SOP For Tablet Weight Variation

This document outlines the standard operating procedure for tablet weight variation in quality control. It describes taking a sample of 20 tablets to calculate the average weight and check individual weights. The upper and lower percentage deviation is determined by comparing the average to the highest and lowest tablet weights. If the initial parameters are within limits, the compression machine can be started.

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SOP For Tablet Weight Variation

Uploaded by

Mubarak Patel

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as PDF, TXT or read online on Scribd

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7/12/22, 4:37 PM SOP for Tablet Weight Variation

SOP for Tablet Weight Variation

pharmaceuticalsky.com/2022/07/sop-for-tablet-weight-variation.html

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.

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7/12/22, 4:37 PM SOP for Tablet Weight Variation

ABBREVIATIONS

BMR: Batch Manufacturing Record

REVISION HISTORY
Nil

SOP For Tablet Weight Variation

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SOP For Tablet Weight Variation

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7/12/22, 4:37 PM SOP for Tablet Weight Variation

SOP for Tablet Weight Variation

Average Weight of Tablet

Checking Individual Weight Variation

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

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

BMR: Batch Manufacturing Record

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