SOP FOR ANALYST VALIDATION

1. OBJECTIVE:

1. To lay down the procedure for Analyst Validation.

2. SCOPE: 

1. This procedure is applicable for Analyst Validation in Quality control laboratory .

3. RESPONSIBILITY:

1. Quality Control Officer / Executive are responsible to follow procedure as per the procedure mentioned in this SOP. 

2. QC Head is responsible for implementation and compliance of the procedure as per this SOP.

4. ABBREVIATIONS

1. SOP    :    Standard Operating Procedure

2. QC    :    Quality Control

3. HPLC    :    High Performance Liquid Chromatography

4. RSD    :    Relative Standard Deviation

5. NMT    :    Not More Than

6. RT        :    Retention Time

5. PROCEDURE: 

1. Analyst Validation is applicable in the following cases:

1. Validation of the new analyst.

2. Validation of the regular analyst

2. All new analysts will be qualified before independently handling the analysis.

3. Regular analyst Validation is conducted periodically by using previously approved sample or against trained analyst and conformity of test results.

4. Analyst Validation involves triplicate analysis of the same sample three times and conformity of the test results with acceptance limit. The result shall be compared and counter checked with the original test results or against trained analyst.

5. Identify the sample to be tested (already approved), AR No., Acceptance Limit and give a code number for identity.

6. Sample shall be given to analyst in appropriately coded polythene bags/Glass bottles as applicable.

7. The necessary information required for analysis of coded sample shall be disclosed to the analyst.

8. The Validation of analyst shall be assessed in terms of the following  :

1. Results are with in the acceptance limits.

2. Analyst complies with GLP practices.

9. Analyst Validation should perform once in a year or as per the requirement.

10. Incase the analyst did not qualify, he/she shall be retrained and shall not be allowed for the subjected work till he/she is qualified for the task. If chemist fails repeatedly then he/ she will be transferred to other department.

11. All analyst Validation records are archived in Quality Control.

12. Analyst validation is required only for main instruments.

13. Acceptance Criteria For Assay

1. Acceptance limit of RSD of RT and Area should be NMT 1.0%.

2. Result obtained by analysis should not vary more than 2.0% to actual result for result up to 70% and 1.0% for result more than 70%.

3. RSD for three RT and Area should NMT 1.0%.