Hi All,

I believe that Both the FDA and ISO have established similar requirements when it comes validation. The FDA requires process validation if the process cannot be fully verified by inspections or test. Some Manufacturers use In-line inspection methods, or visual systems to avoid conducting process validation. Some other manufacturers validate their processes to avoid the costs associated with 100% inspection or when 100% inspection is not feasible.

In my opinion, ISO is providing manufacturers with a less restrictive requirement. ISO is letting the manufacturers decide on their best process verification/validation strategy. If the manufacturer is capable of coming up with an innovative approach to replace full verification, then the manufacturer is not required to validate the process.

– Fady Khalla