Process validation is an important part of both FDA regulations and ISO 13485. It comes into play when a company cannot, or does not, perform 100% verification of the process output. Typically, process validation is required when the verification is destructive. The trend has shifted, however, to cases where sampling plans verify the process output.
This slide deck explains the fundamental requirements for process validation in both FDA QSR and ISO 13485. It explains when a process should be validated, the basic components of a process validation (IQ, OQ, and PQ) and how to write protocols and reports. It includes some FDA Warning Letters to help understand the requirements and explain the current status of the FDA Guidance Document as it relates to medical devices.