Give details of validating document


After an introduction to the chapter’s approach for instrument qualification, this primer will lead you through individual qualification phases and give recommendations for implementation.



Checking the baseline noise of a detector and comparing the results with previously defined specifications would be an example for qualification.This is confirmed by typical statements such as this one that appears in the U. c GMP (current Good Manufacturing Practice) regulations: “Equipment shall be routinely calibrated, inspected and checked according to a written program to ensure proper performance” or by the more general requirement “Equipment should be suitable for its intended use”.Although there were lots of discussions about the approach for qualification of analytical instruments in the 90’s and in the early years of this century, this has changed since the USP has published the final version of the chapter Following a literature and regulatory overview, this primer will provide information on the entire qualification and validation process from planning, writing specifications as well as vendor qualification to installation, initial and on-going operation..There is a second aspect to why validation and qualification are important, and this is equally important for those working in a regulated and in an accredited environment.

Even though frequently not directly spelled out in regulations and official guidelines, such as Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), or in quality standards, such as the International Organization for Standardization (ISO) Standard 17025, validation and qualification is usually required.

Exact procedures and test parameters very much depend on the type of instrument and applications.