Validation types are important for ensuring accuracy and reliability in data and information. There are five main types of validation used to verify data quality and integrity. This article will explore each type in an easy-to-understand way. Whether you’re a beginner or need a refresher, our guide will help you grasp the basics of validation types quickly and effortlessly.

What is Validation, and Why is it Important?

Getting Familiar with the Validation Process

Validation is the confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use are fulfilled. The concept of validation has expanded through the years to encompass a wide range of activities that should take place after product development and at the beginning of commercial production.

Prospective validation, the preferred approach, involves establishing documented evidence before process implementation, ensuring that a system performs as intended based on pre-planned protocols. This process includes the development of a Validation Plan, which then passes through the DQ, RA, IQ, OQ, and PQ phases, followed by instrument maintenance and re-qualification. Concurrent validation, on the other hand, generates documented evidence based on information generated during actual process use.

In cases of immediate and urgent public health need, validation may need to be conducted in parallel with routine production, and the product batches are typically quarantined until they can be demonstrated to meet specifications through QC analysis.

The Basics of Prospective Validation Explained

What You Should Know about Prospective Validation

Prospective validation is a crucial step in developing a new manufacturing process.

Here are some key points to know about it:

• The production process is divided into separate steps.
• Analyzing critical points like mixing times or temperature is important.

Prospective validation ensures that the process meets specific requirements before production starts.

This contributes to overall quality and safety and reduces the risk of defective products.

Examining critical aspects in advance can identify and adjust any potential issues before full production.

Steps in Prospective Validation

Prospective validation involves specific steps:

• Develop a Validation Plan.
• Pass through DQ, RA, IQ, OQ, and PQ phases.
• Perform process, computer, analytical, and cleaning validations.
• Prepare a final report.
• Subject instruments or equipment to preventative maintenance and re-qualification regularly.

Prospective validation establishes documented evidence before process implementation that a system works as intended. It’s important to remember not to start production until all validation activities are finished. Periodic reviews of instrumentation and equipment are necessary to identify any gaps. A remediation plan is developed if gaps are found, and the process restarts. The master validation plan may also address managing products produced during prospective validation.

Playing it Safe with Concurrent Validation

How Concurrent Validation Secures Your Processes

Concurrent validation is essential for securing processes. It confirms that manufacturing steps and critical points are effectively monitored during average production. A complete understanding of the process through prospective work is essential for concurrent validation. Intensive monitoring and assessment of manufacturing steps and critical points in the first three production-scale batches are necessary to ensure the process performs as intended.

Concurrent validation requires close and intensified monitoring of all manufacturing steps and critical points to ensure that the intended use requirements are being fulfilled. This type of validation is important as it offers assurance that the production process consistently meets specified requirements and helps identify any deviations that may affect the final result.

Concurrent validation plays a critical role in upholding the integrity and quality of the process by rigorously monitoring the process and testing the batches during the initial stages of production.

Important Elements in Concurrent Validation

Concurrent validation involves:

• Having a full understanding of the process through prospective work
• Intensified monitoring of all manufacturing steps and critical points in the first three production-scale batches
• Close examination of all process deviations and relevant investigation reports

This validation stage is crucial because it provides documented evidence that a facility and process will perform as intended. It ensures that processes are functioning as designed during normal production, boosting confidence in the quality and consistency of the final product.

Recognizing Different Stages of Process Validation

Stage 1: Planning Your Process Design

When planning your process design for validation, follow these key steps:

• Develop a Validation Plan.
• Proceed through phases like DQ, RA, IQ, OQ, and PQ.
• Perform various validations and generate a final report.
• Conduct preventative maintenance and re-qualification routinely.

To ensure your process design meets validation requirements:

• Follow the step-wise process.
• Perform all required validations.
• Maintain instrumentation and equipment periodically.

Potential risks or challenges during planning may include:

• Identifying gaps between previous qualifications and current requirements.
• Dealing with a product that needs to be scrapped or marked not for use/sale.
• Urgent public health needs may require parallel validation with routine production, which would involve managing product batches through quarantine until they meet specifications.

