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Master Thesis

Système de revue des validations de méthodes analytiques : application aux substances actives d’un site fabricant de matières premières à usage pharmaceutique

Abstract : Quality Control is a key area of the pharmaceutical industry which contribute to ensure the quality, the security and the efficacy of the medicines put on the market as part of a larger system of quality assurance. Analytical methods are the basic element of this area which make it possible to carry out such checks. Analytical validations ensure that these methods meet the requirements of their usual daily routine. They fit in a much-regulated context. This regulation and the technologies evolving, it becomes necessary for industries to fit into a more in-depth assessment of the analytical validations with the periodic evaluation of this validations. Currently, these validations are not regulated. It is therefore appropriate for the company to put them in place with their own goals, the regulation of the analytical validations and their internal procedures. The first part of this document attempts to recontextualize the role of the analytical validations in the pharmaceutical industry, their essential regulatory prerequisite and to present tools to implement an effective review on an industrial site, the presentation of the methodology for an individual review and an example of an associated action plan.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-02328133
Contributor : Frédérique Gambade <>
Submitted on : Wednesday, October 23, 2019 - 10:15:36 AM
Last modification on : Friday, October 23, 2020 - 4:56:46 PM
Long-term archiving on: : Friday, January 24, 2020 - 2:42:32 PM

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  • HAL Id : dumas-02328133, version 1

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Hugo Magrin. Système de revue des validations de méthodes analytiques : application aux substances actives d’un site fabricant de matières premières à usage pharmaceutique. Sciences du Vivant [q-bio]. 2019. ⟨dumas-02328133⟩

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