ANALYST QUALIFICATION

• OBJECTIVE 

To lay down a procedure for Qualifying the Analyst before assigning them the analytical work.        

1. SCOPE

This SOP shall be applicable for Qualification of Analyst in Quality Control Department of  XYZ LTD.

1. RESPONSIBILITY
   1. Execution – Tr. Executive and above -QC Department  
   2. Checking – Asst. Manager and above -QC Department  
2. ACCOUNTABILITY

Head of the QC Department  

• PROCEDURE

1. 1. Identify approved Raw Material and Finish Product and prepare a list. 
   2. Keep the record i.e Name of analyst, Datasheet issuance number, material /product Name, Batch No./ A.R. No, Code No., test to be performed and instrument used, analytical value of sample with initial and present value etc.
   3. Assign appropriate code No. to each sample identified for qualification.
   4. Give sample for analysis appropriately coded in polybags/glass vials to Analyst.
   5. Provide detail Standard Test Procedure to Analyst.
   6. Evaluate the Analyst either two or more, in following areas of analysis.

1. Assay (Analysis to be carried out in triplicate)      
2. Dissolution
3. Identification by IR Spectrophotometer (Analysis to be carried out in triplicate)
4. Related Substances/ Residual Solvents 

1. Evaluate the Analyst for one or more of the following analytical method

1. HPLC
2. U.V. Spectrophotometer
3. Titration (By Autotitrator)
4. IR Spectrophotometer
5. GC
6. AAS

1. Issuance number  shall be as follows:

E. code/XX/YY

Where:-

XX    – Version (Start from 00)

  YY – Year.

1. The capability to perform tests by Analyst shall be considered satisfactory if the results reported by the Analyst.

1. Are within the acceptable limits .         
2. The Analyst complies with GLP.
3. Documents the results as per requirement.

1. Acceptance Limit for Qualification
   1. In case of assay for Raw material and Finished Product, compare all three results with previous Results and find out RSD of all four results. The limit for RSD shall not be more than 1% for Raw Material and not more than 2% for Finished Product.
   2. In case of Dissolution, compare the results with the previous result and deviation between  

             the two results (mean) should be in the range of ±5% for that approved batch.

1.  In case of IR analysis all three spectra shall match with Reference Spectra or with the IR spectra obtained from reference / working standard.
2.   In case of Related substance/ residual solvents (OVI) compare the results with previous result and deviation should be in the range of ± 10% for that approved batch.   

1. Qualify each new Analyst before assigning the job of analysis in the area of work given to them.
2. After analysis collect all data for analysis and enter Batch no. / ARD No. of the given sample.
3. 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.  
4. Requalify the analyst if the results reported by the analyst do not pass the Acceptance Limit for Qualification . 
5. New sample is again given to the analyst with proper coding and repeat the steps.
6. Do not allot subjected work until he or she is qualified.
7. Maintain records related to Training /Re-training and Re-qualification in training file.

Analyst qualification format:

FOR ASSAY

Verified  by: ____________________                        Approved by :         _______________________

                          (QC Section Incharge)                                                                           (QC Head)                                            

                                 Sign & Date                                                                                     Sign & Date

 
FOR DISSOLUTION 

Verified  by: ____________________                        Approved by :         _______________________

                          (QC Section Incharge)                                                                           (QC Head)                                            

                                 Sign & Date                                                                                     Sign & Date

 FOR IDENTIFICATION 

(By IR Spectrophotometer) 

 Verified  by: ____________________                        Approved by :         _______________________

                          (QC Section Incharge)                                                                           (QC Head)                                            

                                 Sign & Date                                                                                     Sign & Date

  FOR RELATED SUBSTANCES / RESIDUAL SOLVENTS (OVI)

Verified  by: ____________________                        Approved by :         _______________________

                          (QC Section Incharge)                                                                           (QC Head)                                            

                                 Sign & Date                                                                                     Sign & Date

About the Author

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Administrator

"A seasoned professional with a Master's in Chemistry, the author brings more than two decades of expertise in Quality Control, Analytical Method Validation, and advanced QMS investigation. Their experience is globally validated by successful management of major regulatory audits, including those conducted by the US, EU, Brazil, and Russian authorities."

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