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Tuesday, October 22, 2019

Format for In process Control of Tablet

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IN PROCESS CONTROLS

Manufacturing Stage

Test Parameters

Test method

Specifications
Dispensing
Temperature & Humidity
Hygrometer: note the displayed temperature and humidity before, during and after dispensing 
37˚C±2  and 40%±5%
Cleanliness
Visual Inspection
Free of particulates and other raw materials that are not of the batch being dispensed
Material Identification
Visual Inspection
Ensure the labelling like expiry date, material name, quantity etc, are in accordance to the materials being dispensed 
Material Quantity
Visual Inspection using Weighing Balance
Ensure the dispensed quantities are in accordance to that mentioned on the BMR
Lubrication  (Mixing)
Temperature & Humidity
Hygrometer: note the displayed temperature and humidity before, during and after process 
37˚C±2  and 40%±5%
Cleanliness
Visual Inspection
Free of particulates and other raw materials that are not of the batch being produced
Time of Mixing
Visual Inspection using Stop watch 
1.0hours  
Appearance 
Visual Inspection   
Almost pale white colored powder 
Identification
Chromatography  , USP / BP
Must be positive.
Assay
Chromatography , USP /BP
90.0 to 115% of the labeled amount
Compression
Average weight 
for Tablets; meets the requirements. Performed at different intervals during compression on a average of 10 tablets
75 to 125% of the average content
Disintegration
Performed at different intervals during compression on 6 tablets using DT apparatus containing water at 37±2C
Not more than 15 minutes
Identification
Chromatography , USP
Must be positive.
Assay
Chromatography , USP
90.0 to 115% of the labeled amount
Blistering
Appearance
Visual determination as per the specified batch
Batch number and expiry date embossing be correct
Leakage test
Performed at intervals on an average of 3 blisters
Vacuum seal tester using dyed water
Labeling & Packing
Appearance of unit carton
Visual Inspection
Unit carton must be neat and tidy and the manufacturing batch number, manufacturing and expiry date ant other particulars should be as per specified BMR details. 
Appearance of Finished Pack
Visual Inspection
Must contain the number of proper blisters as specified in the particular product BMR accompanied with a patient information leaflet.



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