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Analyst Qualification (Modified)

This document describes procedures for certifying analysts in a quality control laboratory to ensure they can accurately perform analyses. It outlines responsibilities, defines certification, and provides the procedure which involves evaluating an analyst's competency, having them analyze approved samples, comparing results to acceptance criteria, and considering them certified if the results meet limits. Acceptance criteria for different tests are also provided.

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vasant ugale
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2K views

Analyst Qualification (Modified)

This document describes procedures for certifying analysts in a quality control laboratory to ensure they can accurately perform analyses. It outlines responsibilities, defines certification, and provides the procedure which involves evaluating an analyst's competency, having them analyze approved samples, comparing results to acceptance criteria, and considering them certified if the results meet limits. Acceptance criteria for different tests are also provided.

Uploaded by

vasant ugale
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Analyst Validation (Certification) In Quality Control Laboratory

  
This procedure is applicable for the New employee (experienced or fresher), existing analyst
who is changed from one section to another section e.g. Raw material to Finished product or 
enlargement of responsibility, to ensure the capability of the analyst to perform analysis
accurately and to demonstrate the analyst’s ability to perform specific methods as a result of
investigation in QC laboratory.

RESPONSIBILITIES:

Analyst: To perform the analysis for the qualification as per approved procedures and
go through all the necessary trainings.

Quality Control Executive : Responsible for the certification of Analyst and verification of
results and comparison with acceptance criteria.

Quality Control Manager : Responsible for the compliance to this SOP and to ensure the
competence of analyst who operate specific equipment, perform tests and calibrations.

DEFINITION : 

Certification of analyst: This procedure applies to all analyst in Quality control laboratory in


order to ensure that analyst performing the tests are adequately trained to produce reliable and
accurate results within the specified acceptable limits.

PROCEDURE :

Analyst certification shall involve determining the competency on following :

 Understanding of the MOA of the test and analysis performed by the analyst.
 Knowledge about the instruments used by analyst and ability to use them.
 Performing analysis according to approved MOA’s and STP’s.
 Evaluation of the analytical results and reporting.
 Before analyst certification, qc Executive shall ensure that all necessary training has
been imparted to analyst.
 Certification of analyst is not applicable for the operation of physical parameter
measuring devices. Training is essential to operate the below equipment’s and
measuring devices.
 Certification of analyst is mandatory for the operation of instrument like HPLC and
GC.
 Others instrument operation will be dealt according to the below matrix.

Tests on which qualification to be performed


1 Melting Point / Boiling point
2 Refractive Index
3 Optical Rotation / Specific Optical Rotation
4 Residue on Ignition
5 LOD
6 Water Content
7 Assay by Titration
8 FTIR – Identification Test
9 UV – Visible Spectrophotometer - Assay
10 HPLC – Related Substance Test
11 HPLC - Assay
14 MLT Test ( Microbiology)
15 Microbiological Assay

 Recently fresh approved raw material or finished product (previously analysed &
certified in the inhouse Laboratory or by External Approved Laboratory) shall be
given to the analyst to perform testing .The samples are to be coded accordingly.
 Sampling record of the sample drawn for analyst validation to be maintained
 These samples packed in a manner which can prevent exposure to moisture, light and
heat.
 While performing the analysis the analyst must trained to follow the general laboratory
practices and general safety requirements.
 The samples should be suitabley coded (Actual batch no & AR No should not be
disclosed to the Analyst) and allotted.
 The details of the sample allotment should recorded in Analyst Validation Register
 The analysis shall be completed within 10 working days from the receipt date.
 While performing the Analysis/tests & documenting the records , the Analyst should
follow GLP and GDP practices.
 Evaluate the capability of the analyst by comparing the results with the COA of the
Approved sample. and The Quality control Section In charge shall verify the results
and compare with acceptance criteria
 The analyst shall be considered qualified if the results obtained by him / her within the
specification limit and within acceptable limit (as mentioned below) for certification of
analyst.

 ACCEPTANCE CRITERIA:

Tests Permitted variance

Melting Point + 10 from the result of the Approved COA

Refractive Index + 0.05 from the result of the Approved COA

Residue on Ignition + 0.05 from the result of the Approved COA

LOD + 0.2 from the result of the Approved COA

Water Content + 0.2 from the result of the Approved COA

Related substance test for Raw  Any individual impurity:


material by HPLC 1. ±  25 % from the original reported value (if the
value is between 0.1 – 0.2 %).
2. ± 15 %  from the original reported value (if the
value is above  0.2 %).
3. (Values below 0.1 % shall not be considered)
4. Total Impurities; ± 25 % from the original
reported value.

Assay of Raw material by + 0.5% from the result of the Approved COA
Titrimetry

Assay of Raw Material by + 0.5% from the result of the Approved COA
Spectrophotometry

Assay of Raw material by + 1.0% from the result of the Approved COA
HPLC
Assay of Raw Material by + 2.0% from the result of the Approved COA
Microbiology

Microbial Limit Test As per the result of the Approved COA

Assay of Finished Products by + 2.0% from the result of the Approved COA
Titrimetry

Assay of Finished Products by + 2.0% from the result of the Approved COA
Spectrophotometry

Assay of Finished Product by + 2.0% from the result of the Approved COA
HPLC

Assay of Finished Product by + 5.0% from the result of the Approved COA
Microbiology

 If the results found out of acceptance criteria, Q. C. Executive or his nominee shall
conduct investigation through deviation for the cause and if it is due to analytical error,
then the analyst shall be retrained for the respective SOP’s /Procedure and shall be
again qualified.
 The analyst is to be considered as certified, if the analytical results reported by the
analyst during the evaluation study meet the established acceptance criteria.

 
ABBREVIATIONS:
SOP                     :      Standard Operating Procedure
QC                       :       Quality Control
FTIR                     :       Fourier Transform infrared
MOA                     :       Method of analysis
GLP                      :      Good Laboratory Practices
HPLC                    :       High Performance Liquid Chromatograohy
UV                         :       Ultra Voilet Visible
GC                        :       Gas Chromatography
RSD                      :       Relative Standard deviation
STP                       :       Standard testing procedure
 Assay of Finished product and Raw material : Mean difference should not be
more than ± 3 % and RSD of three values should not be more than 1.0 %.
 Dissolution: Mean difference should not differ by 5 % from original value and %
RSD should not be more than 10.0 %.
 Water content by KF apparatus: RSD of three values should not be more than
1.0 %.
 Loss on drying : RSD of three values should not be more than 1.0 %.
 Residual solvents: Mean difference should not be more than 7.5% and RSD of
three values should not be more than 10.0 %.
 Specific optical rotation : Mean difference should not be ± 3 % and RSD of three
values should not be more than 10.0 %.
 FTIR : Results should be comparable with the IR spectrum obtained with reference
Standard.
 Melting point : Results should meet the specification.
 Grammage of aluminium foil : Results should meet the specification.
 Related substances in Finished product and Raw material: Any individual
impurity:

5. ±  25 % from the original reported value (if the value is between 0.1 – 0.2 %).
6. ± 15 %  from the original reported value (if the value is above  0.2 %).
7. (Values below 0.1 % shall not be considered)
8. Total Impurities; ± 25 % from the original reported value.

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