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Tuesday, August 26, 2008

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.

3 comments:

nilesh said...

dear sir,
we have 45 stn compression m/c now whave check 50 tabs on each side at start and 20 tabs after every 2 hrs but now our QA forcess us do 50 tabs every time on each side
pls reply on
nileshnvm123@yahoo.com
NILESH MULE-+919423282763
WAITING YOUR REPLY

Rastogi K N said...

Dear Mr. Nilesh Mule,

If initially you have checked for 50 tablets on each side, then it is OK to check 20 tabs from either side after every 2hours. As no of punches is not the criteria for testing 20 tablets. This is irrespective of no of punches.

K N Rastogi
Email: rastogikn@gmail.com
Mobile: 9756987850

Sushil Lathwal said...

dear sir
plz tell me why we take 20 tablets for average wt. determination
and in content uniformity test we take 10 tablets only
plz reply on
sushil.lathwal8@gmail.com
09998572491
waiting for ur reply