What Points To Be Considered Before Analytical Method Validation?

1.	What Points To Be Considered Before Analytical Method Validation?
Answer» Test method is "ready" for validation. Method development should not occur at this time. If there is a need for continued method optimization, your method is NOT ready for validation. Analyst must be qualified, has DEMONSTRATED proficiency and clearly understand how to perform a method validation. Instruments/Equipment is in a "qualified state." Materials is in qualified state (i.e samples, standards, impurities ETC.. should have proper COA.) Protocol to be prepared and APPROVED by concerned QUALITY and MANAGEMENT departments.

Answer»

Test method is "ready" for validation. Method development should not occur at this time. If there is a need for continued method optimization, your method is NOT ready for validation.
Analyst must be qualified, has DEMONSTRATED proficiency and clearly understand how to perform a method validation.
Instruments/Equipment is in a "qualified state."
Materials is in qualified state (i.e samples, standards, impurities ETC.. should have proper COA.)
Protocol to be prepared and APPROVED by concerned QUALITY and MANAGEMENT departments.

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