CALCULATION OF TARGET WEIGHT SOP


Calculation of Target weight SOPS 


1.0   PURPOSE

Ø  It is established to provide proper procedure for calculation of target weight.


2.0  SCOPE
           
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

Ø  Production Manager
Ø  Assistant Manager Production
Ø  Production Pharmacist
Ø  QC Manager
Ø   
4.0   PROCEDURE

   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

Ø  Calculation sheet attached with BMR.

6.0   DISTRIBUTION

Ø  Head of Operation
Ø  Q.A Manager
Ø  Production Manager
Ø  Q.C Manager
Ø  Production Pharmacist


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