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.

No comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...
Subscribe to Quality Assurance and GMP by Email