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Master Thesis

L’approche cycle de vie de la validation des procédés de fabrication pharmaceutiques : l’implémentation du suivi en continu des procédés à un produit historique

Abstract : Traditionally, process validation concerns the 3-batch pre-marketing stage and attest the robustness of the process to produce a drug product to the expected quality requirements. ln 2011, the Food and Drug Administration published the guideline "Process Validation: General Principles and Practices" which redefines process validation and introduces the life cycle approach. Process validation becomes a continuous process divided into three phases: process design, process qualification and finally continuous process verification.The FDA guideline is based on the ICH guidelines Q8, Q9 and Q1 o. lndeed, it uses the methodology of Quality by Design of ICH Q8, the risk management of ICH Q9 and the life cycle vision of quality of ICH Q1 O. This thesis focuses on the life cycle approach especially on the third phase of continuous process verification and its implementation on legacy products. American and European regulatory authorities stipulate that continuous process monitoring concerns all drugs, even those with a long history of marketing, known as "legacy product". The challenge is to implement concepts brought by the life cycle approach to these products.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-03564231
Contributor : Jean-Hugues Morneau Connect in order to contact the contributor
Submitted on : Thursday, February 10, 2022 - 11:58:07 AM
Last modification on : Saturday, February 12, 2022 - 3:46:48 AM
Long-term archiving on: : Wednesday, May 11, 2022 - 6:30:53 PM

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  • HAL Id : dumas-03564231, version 1

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Adrien Escoubès. L’approche cycle de vie de la validation des procédés de fabrication pharmaceutiques : l’implémentation du suivi en continu des procédés à un produit historique. Sciences pharmaceutiques. 2022. ⟨dumas-03564231⟩

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