Format of Testing Specifications of Tablet

Testing Specification

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 621, USP	Must be positive.
	Assay	Chromatography 621, USP	90.0 to 115% of the labeled amount
Compression	Average weight	Uniformity of dosage units 905— 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±2○C	Not more than 15 minutes
	Identification	Chromatography 621, USP	Must be positive.
	Assay	Chromatography 621, 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.