Medical Device Manufacturing Process Validation

The guideline on "General Principals of Process Validation" was issued in May 1987, and since then, medical device companies have struggled with the principals of process validation. Successfully validating a process may reduce the dependence upon intensive in process and finished product testing. Due to the complexity of today's medical products, routine end product testing alone is often not sufficient to assure product quality for several reasons. Some end product tests have limited sensitivity. In some cases, destructive testing is required to show that the manufacturing process is adequate. In certain situations end product testing does not reveal variations that may occur in the product, which may impact safety and effectiveness.

21 Code of Federal Regulations (CFR) Part 820.75 states that:

Validation Services Provided: