Process Validation as defined by the FDA is “The collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.”
- To ensure that the design, process, and products are created in a manner to prevent loss of life and harm.
- To produce safe parts for their intended use.
- To reduce part rejection rates.
- To ensure that the part meets the application requirements, specification, and regulatory obligation.
- To prevent part failures in the field.
The PTI Validation Process
- Designate a multi-functional hands-on team that will collaborate throughout the validation process.
- Define the requirements and plan the approach — evaluate the design, product, and cater a validation plan based on application and risk.
- Identify product outputs and acceptance criteria for form and function.
- Identify and describe the necessary processes and equipment.
- Create a validation master plan – otherwise known as an MVP, CVP, or master protocol.
- Develop the validation processes and any other necessary documentation.
- Perform the validation processes.
- Maintain and verify the validated state during the production process.
- Revalidate — required when equipment changes, a process deviation occurs, and on a periodic basis (such as annual equipment and software revalidations).
PTI’s advanced precision inspection and testing abilities address a spectrum of dimensional and functional product specifications and requirements. Our capabilities support comprehensive inspection actions ranging from receiving to final audit, as well as first article layouts, full AIAG PPAP and IQ, OQ, PQ Process Validation Submissions.
Learn more about the Life Cycle of Validation and review our white papers on this topic
Team PTI has been featured online in the Medical Product Outsourcing website. You can learn more about their role with Molding Validation Optimization – A Medtech Makers Q & A.