SOP Title: Validation of Analysts in Quality Control Department
- Objective:
To lay down the procedure for Validation of Analysts in Quality Control Department.
- Scope:
This SOP is applicable for Validation of Analysts in Quality Control Department.
- Responsibility:
- Quality Control: To prepare and review the SOP. To follow the procedures laid down for Validation of Analysts in Quality Control Department as per this SOP.
- Quality Assurance Department: To review and approve the SOP and Annexures.
- Accountability:
Head Quality Control Department, Head Quality Assurance Department
- Procedure:
| 5.1 | Validation of Analysts: | |||||||||
| 5.1.1 | New appointed analyst should go through all the relevant SOP training before starting actual job. | |||||||||
| 5.1.2 | After completion of SOP training, Analyst should complete analyst Validation for Complex and Non-complex tests before performing routine testing. | |||||||||
| 5.1.3 | Supervisor/Group leader shall allocate approved or routine sample to the analyst for analyst validation based on type of test i.e. Complex test or Non-complex test. | |||||||||
| 5.1.4 | In case of Complex test, approved /already tested sample shall be given for analyst validation. | |||||||||
| 5.1.5 | In case of Non-complex test, routine /under test or approved sample shall be given for analyst validation. | |||||||||
| 5.1.6 | For distinguishing of Complex and Non-complex test refer below table but not limited to; | |||||||||
Complex Test:
|
||||||||||
Non-complex Test:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||
| 5.1.7 | Note:
● If the analyst is qualified for any one of the test above marked then the analyst can be considered qualified for rest of the tests of same marked. |
||||||||||||||||||||||||||||||||||||||||||||||||||||
| 5.1.8 | ► If the analyst is qualified for any one of the test above marked then the analyst can be considered qualified for rest of the tests of same marked. | |
| 5.1.9 | # If the analyst is qualified for any one of the test above marked then the analyst can be considered qualified for rest of the tests of same marked. | |
| 5.1.10 | * If the analyst is qualified for Heavy Metal or Arsenic any one of the test then the analyst can be considered qualified for the tests above marked. | |
| 5.1.11 | For complex test, analyst shall give the request for AWR pages to QA Department as per test before initiating the testing. | |
| 5.1.12 | For issuance of AWR refer SOP “Control of Documents, Preparation, Approval, Issuance and Maintenance. | |
| 5.1.13 | After getting AWR from Quality Assurance, new analyst shall initiate the testing with online documentation under the observation of trained analyst. | |
| 5.1.14 | For Non-complex test, analyst can report all the preparation and results directly on regular AWR sheet issued by Quality Assurance Department. | |
| 5.1.15 | Analyst shall fill required details in “Analyst Validation and Evaluation Record” concurrently as per Annexure. | |
| 5.1.16 | If routine/under test sample results found out of specification limit then initiate investigation as per OOS SOP. | |
| 5.1.17 | Trainer shall monitor new analyst during testing and write observations in analyst validation and evaluation record. | |
| 5.1.18 | Trainer/Group leader has to write conclusion, whether analyst shall be qualified or not qualified based on results obtained and acceptance criteria. | |
| 5.1.19 | If new analyst fails to meet acceptance criteria of analyst validation, then Trainer/Supervisor shall investigate the cause of failure and recommend for analyst revalidation with re-training. | |
| 5.1.20 | Analyst should follow Standard Test Procedure and specification during testing. | |
| 5.1.22 | Acceptance criteria for standard replicate injections shall remain same as defined in standard test procedure. | |
| 5.1.23 | If New analyst qualified for Assay By HPLC then analyst shall be considered qualified for Assay by UV/AAS/GC. Same criteria are applicable for rest of the tests. | |
| 5.1.24 | Analyst should fill the ‘Analyst Validation Log Sheet’ after completion of validation records and certification as per Annexure. |
- Definitions / Abbreviations:
- Definitions :
- Abbreviations :
| Abbreviation | Expansion |
| No. | Number |
| AWR | Analytical Work Record |
| HPLC | High Performance Liquid Chromatography |
| GC | Gas Chromatography |
| AAS | Atomic Absorption Spectroscopy |
| OOS | Out of Specification |
| UV | Ultra Violet |
*Note – Ready to use SOP available in “DOWNLOAD” Section.