Tuesday, September 18, 2018

Process Verification / Validation

An answer to a query:

Ques:  The  company  (site) that I work for, manufactures intermediate products.  The question that we have is-If a change is made to a process,  should we do validation or is verification sufficient?  All our processes have QC/acceptance criteria.  For example, we got a validated instrument from another site (of our company).   We got IQ/OQ done by the vendor at our site.  We also have the same instrument from another vendor, which will be retired in couple of months.  Can we do verification of the new instrument by writing a technical report ?    In other words, we will  first conduct  a risk assessment and then do experiments to compare the data of the two instruments and record them in a report.  Actually we have already done feasibility studies to show that the new instrument gives the same data as the old one for the same samples .  I heard , in your talk that FDA doesn't require validation if we have the means for 100% checking.  We have similar situations in which we sometimes make a change in the process but we always have means to verify the final product because we have acceptance criteria in place.  Is verification enough for such situations?    Please advise.

Ans:  "FDA doesn't require validation if ..."  The specific reference for my comment for medical device manufacturing is 820.75 "Process validation, (a) "where a 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..."  The key exception to this is automated (computerized) processes, which per 820.70(i) must be validated no matter what.

As to the rest of your question, part of the answer depends upon your definitions of verification and validation, technical report, feasibility studies, et al.  Any change requires some level of verification (testing, checking, feasibility studies, etc), or a series of verifications (part of a validation) to prove that the change does what it should and doesn't do what it shouldn't.  While I won't state what you've outlined will satisfy requirements (though on the surface it appears to), if you've satisfied the CGMPs and what I've outlined above, yielding data that nothing has changed and that product quality / specifications are assured after the changes per your data, documented, then you've met the requirements.