ABSTRACT
All relevant data collected during validation and formulae used for calculating validation characteristics should be submitted and discussed as appropriate.
Approaches other than those set forth in this guideline may be applicable and acceptable. It is the responsibility of the applicant to choose the validation procedure and protocol most suitable for their product. However, it is important to remember that the main objective of validation of an analytical procedure is to demonstrate that the procedure is suitable for its intended purpose. Because of their complex nature, analytical procedures for biological and biotechnological products in some cases may be approached differently than in this document.
