SOP for Qualification of Analyst

OBJECTIVE 

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

SCOPE 

This SOP shall be applicable for the Qualification of Analyst in the Quality Control Department of PharmaInfo Limited. 

RESPONSIBILITY 

Execution – Chemist and above -QC Department 

Checking - Asst. Manager and above - QC Department

PROCEDURE 

• Identify approved Raw Materials and Finish products. 
• Keep the record i.e Name of analyst, material /product Name, Batch No./ A.R. No, Code No., test to be performed and the instrument used, analytical value of the sample with initial and present value etc as per Annexure – 2. 

• Assign appropriate code No. to each sample identified for qualification as, XX/NNN 

         Where:

             XX – AQ 

             NNN – Serial Number (For example 001). 

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• Give a sample for analysis appropriately coded in polybags/glass vials to the Analyst. 
• Provide detailed Standard Test Procedure to Analyst. 
• Evaluate the Analyst either two or more, in the 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 

• 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 

• 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 the Analyst shall be considered satisfactory if the results are reported by the Analyst. 

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

• Acceptance Limit for Qualification 

1. In the case of an 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 Materials and not more than 2% for Finished Products. 
2. In the case of Dissolution, compare the results with the previous result and the deviation between the two results (mean) should be in the range of ± 5% for that approved batch. 
3. In the case of IR analysis spectra shall match with Reference Spectra or with the IR spectra obtained from reference/working standard. 
4. Qualify each new Analyst before assigning the job of analysis in the area of work given to them. 

• After analysis collect all data for analysis and enter Batch no. / ARD No. of the given sample in Annexure - 1 
• Keep the details like calculations, chromatograms, and strip charts along with comments of the Department Head in the training file to be maintained separately for each Analyst. 
• Requalify the analyst if the results reported by the analyst do not pass the Acceptance Limit for Qualification. 
• A new sample is again given to the analyst with proper coding and repeat the above steps. 
• Do not allow subjected to work until he or she is qualified. 
• Maintain records related to Training / Re-training and Re-qualification in the training file. 

ALSO READ: Role and Responsibilities of Quality Control Analyst

ABBREVIATION

SOP: Standard Operating Procedure 

No.: Number 

IR: Infra-Red Spectrophotometer 

U.V.: Ultraviolet 

GLP: Good Laboratory Practices 

Asst. : Assistant 

HPLC: High-Performance Liquid Chromatography 

A.R. No. : Analytical Report Number 

RSD: Relative Standard Deviation

ANNEXURE

Annexure - 1: Qualification of Analyst 

Annexure - 2: Format for Detail Record of Analyst Qualification

REVISION HISTORY

Nil

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