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ABSTRACT
This article presents an example of a quality-by-design approach used in the development of a solid oral dosage form, integrating the risk-based approach. The latter consists in identifying risk situations for each attribute or process parameter and analyzing them for their probability of occurrence, consequences and detectability, so as to establish associated risk levels, and allow appropriate conditions and a suitable control strategy to be implemented.
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Read the articleAUTHORS
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Jean-Jacques HOURI: Ph.D., Chief Hospital Engineer - Assistance Publique-Hôpitaux de Paris, Agence Générale des Équipements et Produits de Santé, Département affaires réglementaires, pharmaceutiques et médicales, Paris, France
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Mélisande BERNARD: Pharmacist PH – Université Paris Sud, UFR de Pharmacie, Groupe matériaux et santé, Châtenay-Malabry, France - Assistance Publique-Hôpitaux de Paris, Agence Générale des Équipements et Produits de Santé, Département de contrôle qualité et développement analytique, Paris, France
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Hassane SADOU-YAYE: Pharmacist, Université Paris Sud, UFR de Pharmacie, Groupe Matériaux et Santé, Châtenay-Malabry, France - Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Pitié-Salpêtrière, Service de Pharmacie, Paris, France
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Bernard DO: Pharmacist MCU-PH – Université Paris Sud, UFR de Pharmacie, Groupe Matériaux et Santé, Châtenay-Malabry, France - Assistance Publique-Hôpitaux de Paris, Agence Générale des Équipements et Produits de Santé, Département de Contrôle Qualité et Développement Analytique, Paris, France
INTRODUCTION
Taking a simple case such as an immediate-release oral solid tablet, containing a class 2 active substance with low solubility and high permeability according to the Biopharmaceutical Classification System (BCS), we propose to study a hypothetical pharmaceutical development based on a Quality by Design (QbD) approach incorporating systematic risk analysis. Eventually, the approach adopted in this example could be generalized to other pharmaceutical forms where appropriate.
The development of a new pharmaceutical form involves several stages, four of which are essential:
formulation of the pharmaceutical form;
development of the manufacturing process ;
the transposition of the previously developed process;
validation of the commercial process.
The aim of this development should be to obtain a robust formulation and a manufacturing process driven by a control strategy guaranteeing the performance qualities of the pharmaceutical form when it is marketed.
The approach based on strict adherence to the process defined during the development of the pharmaceutical form and quality control verifying compliance with predefined specifications has shown its limits in terms of product quality control. Pharmaceutical manufacturing processes evolve throughout their life cycle, in response to optimization needs and/or the need to comply with new regulatory requirements. In this example, we'll see that integrating risk analysis into an optimized control strategy can reduce the number of end-of-pipe controls and improve the quality guarantees for the pharmaceutical form in question.
A glossary at the end of the article lists the main acronyms used.
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KEYWORDS
quality risk management | pharmaceutical development | quality by design | solid oral form | new pharmaceutical form
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Drugs and pharmaceuticals
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