Olika typer av validering inom läkemedelsindustrin: en 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.

Olika typer av validering inom läkemedelsindustrin

1. Validering av process

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. Validering av rengöring

Detta säkerställer att rengöringsmetoderna effektivt avlägsnar rester, föroreningar eller mikroorganismer från utrustningen för att förhindra korskontaminering. Validering av rengöring är särskilt viktigt för anläggningar som tillverkar flera produkter.

3. Validering av analysmetod

Verifierar noggrannhet, specificitet, reproducerbarhet och robusthet hos metoder som används för att testa farmaceutiska produkter. Överensstämmelse med ICH Q2(R2) krävs för denna process.

4. Validering av utrustning

Bekräftar att utrustningen fungerar konsekvent inom de parametrar som krävs och stöder produktionen av kvalitetsprodukter. Detta inkluderar kvalificeringssteg som designkvalificering (DQ), installationskvalificering (IQ), operationell kvalificering (OQ) och prestandakvalificering (PQ).

Ofta används begreppen kvalificering och validering synonymt. De hade dock olika syften inom läkemedelstillverkning.

- Kvalificering fokuserar på att säkerställa att utrustning, system eller anläggningar fungerar som förväntat. Detta inkluderar aktiviteter som designkvalificering (DQ), installationskvalificering (IQ), operationell kvalificering (OQ) och prestandakvalificering (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.

Denna distinktion är avgörande för att förstå de steg som krävs för att säkerställa produktkvalitet och efterlevnad av lagstadgade krav.

Stegen i processvalideringen

Validering inom läkemedelsindustrin följer vanligtvis ett systematiskt tillvägagångssätt:

• ‍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.

Vikten av ett systematiskt tillvägagångssätt

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

Validering och dess roll i kvalitetssäkringen

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.

Den regulatoriska miljön

Kravet på validering grundas på bestämmelser som FDA:s Current Good Manufacturing Practices (se varför GMP är viktigt), Europeiska läkemedelsmyndighetens (EMA) riktlinjer och International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) riktlinjer.

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.

Behovet av kontinuerlig validering

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.

Utmaningar och överväganden

Validering kan vara komplicerat, och några av utmaningarna är att integrera ny teknik, anpassa sig till nya regelverk och hantera de kostnader som är förknippade med valideringsaktiviteter.

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.

‍