Purpose
This SOP describes the procedure for
Analyst Qualification which are working in Analytical Development Lab.
Procedure:
- Every analyst shall be qualified in their respective working area prior to assigning the responsibility individually, viz. Chemical analysis, Instrumental analysis.
- Before starting analyst qualification, Manager, ADL/Designee shall ensure that the analyst is trained in Chemical analysis and instrument handling.
- All instruments to be used for analysis shall be within calibration due date and the solutions/ reagents to be used shall be within their expiry date.
- Analytical methods, which are to be used in analysis, shall be validated or official in pharmacopeia.
- The sample to be provided for qualification shall be previously or parallel analyzed by competent personnel with same operating conditions like instruments, reagent solutions, working standards and other environmental conditions.
- Manager,
ADL/Designee
shall
decide the sample and test method for analyst qualification.
- Manager,
ADL/Designee
shall
give the analyst the sample with test protocol and the method of analysis.
- Analyst shall perform the testing on the sample provided as per method of analysis in triplicate, including all solution preparation.
- The test results obtained and the summary of results shall be recorded in the analyst qualification protocol.
- All relevant data e.g. analysis report, chromatograms, raw data shall be attached to the analyst qualification protocol.
- Manager,
ADL/Designee
shall
review the report obtained along with the report from the parallel analysis
done by competent analyst.
- The acceptance criteria for analyst qualification shall depend upon the nature of individual test carried out.
- If the results obtained are not within the acceptable limits, then more training shall be imparted and re qualification shall be done.
- Frequency for re-qualification of the analyst shall be done after once in two years or in case of Out of Specification (OOS) investigation shows analyst error.
- After
completion of the analyst qualification the activity shall be recorded in the
analyst qualification protocol.