The Technical feasibility report shall be prepared by analytical department and the detail of availability of the instruments, chemicals and reagents and technique shall be checked from of the respective product.
The analytical feasibility checklist is mentioned below -
1. Is Method of analysis available?
2. Is MSDS of API available?
3. Are the required safety controls available?
4. Are all the testing techniques available?
5. Are the Analysts trained for the type of technique?
6. Is Reference standard available?
7. Are impurities available?
8. Are all the equipment or column described in the method, available?
9. Are all the reagents and chemicals, used in the method, available?
10. Are all the consumables, used in the method, available?
11. Can the method be used to handle the expected load of samples in the QC within the required timeframe?
If answer to any one of the questions is ‘No’, then following should be done.
• Outsource the analysis or
• Carry out literature survey for finding an alternate method.
