deliveries per inhaler, Leakage rate, Water content, Deposition of emitted dose, Weight average by container/ weight of content per container, Weight average by dose/ mean weight per metered dose, Total content of active material/ container, Assay of active per actuation and Yield.
Raw Material: Assay, LOD, pH, Loss on ignition, Absorption test, Bulk Density, Water content, Optical rotation, Color of Solution.
Primary Packaging Material: Grammage, Thickness, Width, Canister Body diameter, Brimful volume, Canister depth, Canister inside diameter, Canister minimum parallel, Canister neck depth, Neck diameter, Neck thickness, Overall length, Rim diameter, Rim thickness, Wall thickness, Canister weight, Ferrule long skirt length of valve, Main valve outside diameter, Ferrule top to step height, Length of core extension, Core extension diameter, Total height, Nominal stroke.
Water System: pH value of Potable and Purified water, Online conductivity value of purified water, Online TOC value of purified water.
Minimum 3 batches in a year or all the batches, less then 3 batches/lots in a year shall not be considered for trend analysis.
Any physical parameter which appears to be deviating more, frequency for IPQA check for such parameter can be increased.
Based on the observed trend analysis, if any change is to be incorporated, it shall be executed as per Change Control procedure
