Instruction for Calculation

0 Purpose       :      To provide an instruction for calculation in QC department.

2.0 Objective      :    To provide a documented procedure for calculation in QC department.

3.0 Scope     :   This procedure is applicable for calculation in QC department of -----Pharmaceutical Ltd, 

4.0   Responsibility   :

·       Primary   :  QC Chemist / QC Officer

·     Secondary : Overall: QC – Incharge

5.0    Procedure    :

·        Rounding off   figures two (2) digits after the decimal point (esp. in case of Assays /                          potency / sulphated ash).

·       Rounding off figures obtained in sampling plan (for ex. root √n+1= 14.26 then 15 containers shall be sampled).

·       Rounding off assigned qty of R.M. in “ Bill of materials “ having odd quantities. (Reactant / excipient/solvent) in two (2) digits.

·    Molar solutions / strength should be rounded off five (5) digits after decimal point.

·   Working standard potency should be rounded off after two (2) digits of decimal point.

·  Impurity / related substances calculations should be rounded off after three (3) digits of   decimal point.

·  LOD / Water to be rounded off two (2) digits after decimal point.