Friday, November 26, 2010
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.