Analytical Procedures: Validation

Authored by: Joachim Ermer

Encyclopedia of Pharmaceutical Science and Technology

Print publication date:  July  2013
Online publication date:  July  2013

Print ISBN: 9781841848198
eBook ISBN: 9781351124874
Adobe ISBN:

10.1081/E-EPT4-v1-9

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Abstract

Analytical procedures are used throughout drug development, manufacturing, and release of drug substances and drug products. Important decisions such as establishment of the shelf-life from stability studies, the need for additional toxicological trials if new impurities appear or if known impurities exceed their qualified levels, and the reworking of batches and batch release or rejection are based on analytical results. Therefore, accuracy and reliability of analytical results are crucial for ensuring quality, safety, and efficacy of pharmaceuticals. Accordingly, the process to confirm that a method is suitable for its intended purpose, known as analytical validation has been in the regulatory focus for a long time. To provide consistent, worldwide regulatory expectations, the International Conference on Harmonization (ICH, (1)), has defined the validation process for release and stability testing of all new products in its second guideline within the Quality topic (2). This chapter interprets these ICH regulatory definitions and requirements, as well as provides direction towards rational and efficient validation.

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