Glossary Term
Process Validation
Definition
Process validation is the documented evidence that a manufacturing process consistently produces a product that meets predetermined specifications and quality standards. It is a critical step in ensuring that a manufacturing process is capable of consistently producing products that are safe, effective, and reliable. In the medical device industry, process validation ensures that the manufacturing processes used to produce devices, components, or finished products comply with regulatory requirements, such as those set by the FDA or ISO 13485, and that they consistently meet quality control standards.
Relevance to the MedTech Industry
Process validation aims to confirm that the processes used in manufacturing are well-controlled, reproducible, and capable of consistently producing high-quality products. This reduces the risk of product defects, ensures compliance with regulatory standards, and enhances product safety and efficacy. Process validation is essential to ensure that all aspects of production—from raw material sourcing to final assembly—are consistent, reliable, and meet the required specifications.
Additional Information & Related Terms
Key Components of Process Validation
Installation Qualification (IQ):
Installation qualification verifies that the equipment, systems, or processes are installed correctly and according to the manufacturer’s specifications. This ensures that the equipment will function as expected and meet regulatory standards.
Example: Verifying that a sterilization chamber is installed correctly and meets the specifications needed to sterilize medical devices.
Operational Qualification (OQ):
Operational qualification tests the equipment or processes to confirm that they operate according to predefined criteria and that they can perform within the specified range. This ensures the process will consistently deliver the intended results.
Example: Testing the sterilization chamber to ensure that it operates within the correct temperature and pressure range to achieve effective sterilization.
Performance Qualification (PQ):
Performance qualification ensures that the equipment or process consistently produces the desired product at the required quality level. This involves validating the process under actual working conditions to confirm that it performs as intended in a real-world setting.
Example: Running the sterilization cycle with medical devices to confirm that it meets all specifications for sterilization effectiveness and quality.
Statistical Process Control (SPC):
Statistical process control involves using statistical methods to monitor and control the manufacturing process. This ensures that the process operates within specified limits and any variations are detected early, allowing for corrective actions to be taken.
Example: Using control charts to monitor the temperature and humidity levels during the production of injectable drug devices to ensure that the conditions stay within acceptable limits.
Change Control and Revalidation:
When changes are made to the manufacturing process, such as the introduction of new equipment or materials, the process must be revalidated to ensure that it still meets quality standards. A formal change control process ensures that any adjustments to the process are reviewed and validated.
Example: A new material is introduced into the manufacturing process, and the entire process is revalidated to ensure that the final product still meets safety and performance standards.
Related Terms
Quality Control (QC): A process that ensures that the products manufactured meet predefined quality standards. It works alongside process validation by inspecting and testing products to detect defects and ensure compliance.
Good Manufacturing Practice (GMP): A set of guidelines and regulations that ensure products are consistently produced and controlled according to quality standards, often part of the process validation process.
Design Verification: The process used to confirm that a product meets the design specifications, often part of the overall product development process before validation begins.
Lean Manufacturing: A methodology that focuses on reducing waste and improving efficiency, often used in conjunction with process validation to ensure that manufacturing processes are streamlined and effective.