by - PURPOSE:
To lay down the procedure for Analytical Chemist Validation.
- SCOPE:
This SOP is applicable to Analytical Chemist Validation to avoid the analytical errors during analysis in Quality Control Laboratory.
- RESPONSIBILITY:
Executive/Officer – Quality Control.
- ACCOUNTABILITY:
Manager – Quality Control.
- PROCEDURE:
- Analyst qualification is applicable in the following cases
- Qualification of new analyst.
- Qualification of regular analyst.
- All new analyst qualified before independently handling the analysis.
- Regular and new analyst qualification is conducted periodically by using unknown sample for Assay and regular approved sample for dissolution, related substances or other test and conformity of test results with standard specification as acceptance limit.
- Analyst qualification involves triplicate analysis of the same sample and conformity of the test results with acceptance limit.
- The unknown sample for Assay test to be prepared by using placebo of the required tablet, capsules or liquid for trainee analyst and trained analyst and give a code number for identity.
- The results compared and counter checked with the trained analyst test results/specification of the sample.
- Identify the sample to be tested (already approved), A.R. No., Acceptance limit and give a code number for identify.
- Sample is given to analyst in appropriately coded polythene bags/Glass bottles as applicable.
- The necessary information required for analysis of coded sample disclosed to the analyst.
- Analyst qualification shall include Assay, dissolution, moisture content and other physical parameters like disintegration test etc., as required.
- The qualification of
the analyst shall be assessed in terms of the following:
- Results are within the acceptance limits as per Table-1A and 1B.
- Analyst complies with Good Laboratory Practices.
- Document the results as per requirement.
- Analyst qualification is performed once in a year or as per the requirement.
- Record the analyst qualification record in formate.
- In case the analyst din not qualify; he/she shall be retrained and shall not be allowed for the subjected work till he/she is qualified for the task.
- The analyst qualification records are archived in Quality Control.
Table-1A
| Test | Acceptance criteria |
| Assay (by HPLC) | RSD NMT 2.0% Individual & within the group |
| Related substances (by HPLC) | RSD NMT 10.0% Individual & within the group |
| Absorbance (by UV) | RSD NMT 2.0% Individual & within the group |
| Water (by KF) | RSD NMT 2.0% Individual & within the group |
| Test | Acceptance criteria |
| Assay (by Titrimetry) | RSD NMT 2.0% Individual & within the group |
| Specific Optical Rotation (by Polarimeter) | RSD NMT 2.0% Individual & within the group |
| Physical parameters like DT, pH & Moisture Content | RSD NMT 2.0% |
Table-1B
In case of Assessment by RSD (Relative Standard Deviation), as applicable, follow the table as below:
| Sr. No. | % of Active ingradient | Test | RSD Limit |
| 1 | ˃100mg | Assay | 1 |
| 2 | 10-100mg | Assay | 2 |
| 3 | 1-10mg | Assay | 3 |
| 4 | ˃1mg | Assay | 4 |
Note: Relative Standard Deviation limits are In-House
7.0 REFRENCE:
In House.
