Analytical Instrument Qualification (USP 1058)
Q1: What is Analytical Instrument Qualification?
Ans:Analytical Instrument Qualification:
It is the process of
ensuring that an instrument is suitable for its intended application.
Ans: Qualification of the instrument is an essential part of the validation. For a successful validation, usage of pre-qualified instruments is must. The results or data obtained from the qualified instruments is reliable, accurate and gives the true picture of the validation at different stages. Qualified instruments play a major role in validation activities. They are considered the back bone of validation.
Validation in fact applies to manufacturing processes, analytical procedures & software procedures.
Instruments are thus qualified and not validated, in fact they are the pre-requisites for a successful validation program.
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