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January 19, 2024, vizologi

Real-World Examples of Process Validation

Products and services are always changing, making process validation more critical than ever. Process validation is seen in many industries, from manufacturing to healthcare. It’s used to ensure the safety and effectiveness of drugs and the quality of car parts. Looking at real-world examples helps us understand the significance of process validation today.

Understanding How We Make Sure Products Work Right

Explaining What it Means to Check Products

To ensure products are correctly made in the MedTech industry, it’s important to follow key steps. Process verification and validation are crucial in providing consistent and correct production. It’s essential to understand the differences between these steps and know when to use each in medical device manufacturing.

Keeping records of product checks and quality control measures is essential to meeting ISO 13485:2016 and 21 CFR 820.75 requirements and establishing centralized Quality Management Systems (QMS).

Following process validation steps, such as IQ, OQ, PQ, and process risk analysis, is essential to meet predetermined specifications and ensure that a process consistently produces the expected results. Additionally, documentation is vital for additional sterilization validation procedures to confirm that a product meets its intended results.

Explaining How We Make Sure Products Are Made Right

During the planning and design stage, specific steps are taken to ensure products are made correctly. This includes conducting a risk analysis to identify potential failure or quality issues.

Additionally, design verification and validation activities are carried out to confirm that the product design meets the specified requirements and user needs.

Determining to check products or ensure they are made correctly throughout the production process is based on established checkpoints and predefined criteria. This involves conducting in-process inspections, testing, and monitoring at various stages to verify that the product is being manufactured as required.

Process validation, product testing, and inspection protocols are implemented to ensure every product is thoroughly checked for quality before release. This includes conducting final product inspections to assess conformance to quality standards and regulatory requirements and verifying that the product meets customer expectations before it is cleared for release.

Deciding When to Check Products or Make Sure They’re Made Right

Determining when to check products is essential. Consider the stage of the process and the intended result. In the development process, ensure outcomes meet the specified requirements (Design Input). For sterilization, verify that the product is sterile. Factors to consider include the need for objective evidence that the process consistently produces a result meeting its predetermined specifications. This evidence confirms the fulfillment of requirements for a specific use.

Not checking products can have profound implications, such as inconsistent production impacting the quality and safety of medical devices.

The Steps to Making Sure Products Are Made Right

Stage One: Planning and Design

Some critical decisions are made during the planning and design stage for product quality. These include figuring out how the product will be used and the requirements. It also involves deciding on the specific process that needs to be checked to ensure quality. This stage helps define the process and its intended results. It also helps identify important process factors and acceptance criteria.

Additionally, it sets the stage for deciding how and when to check the products. This includes methods like installation qualification, operational qualification, performance qualification, and risk analysis. The complexity of the process, its criticality, and the impact on safety and effectiveness influence when and how to check the products.

Stage Two: Testing a Sample Product

During Stage Two of the product development process, specific methods and criteria are used to test a sample product. One method used is the Master Validation Plan (MVP) form, which outlines the stages of process validation. These stages include Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and process risk analysis.

Stage Two aims to ensure that products are made right by establishing a process that consistently produces a result meeting predetermined specifications, as defined by the FDA. Critical considerations for deciding when to move a product to the next stage or modify the sample product based on testing results include understanding the scope of the procedure, having a centralized Quality Management System, meeting ISO 13485:2016 and 21 CFR 820.75 requirements, and addressing the requirements for sterilization validation.

Stage Three: Checking Every Product

Stage Three involves specific processes and procedures to validate every product. This includes conducting IQ, OQ, and PQ processes for every product. By implementing these procedures, consistency and accuracy in checking every product is achieved, ensuring its quality and performance.

Any discrepancies or issues found during the checking process are addressed by conducting a thorough process risk analysis. This involves following the outlined process validation procedure, SYS-014, per ISO 13485:2016 and 21 CFR 820.75 requirements.

Understanding the process validation steps is essential, as they allow you to rectify any discrepancies or issues found during the checking process.

Where You Should Keep All the Records

In the MedTech industry, product planning, design, testing, and checking records should be stored in a centralized Quality Management System. This ensures that all needed documentation is easily accessible for review and audit. Properly organizing and storing records can also help oversee product quality control processes more efficiently by easily tracking changes, updates, and approvals.

This is especially important for process validation to ensure consistent production of correct results. Best practices for maintaining the confidentiality and security of product records include access controls, regular backups, encryption of sensitive data, and keeping an audit trail of all changes. Following these best practices ensures that product records are secure and comply with industry regulations.

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