Monday, November 29, 2010

Validation of QC Chemist

1.0      Purpose      :     To provide an instruction for the validation of QC Chemist.

2.0      Objective     :   To provide a documented procedure for the validation of QC Chemist.

3.0        Scope     :  This procedure is applicable for QC Chemist of ----Pharmaceuticals Ltd,.

4.0      Responsibility  :
·       Primary      :  QC Chemist / QC-Officer
·       Secondary :  Overall: QC – In charge

5.0      Procedure    :
·       Following method used for the validation of QC Chemist to confirmed his / her analytical skills.
Ø         QC In-charge identifies a previously analyzed and approved batch sample.
Ø         Identified batch sample shall be coded and hand over to QC Chemist with all the
                 details of test procedure.
·       QC Chemist qualified on the criterion as follows:
Ø            QC Chemist performs the analysis and documents the result as per Good             Laboratory  Practices.
Ø            QC Chemist performs the analysis and meets the acceptance criteria as per below
                        mentioned table.
Ø            The QC Chemist working in laboratory shall be qualified on one or more tests as
                          required by the QC In-charge.
Ø            The QC Chemist shall be qualified once a year.
Ø            A record shall be maintained.
Ø            Incase of QC Chemist fails to meet the criteria, the QC Chemist shall be trained and  re-qualified. The training record shall be recorded

                Acceptance Criteria for Chemist Validation
Sr. No.
Test
Acceptance Criteria
01
Assay test by HPLC
% RSD of Retention Time and Area of six replicate injection should not more than 2 %
02
Impurity test by HPLC
% RSD of two replicate injection for highest impurity should not more than 10 %
03
IR test
Three separate analysis, which shall be concordant with each other.
04
Water / LOD test
% RSD of triplicate analysis should not more than 2 %
10 % moisture / LOD range 0 to 0.5 % 
5 % moisture / LOD range 0.5 to 2.0 % 
2 % moisture / LOD range 2 % above
05
UV test
% RSD of three replicated absorption of solution of particular concentration at specified wavelength should not be more than 2 %
06
GC test
% RSD of Retention Time and Area of six replicate injection should not more than 2 %
07
Sp. Gravity test
% RSD of six replicates reading should not more than 2 %
08
Specific Optical Rotation test
% RSD of six replicates reading should not more than 2 %
09
Assay by chemically test
% RSD of six replicate analysis should not be more than   2 %

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