Types de validation dans l'industrie pharmaceutique : un guide

Validation in the pharmaceutical industry is a critical procedure that ensures the safety, quality, and efficacy of drugs. Required by regulatory bodies such as the FDA, EMA, and WHO, validation is a cornerstone of pharmaceutical manufacturing, offering documented evidence that processes operate as intended. This article will define pharmaceutical process validation and its practical applications in the pharmaceutical industry.

How to define pharmaceutical process validation?

Validation in the pharmaceutical industry is the process of generating documented evidence that a specific procedure, process, or activity consistently leads to the expected results. It is essential for ensuring product safety and compliance with guidelines such as ICH guidelines for process validation and WHO guidelines for validation.

Pharmaceutical process validation is not just about meeting legal requirements; it is a proactive quality assurance measure that prevents issues like cross-contamination and product failure, thereby protecting public health and maintaining trust in pharmaceutical products. There are different types of pharmaceutical process validations, which we will elaborate further on.

Types de validation dans l'industrie pharmaceutique

1. Validation du processus

This type confirms that the manufacturing process produces outputs that meet predefined specifications. It is conducted in three stages: process design, process qualification and continued process verification. This is a fundamental requirement outlined in FDA’s Current Good Manufacturing Practices (cGMP).

2. Validation du nettoyage

Cela permet de s'assurer que les méthodes de nettoyage éliminent efficacement les résidus, les contaminants ou les micro-organismes de l'équipement afin d'éviter toute contamination croisée. La validation du nettoyage est particulièrement importante pour les installations multi-produits.

3. Validation de la méthode analytique

Vérifie l'exactitude, la spécificité, la reproductibilité et la robustesse des méthodes utilisées pour tester les produits pharmaceutiques. Ce processus doit être conforme à la norme ICH Q2(R2).

4. Validation des équipements

Confirme que l'équipement fonctionne de manière cohérente selon les paramètres requis et contribue à la production de produits de qualité. Cela comprend les étapes de qualification telles que la qualification de la conception (DQ), la qualification de l'installation (IQ), la qualification opérationnelle (OQ) et la qualification des performances (PQ).

Les termes qualification et validation sont souvent utilisés l'un pour l'autre. Cependant, ils ont servi à des fins différentes dans la fabrication de produits pharmaceutiques.

- La qualification vise à garantir que les équipements, les systèmes ou les installations fonctionnent comme prévu. Elle comprend des activités telles que la qualification de la conception (DQ), la qualification de l'installation (IQ), la qualification opérationnelle (OQ) et la qualification des performances (PQ).

- Validation in pharma, on the other hand, has a broader scope. It ensures that the entire process, including equipment, systems, and methods, consistently produces a product meeting predefined quality standards.

Cette distinction est essentielle pour comprendre les étapes nécessaires pour garantir la qualité des produits et le respect des exigences réglementaires.

Les étapes de la validation des processus

Dans l'industrie pharmaceutique, la validation suit généralement une approche systématique :

• ‍Design qualification (DQ): this initial step ensures that the proposed design of the equipment or process meets the requirements for the intended purpose.

• Installation qualification (IQ): in this phase, it is confirmed that the equipment or systems are installed correctly and according to the manufacturer's recommendations.

• Operational qualification (OQ): here, it is determined whether the systems and equipment operate according to the intended operating ranges.

• Performance qualification (PQ): the final step involves testing that the equipment consistently performs according to the process parameters and can produce the desired output.

L'importance d'une approche systématique

A systematic approach to validation is crucial because it helps identify potential variability in processes and establishes measures to control these variables. This is not just about ticking off a compliance checklist; it's about guaranteeing the quality and consistency of life-saving drugs in qualitative healthcare packaging. This includes ensuring secure and tamper-evident solutions such as blister packs for medication, which protect dosage integrity and enhance patient safety. That's why EcoBliss is your partner in healthcare packaging

La validation et son rôle dans l'assurance qualité

Validation is an integral part of Quality Assurance (QA) in the pharmaceutical industry. It is a proactive measure that identifies potential problems before they affect the final product. It is a preventive approach rather than a reactive one, saving companies from costly recalls and maintaining their reputation.

L'environnement réglementaire

L'exigence de validation est fondée sur des réglementations telles que les bonnes pratiques de fabrication actuelles de la FDA (découvrez pourquoi les BPF sont importantes), les lignes directrices de l'Agence européenne des médicaments (EMA) et les lignes directrices du Conseil international pour l'harmonisation des exigences techniques relatives aux produits pharmaceutiques à usage humain (ICH).

Validation in the pharmaceutical industry in action

To bring the concept of validation to life, let's look at a real-world application. In a packaging context, consider the Locked4Kids Wallet Box: a child-resistant solution. Before this innovative packaging hits the market, it undergoes rigorous testing and validation to ensure it meets safety standards while being accessible to adults. This kind of validation includes tests to verify that the packaging is tamper-evident, durable, and functions as intended. For example, the testing was to see how fast both children and seniors could open the Wallet Box. The system proved difficult to open for children, while seniors could open it with ease.

La nécessité d'une validation continue

Validation in the pharmaceutical industry is not a one-time event but a continuous process. As new data are gathered, processes might be refined, and validation activities will be carried out again to ensure continuous compliance and quality. Validation in pharma is therefore viewed as an ongoing activity throughout the entire product lifecycle. After initial validation, processes must be continuously monitored using data from routine production to confirm that they remain in a state of control. This ongoing approach enables manufacturers to detect trends, deviations, or potential risks at an early stage and to take timely corrective or preventive actions. Regulatory authorities such as the FDA and EMA expect this lifecycle-based validation strategy, as it supports Good Manufacturing Practices, strengthens process understanding, and ultimately helps safeguard consistent product quality and patient safety.

Défis et considérations

La validation peut être complexe, et certains des défis à relever comprennent l'intégration de nouvelles technologies, l'adaptation à l'évolution de la réglementation et la gestion des coûts associés aux activités de validation.

It is a vital part of the pharmaceutical industry's commitment to delivering safe and effective products and a dynamic process that requires attention to detail, a thorough understanding of processes, and a commitment to quality. Understanding the importance of validation is essential for anyone involved in the pharmaceutical industry, from the lab to the boardroom.

Want to discuss how a robust validation process can be implemented for your pharmaceutical products? Do not hesitate to reach out. Our team is ready to provide expert guidance and support, ensuring your products meet the highest standards of quality and safety.

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