Stage 2: Qualifying Your Process

The process for validation involves several key steps:

1. Start the validation process before the product is produced.
2. Ensure all validation activities are completed before production.
3. Develop a Validation Plan.
4. Pass through phases including DQ, RA, IQ, OQ, and PQ.
5. Perform different types of validations.
6. Conduct Periodic Reviews to identify gaps and develop a remediation plan if needed.

Concurrent validation is essential because it provides real-time validation of the production process. It ensures that the product batches are quarantined until they meet specifications, guaranteeing the quality and safety of the final product.

There are different types of validation: prospective, concurrent, and retrospective. These types allow validation activities to be conducted at various stages, ensuring the product is safe, effective, and high-quality. Each type serves a specific purpose and contributes to the overall validation process.

Stage 3: Making Sure Your Process Stays Verified

To ensure a process stays verified, it’s important to consider five main types of validation: prospective, concurrent, retrospective, and periodic revalidation.

Prospective validation happens before production begins and involves proving that a system works as intended. Concurrent validation occurs during normal production to verify that the facility and process are operating as planned. Retrospective validation involves analyzing past production results to evaluate process consistency.

Periodic revalidation allows checking if the system still operates as initially validated and assessing any unintended changes. By using these types of validation and following a master validation plan (MVP), an organization can ensure the process stays reliable and effective over time, meeting regulatory standards and quality requirements.

Understanding the Different Types of Validation

Type 1: Looking Ahead with Prospective Validation

Prospective validation means ensuring a system works as it should before using it. This is important to avoid any problems during manufacturing. The steps for prospective validation include making a plan, then doing different phases like DQ, RA, IQ, OQ, and PQ. It also involves process, computer, analytical, and cleaning validations, and ends with a final report. After this, equipment needs regular maintenance and re-qualification.

Concurrent validation checks the process while it’s being used to ensure its proper operation. In urgent cases, validation might happen at the same time as production. Product batches might be held until they pass quality tests.

Type 2: Checking the Past with Retrospective Validation

Retrospective validation involves analyzing past production batches under the same conditions to check process consistency. It helps assess the stability and reliability of established products when prospective validation isn’t feasible.

This method includes conducting trend analysis on test results and reviewing process deviations. It ensures systems operate as initially validated without unintended changes affecting the process or equipment.

Key considerations for retrospective validation include periodic revalidation and close examination of manufacturing data for ongoing process consistency.

Type 3: Staying Current with Concurrent Validation

Concurrent validation helps ensure process security. It uses real-time data to show that the facility and process are working as intended.

During concurrent validation, it is important to closely monitor all manufacturing steps and critical points in the first three production-scale batches. Additionally, thorough testing and examination during normal production are necessary.

Concurrent validation differs from other types of validation, such as prospective and retrospective validation. It is conducted during normal production while products are being made, which sets it apart from the before—or after-production use of other types of validation.

Concurrent validation involves on-the-spot assessment and real-time evidence, unlike retrospective validation, which examines past production batches, or prospective validation, which involves upfront, comprehensive, pre-planned activities.

Type 4: The Importance of Doing it Again with Revalidation

Revalidation is important in process validation. It checks that all systems operate as originally validated and that no unintended changes have affected the process, system, or equipment.

It also ensures that the result remains consistent and meets the specified requirements.

When conducting revalidation, it’s essential to periodically review all instrumentation and equipment to identify gaps that may have developed since the last qualification.

If any gaps are identified, a remediation plan will be developed before starting the process again.

Revalidation contributes to maintaining the integrity of the process by ensuring that no unknown changes have affected the process or equipment. It also provides the safety, efficacy of the product, and the overall quality of the process.

Easy Examples of Process Validation

Creating Proof for Controlled Processes

Validation is vital for proving controlled processes. It gives evidence that specific requirements for a particular use are met. There are three main types of validation: prospective, concurrent, and retrospective. Prospective validation is about providing evidence before using a system to show that it works as intended. It includes making a plan, development, instrumental validations, cleaning validations, a final report, and routine maintenance.

Concurrent validation provides evidence based on actual process use. Sometimes, it’s done alongside routine production. Retrospective validation analyzes past production results to check process consistency. This includes looking at test results, process deviations, and investigation reports. The MVP also outlines how to manage products made during validation to ensure they don’t enter the supply chain.