Evaluation of Analyst’s Performance in Pharmaceuticals SOP

Standard operating procedure to Evaluate the Performance of Analyst (Analyst Qualification). 

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1.0 OBJECTIVE:

To lay down a procedure for evaluation of analyst’s performance. 

2.0 SCOPE:

This procedure is applicable for qualification of analyst in quality control dept.

3.0 RESPONSIBILITY:

3.1 Doing: Executive/ Manager.

3.2 Checking: Manager.

4.0 ACCOUNTABILITY:

4.1 Head of the Q.C Department.

5.0 PROCEDURE:

5.1 Identify approved raw material and finish product and prepare a list.

5.2 Keep the record of material/ product name, B. No., A.R. No., code no. and analytical value of sample along with acceptance limit.

5.3 Assign appropriate code no. to each sample identified for qualification.

5.4 Give sample for analysis appropriately coded in poly bags/ glass vials to analyst.

5.5 Provide detail method of analysis to analyst.

5.6 Evaluate the analyst either one or more of following areas of analysis.

    5.6.1 Assay (analysis to be carried out in triplicate).

    5.6.2 Dissolution.

    5.6.3 Identification by IR spectrophotometer (analysis to be carried out in triplicate).

    5.6.4 Microbiology.

5.7 Evaluate the analyst for one or more of the following analytical method.

    5.7.1 HPLC.

    5.7.2 U.V spectrophotometer.

    5.7.3 Titration.

    5.7.4 I.R spectrophotometer.

5.8 Evaluate the capability of the analyst in terms of its precision to perform the tests and GLP followed by the analysts.

5.9 The capability to perform tests by analyst shall be considered satisfactory if the results reported by the analyst.

    5.9.1 Are within the acceptable limits.

    5.9.2 The analyst complies with GLP.

    5.9.3 Documents the results as per requirement.

5.10 Qualify each new analyst with in three month of the area of work given to them.

5.11 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.

5.12 Maintain records related to training/ retraining and requalification in training file.

5.13 Prepare the final report. 

 

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