DETERMINATION OF AVERAGE WEIGHT OF TABLETS - SOP

1.0 PURPOSE:
To provide a written procedure for determination of average weight of tablets and checking of individual weight variation.
2.0 SCOPE:
Applicable to determination of average weight of a tablet during in process checking.
3.0 RESPONSIBILITY:
Operator Manufacturing, Executive Manufacturing and Executive QA.
4.0 ACCOUNTABILITY:
Assistant Manager Manufacturing.
5.0 DEFINITIONS:
Nil
6.0 PROCEDURE:
6.1 AVERAGE WEIGHT OF A TABLET:
6.1.1 Check the cleanliness of the balance.
6.1.2 Collect Sample of 20 tablets.
6.1.3 Weigh the tablets, record the weight in BMR.
6.1.4 Calculate the average weight of tablet.
6.1.5 Calculate the mean (average weight of tablets) of average weight of each in Process check.
6.2 CHECKING OF INDIVIDUAL WEIGHT VARIATION:
6.2.1
Collect sample of 20 tablets.
6.2.2 Weigh the tablets, record the weight in BMR.
6.2.3 Calculate the average weight of tablet.
6.2.4 Weigh 20 individual tablets one by one and record the observations in the BMR individually.
6.2.5 Check the lower weight and upper weight for determination of lower and upper percentage deviation.
6.7 Upper % deviation = ( Average weight of 20 tablets – Upper weight)x100/Average weight of 20 tablets
6.8 Lower % deviation = (Average weight of 20 tablets – Lower weight) x 100/Average weight of 20 tablets
6.9 After checking initial parameters, if it is with in the limit, compression machine can be started.
6.10 Fill weight should be checked as per the BMR instructions.
7.0 REFERENCES:
Nil.
8.0 ENCLOSURES:
Nil.
9.0 ABBREVIATIONS:
9.1 BMR : Batch Manufacturing Record.