Do We Really Have to Validate? Really??

Actually, no, you don’t.  But you might want to know what the conditions are.  First, you need to know the difference between validation and verification.  Let’s review how FDA defines validation.  From FDA's Guidance for Industry, Process Validation:  General Principles and Practices

“…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.”

The message here is that validation is something that you do now that allows you to make a statement about your manufacturing process.  More than that, you can continue to make that statement as long as the process doesn’t change.  So, if you validate a process, you can make a prediction about the future.

Let’s compare that with verification.  Here’s how the Global Harmonization Task Force (GHTF)* said in January 2004 in - Quality Management Systems - Process Validation Guidance, GHTF Study Group 3, defines verification

“Verification is confirmation by examination and provision of objective evidence that the specific requirements have been fulfilled.”

As you can see verification is an activity that is done now that assesses whether certain specifications ‘have been’ fulfilled in the past.  It is a backwards looking activity.

How can we use this information to decide whether validation is necessary?  FDA says in 820.75 Process validation:

(a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.

This means that if we can fully verify the results of a process, then we do not have to validate it.  An example would be a fabrication process with simple dimensional specifications.  The requirement is that every specification for every product part has to be verified.

If every specification for every part cannot be verified, then the process must be validated.

*GHTF is an organization composed of representatives of the regulatory agencies of the major industrial nations.