SOP for Tablet Weight Variation

OBJECTIVE

This SOP describes the procedure for the operation of the Tablet Weight Variation.

SCOPE

This SOP applies to the Operation of the Tablet Weight Variation.

RESPONSIBILITY:

It is the responsibility of QC Executives to follow the procedure without deviation. 

ACCOUNTABILITY:

Assistant Manager – Quality Control 

Manager – Quality Assurance 

PROCEDURE

Average Weight of Tablet

• Check the cleanliness of the balance.
• Collect Sample of 20 tablets.
• Weigh the tablets, and record the weight in BMR.
• Calculate the average weight of the tablet.
• Calculate the mean (average weight of tablets) of an average weight of each in the Process check.

Checking Individual Weight Variation

• Collect a sample of 20 tablets.
• Weigh the tablets, and record the weight in BMR.
• Calculate the average weight of the tablet.
• Weigh 20 individual tablets one by one and record the observations in the BMR individually.
• Check the lower weight and upper weight for determination of lower and upper percentage deviation.

Upper % deviation = (Average weight of 20 tablets – Upper weight) x 100/Average weight of 20 tablets
Lower % deviation = (Average weight of 20 tablets – Lower weight) x 100/Average weight of 20 tablets

• After checking the initial parameters, if it is within the limit, the compression machine can be started.

ABBREVIATIONS
BMR: Batch Manufacturing Record

REVISION HISTORY

Nil

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