Nello sviluppare metodi HPLC, i punti da tenere in massima considerazione
The points to be considered concerns validation, documentation and regulatory compliance issues.
• How to adapt, qualify and modify USP methods
• How to validate methods in ways that will minimize method transfer problems
• How to develop a robust HPLC method and fulfil the FDA’s requirements in the QC operations in pharmaceutical , biotechnology and related industries
• How to avoid unpleasant “surprises” during validation
• How to avoid regulatory problems with FDA or EPA during audits
• Consider the FDA’s New Millennium Directives, cGMP, and the Guidance for analytical methods validation.
Helps to these questions can obtained from VQI (ValQual International)