Closed and Completed Validation Package


If you have a closed and completed validation package, and the system
is in production and you discover something that was missed in
validation document review and has to be clarified.

You draft a clarification memo- can you add this new memo to the closed package and only update your documentation index? Or should memos of this
type not go back into the validation package, but, in another file

Curious as to what other pharmas have done in this situation.



A validation of a system is never finished. If this is the concept
then you will find yourself sometime down the line with a
non-validated system.

The validation package is a living set of activities and documents.
Thus, if you have updates - include them in the package and be sure
that th package reflects the current state of the system.

As a matter of fact it is a good practice to review and update
documents like the URS and its derivatives and consequences all the
way through to testing scripts based on the accumulated changes
control requests.

Best regards,

Frank, can you clarify exactly what the missed something was? I certainly agree with Graham that validation is never really done - there’s always ongoing maintenance, changes, etc. that would require some level of re-validation.

In your case, though, depending on what the thing missed was, maybe there are different approaches? For example, was it a requirement missed (not shown to be verified)? Was it test results that were interpreted incorrectly (possibly leading to a situation where the system was really not meeting requirements?

Hi yodon,

Yes there were 2 reuirements missed at the FS stage that were in the URS.
Hence we have to go back update the FS,RTM and include 2 extra testing steps in the IQ protocol.


I would definitely add it to the validation package. You found the mistake and corrected it. FDA is ok with this. A good investigator would likely find it and if you’re open about it and show you addressed it with full control, you should be ok.

Dear All,
validation is on going activity, it never end up, validation is a live science study, Once the system/ process is validated then the revalidation either periodical revalidation or after change re validation concepts are appeared,


There is a correct method for adding something that was omitted and it certainly is not by adding anything to protocols that are signed off. There is a standard pharmaceutical industry method that has been in use for many years.

It is by raising a Supplementary (IQ, OQ or PQ), and treating it as you would, a new IQ, OQ or PQ.
In this SIQ (for instance) you give your justification for raising the protocol along with a rationale on the implications of it being required.
Because this action (test or inspection) was not in the original protocol, so the original system/equipment was never verified as being compliant for this requirement. Was there a risk that this could have produced or allowed to be produced, damaged product.
If there was a risk to the product, what have you done about product that was produced prior to this supplementary validation verification.
These points need to be rationalised and justified in the introduction chapter in your Supplementary Protocol.
I went into a plant and found the validation protocols so poor, that I had to rewrite over 100 iq/oq/pq’s. All were done as supplementary protocols.
The regulator held that the original documents (although crap) were approved company protocols and applied to product that was produced when they existed and so could not be simply discarded.
Ensure you have traceability by cross referring original and supplementary. