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 %