Calculation of Target weight SOPS
1.0 PURPOSE
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Ø
It is established to provide proper procedure for calculation
of target weight.
2.0 SCOPE
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Ø This procedure is applied for calculating the
target weight of new G.R.N. of each powder for
vial.dry powder suspension,
capsules & tablets.
3.0 RESPONSIBILITY
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Ø Production
Manager
Ø Assistant
Manager Production
Ø Production
Pharmacist
Ø
QC Manager
Ø
4.0 PROCEDURE
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4.1). A) Calculation for
Tablet, Capsule, Dry Suspension & Liquid Syrup
Determine the actual assay of active raw material.
Calculate the net base assay. Calculate the factor as
under.
Factor = Mol. Wt of powder salt
Mol. Wt of powder
base
For Example = 367.8 = 1.109
(Ciprofloxacin HCl) 331.4
Weight Adjustment to 100 % to
calculate the Target weight
Target
Weight = Claimed Potency X 100 e.g.:- 500 mg X 100 = 503 mg
(100 %) Actual Assay 99.36
Weight Calculation for Dry Powder
Suspension, Capsules, Tablet & Syrup
Calculate the actual assay of active
ingredients and adjust the quantity to 100 %. Add OVERAGE (if required) then
calculates the target weight including excipients and its min; & max ranges
as per U.S.P. / B.P. limits.
Ø
5.0 QUALITY FORMS AND RECORDS
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Ø
Calculation sheet attached with
BMR.
6.0 DISTRIBUTION
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Ø Head of Operation
Ø Q.A Manager
Ø Production Manager
Ø Q.C Manager
Ø Production Pharmacist