SOP FOR ANALYST VALIDATION

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  • OBJECTIVE

         To lay down a standard procedure for Analyst Validation.

  • SCOPE

This SOP is applicable for Analyst Validation in Quality Control Laboratory

  • RESPONSIBILITY
    • Officers / Executive – Quality Control.
  • ACCOUNTABILITY
    • Manager-Quality Control and Head QA shall be accountable for compliance of this SOP.
  • ATTACHMENTS

         Format for Acceptance criteria of analyst qualification                           Attachment-I

Format for Qualification of analyst record for Assay                               Attachment-II

Format for test data sheet for analyst validation                                       Attachment-III

  • PROCEDURE

6.1    The analyst shall be validated for analytical techniques, which are coming under his / her responsibility.

6.2    Analyst those approved from FDA does not require qualification, but they can be evaluated for validation if required.

  • Identify approved Raw material and Finished Product.
  • Keep the record of material/Product name, Batch No., AR. No., Code No., and analytical value of sample along with acceptance limit as per Format-
  • Assign appropriate Code No. to each sample identified for qualification as per given below:-

SOP/AV/PC-XXX

Where, SOP= Sano-Cito, AV=Analyst validation, PC=Product Code XXX =Serial No.

  • Give sample for analysis appropriately coded in polybags /glass vial to analyst.
  • Evaluate the Analyst either one or more, in following areas of analysis.
    • Assay (Analysis to be carried out in triplicate).
    • Identification by IR Spectrophotometer/Chemical basis.
    • Loss on drying/ water content (in triplicate).
  • Evaluate the Analyst for one or more of the following analytical method.

HPLC

U.V. Spectrophotometer

Titration

IR Spectrophotometer

  • Evaluate the capability of the Analyst in terms of its precision to perform the tests and GLP followed by the Analyst.
  • The capability to perform tests by Analyst shall be considered satisfactory if the results reported by the Analyst.
    • Are within the acceptable limits as per Format-01.
    • The Analyst complies with GLP.
    • Document the results as per requirement in test data sheet for analyst validation as per Format-03.
  • In case of assay for Raw material and Finished Product, compare all three results and find out RSD of results. The limit for RSD shall not be more than 1% for Raw Material and for Finished Product.
  • Compare the average results with initial results. The difference between two results should not be more than 0.5% for HPLC and UV & ± 1% for titration.
  • In case of IR analysis all three spectra shall match with Reference Spectra.
  • For Qualification of Microbiologist, evaluate the microbiologist with respect to practices followed in the respective area like carrying out Microbiological Limit Test, Preparation of Culture, and Settle Plate etc.
  • Qualify each new Analyst with in three months of the area of work given to them.
  • Keep the details like calculations, chromatograms, and strip chart along with comments of department head in training file to be maintained separately for each Analyst.
  • In case of Analyst found not qualified, re-train the Analyst and do not allot subjected work until he or she is qualified.
  • Maintain records related to Training /Re-training and Re-qualification in training file.
  • Prepare the final report as per Format-
  • REFERENCES

            In-house

  • ABBREVIATIONS

         SOP: Standard Operating Procedure.

QC: Quality Control.

HPLC: High Performance Liquid Chromatography

A.R. No.: Analytical Report Number

RSD: Relative Standard Deviation.

USP: United States Pharmacopoeia

FT: Format.

GLP: Good Laboratory Practices

QA: Quality Control

FDA: Food Drug Administration

  • DISTRIBUTION LIST

Quality Assurance Department

Quality Control Department

  • HISTORY OF REVISION
Version No. Date of Revision Reason for Revision

Attachment-I

Sr.  No. Name of the Material Batch No. AR  No. New code No. Analytical value of the sample along with acceptance limit Remarks

Name of the Analyst: ___________________                                    Date of validation: ___________  

Code No. of sample:   __________________                                      Type of sample: _____________  

 

Test-I

1._________________

2._________________

3._________________

R.S.D.:____________( all 3 values)

 

 Test-II

1._________________

2._________________

3._________________

R.S.D.:____________( all 3 values)

 
Test-III

1._________________

2._________________

3._________________

R.S.D.:____________( all 3 values)
Limit:  R.S.D.: NMT 1.0% for Raw material and Finished product.

Result between initial and observed is ±0.5% for HPLC & UV & 1.0% for titration & for loss on drying results between initial and observed is ±0.2%
Overall Remarks:

 

Verified by name: ____________________                                Approved by:  ___________________

Signature: ________________________                                Signature:   _____________________

Date: _____________________________                                Date:   __________________________

 

 

SOPs