Do we really need process validation? ABSOLUTELY!

My last blog on design verification and validation triggered a lot of comment and response. In fact, some of you started bringing process validation into the discussions. Related to FDA definitions of terms, 21 CFR 820 defines process validation as:

“(z)Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

(1)Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

While both the FDA and ISO require process validation, it is something we should all do regardless of the requirements because it’s just good business. Some might say it is “cheap insurance.” Essentially, validating the processes and performing characterization of the product or specific manufacturing steps can help avoid waste and unnecessary scrap during the manufacturing processes. When processes have been properly characterized and those steps that are critical to quality have been identified, there is a much higher probability the product can be manufactured correctly the first time. Industry standard would suggest that it costs three times as much to have to repeat a process or recall a product than it does to make it properly the first time. 

The FDA’s Medical Device Quality Systems Manual: A Small Entity Compliance Guide gives the following examples of when process validation is the only practical means for assuring that processes will consistently produce devices that meet predetermined specifications:
•   “Routine end-product tests have insufficient sensitivity to verify the desired safety and efficacy of the finished device
•   Clinical or destructive testing would be required to show that the manufacturing process has produced the desired result or product.
•   Routine end-product tests do not reveal all variations in safety and efficacy that may occur in the finished devices
•   The process capability is unknown, or it is suspected that the process is barely capable of meeting the device specifications.”
Lot-to-lot (or system-to-system variability) can be dramatically reduced with appropriate process validation techniques. You might look at the manufacturing processes for instruments/hardware as you would the process of cutting cookies. Ideally, you want each piece/instrument to be identical (or close) to each other. The purpose of validating processes such as that is to eliminate the need and extra cost of 100% inspection.

When looking at a biologic or reagent type of product, you could look at it as if you are making spaghetti sauce. It is never exactly the same twice in a row. Yet, if you added too much garlic or too much oregano, you couldn’t eat the sauce. The key to this example and process validation in general is the appropriate characterization of Critical To Quality (CTQ) steps, and setting the correct parameters.

I strongly recommend the FDA document “Small Entity Compliance Guide” to help put this topic, as well as others, into plain English perspective. Below are two links for reference.

FDA Small Entity Compliance Guide – Process Validation
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Postm...

FDA Small Entity Compliance Guide:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Postm...

About the Author
B. Christine Park is a quality systems consultant with expertise in the implementation and remediation of sustainable and regulatory compliant quality systems.  She can be contacted at 678-480-5411 and cpark928@mindspring.com a target="blank" rel="nofollow" href="/redirect?url=http%3A%2F%2Fwww%2Eenkap%2Ecom%2Fprofiles%2Fblog%2Fcpark928%40mindspring%2Ecom&urlhash=7HMo&_t=tracking_anet">http://www.enkap.com/profiles/blog/cpark928@mindspring.com>

Related
Content Package Available from the FDA Compliance Learning Community of enKap
Process Validation Content Power Package
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