SOP for Evaluation of Analyst’s Performance

1.0 OBJECTIVE

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

2.0 SCOPE

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

3.0 RESPONSIBILITY

3.1 Doing: Executive/Manager
3.2 Checking: Manager

4.0 ACCOUNTABILITY

Head of the 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 the analyst.
5.5 Provide detail method of analysis to the analyst.
5.6 Evaluate the analyst either one or more of 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. Microbiology

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

1. HPLC
2. U.V. spectrophotometer
3. Titration
4. I.R. Spectrophotometer

5.7 Evaluate the capability of the analyst in terms of its precision to perform the tests and GLP followed by the analyst.
5.8 The capability to perform tests by analyst shall be considered satisfactory if the results reported by the analyst.

a. Are within the acceptable limits.
b. The analyst complies with GLP.
c. Documents the results as per requirement.
5.9 Qualify each new analyst within three months of the area of work given to them.
5.10 Keep the details like calculations, chromatograms, strip chart along with comments of the department head in training file to be maintained separately for each analyst.

5.11 In case of analyst found not qualified, retrain the analyst and do not allot subjected work until he is qualified.
5.12 Maintain records related to training /retraining and requalification in training file.
5.13 Prepare the final report.

6.0 ABBREVIATIONS

6.1 B.No. = Batch No.
6.2 I.R = Infrared spectrophotometer
6.3 U.V = Ultraviolet
6.4 GLP = Good laboratory practice

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