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A REVIEW ON QUALIFICATION OF ANALYTICAL INSTRUMENT HPLC

  • Unique Paper ID: 163814
  • Volume: 10
  • Issue: 11
  • PageNo: 2086-2093
  • Abstract:
  • An essential foundation for the integrity and quality of analytical results in the pharmaceutical analysis is analytical instrument qualification (AIQ), which is a requirement for any analytical method validation. The Design Qualifying, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification phases of the qualification process are well- established (PQ). Different methods of analytical method validation are used, including prospective, retrospective, concurrent, and revalidation. The 4Qs model technique is used in the instrument qualifying process. Conceptual Qualification (DQ): Define the instrument's operational and functional requirements as well as any associated software requirements for the intended use. to be carried out prior to buying a new instrument. Installer Qualifying (IQ): Verify that an instrument is supplied in the manner in which it was intended and that it has been correctly installed in the environment of choice. To be carried out during system installation on new, old, or existing systems. A document that the instrument will perform in accordance with its operational specifications in the chosen environment. This is known as the operational qualification (OQ). A document that the instrument regularly performs in accordance with the specification and intended usage (performance qualification, or PQ). The Qualification of High-Performance Liquid Chromatography is another major emphasis of the current Review. The documentation ought to be supplied once the device has been qualified. The legality of needing process validation was determined by FDA regulatory experts. As a result, the validation is a crucial component of quality assurance.
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Cite This Article

  • ISSN: 2349-6002
  • Volume: 10
  • Issue: 11
  • PageNo: 2086-2093

A REVIEW ON QUALIFICATION OF ANALYTICAL INSTRUMENT HPLC

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