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.
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
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