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Testing, Commissioning, Validation, Qualification, or Verification? A Brief History

In the good old days, when I was a field service engineer, I tested things.  Anything I didn’t test, usually came back to bite me.  A piping & instrumentation diagram and electrical/pneumatic schematics, along with a good highlighter, were typically all that was needed to ensure that everything was tested and that a working system was turned over to the client.  Of course this method of testing requires a certain level of experience; a butterfly valve that only opens 75% of the way, or a perfectly running motor with the wrong rotation shouldn’t pass the test.   Drawings do not point this out, you just have to know. In addition, the only documented evidence that the testing was performed was my highlighted and scribbled upon schematics. 

Many professional organizations improved upon this simple testing model with a more formal commissioning program.   However, the commissioning process rarely included quality assurance in the loop and the quality of the effort relied solely upon the professionalism of the maintenance and engineering departments.  Once commissioning was completed, documents were usually locked away forever in a back room and not subject to inspection by auditors.

As FDA compliance expectations for the pharmaceutical industry increased throughout the 1990’s, the industry used what tools it had.  Namely, the validation process (IQ/OQ/PQ), created in the late 1970’s in response to the FDA’s increased scrutiny on parenteral products.  So a methodology developed for filling and terminal sterilization processes, was now being applied all the way down the line; including, equipment, utilities, facilities, and software for everything from in-vitro diagnostics to API. 

Of course, this one-size fits all approached caused issues as well.  Validation is an approach meant to document that a complex, dynamic system is in statistical control.  It does not always apply well to engineering or automated systems that behave the same way every time. To address this disconnect, the PQ was often dropped and everything was considered validated once the PV was run. PQ/PV wound up meaning different things to different people, depending on the system under scrutiny and the facility. In response to this confusing state of affairs, the pharmaceutical industry moved from validation to qualification for equipment, utilities and facilities. Qualification was meant to address that fact that equipment, utilities and facilities are not processes.  To put it another way, you qualify the car and validate traffic patterns.

In the 21st century, commissioning and qualification (C&Q) became the gold standard for ensuring equipment, utilities and facilities were in FDA compliance with GMP requirements. However, the industry was still using the same IQ, OQ, PQ hammer to accomplish commissioning and qualification activities. Quality assurance was brought into the commissioning process, as well as the qualification process.  C&Q of equipment, utilities and facilities was getting, repetitive, time-consuming, and expensive. Something had to be done!

The risk based approach was co-opted around 2004 to deal with spiraling C&Q costs. The idea was to use risk assessments to target C&Q activities and to streamline the C&Q process. The actual outcome was the polar opposite. The documents required to qualify a simple reactor ballooned to include URS, FRS, pFEMA, and a risk assessment.  Now a validation plan and trace matrix were needed just to keep track of it all!

I’ll continue the story or the risk based approach and eventually ASTM E2500 in the next blog post. 


Nels Hackl

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