Tipos de validación en la industria farmacéutica: guía

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.

Tipos de validación en farmacia

1. Validación del proceso

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. Validación de la limpieza

De este modo se garantiza que los métodos de limpieza eliminan eficazmente los residuos, contaminantes o microorganismos de los equipos para evitar la contaminación cruzada. La validación de la limpieza es especialmente importante en las instalaciones multiproducto.

3. Validación del método analítico

Verifica la precisión, especificidad, reproducibilidad y solidez de los métodos utilizados para probar productos farmacéuticos. Para este proceso se exige el cumplimiento de la norma ICH Q2(R2).

4. Validación del equipo

Confirma que el equipo funciona de forma coherente dentro de los parámetros requeridos y respalda la producción de productos de calidad. Incluye fases de cualificación como la cualificación del diseño (DQ), la cualificación de la instalación (IQ), la cualificación operativa (OQ) y la cualificación del rendimiento (PQ).

A menudo, los términos cualificación y validación se utilizan conjuntamente. Sin embargo, en la fabricación de productos farmacéuticos sirven para fines distintos.

- La cualificación se centra en garantizar que los equipos, sistemas o instalaciones funcionan como se espera. Incluye actividades como la cualificación del diseño (DQ), la cualificación de la instalación (IQ), la cualificación operativa (OQ) y la cualificación del rendimiento (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.

Esta distinción es crucial para comprender los pasos necesarios para garantizar la calidad del producto y el cumplimiento de los requisitos normativos.

Las etapas de la validación de procesos

La validación en la industria farmacéutica suele seguir un planteamiento sistemático:

• ‍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.

La importancia de un enfoque sistemático

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 validación y su papel en la garantía de calidad

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.

Entorno normativo

Los requisitos de validación se basan en normativas como las Buenas Prácticas de Fabricación vigentes de la FDA (descubra por qué son importantes las BPF), las directrices de la Agencia Europea de Medicamentos (EMA) y las directrices del Consejo Internacional de Armonización de Requisitos Técnicos para Productos Farmacéuticos de Uso Humano (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 necesidad de una validación continua

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.

Retos y consideraciones

La validación puede ser compleja, y algunos de los retos son la integración de nuevas tecnologías, la adaptación a la evolución de la normativa y la gestión de los costes asociados a las actividades de validación.

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.

‍