Process Validation: How Many Sample Sizes do I Need?

Process validation is becoming ever more important within regulated and non-regulated industries. Process validation is a term to indicate that a process has been put to such scrutiny that the result of the process (a product, a service or other outcome) can be practically guaranteed. Regulatory and certification bodies, like the FDA and ISO, have requirements for the validation of processes.

When performing process validation, the question most frequently asked is “How many do I need?”. The answer is “it depends”. Depends on what?

In this article, Mark Durivage answers this question, explaining that there are several factors that must be considered when determining the appropriate sample size, including risks associated with the product, costs associated with producing the product, and costs associated with inspection, measuring, and testing.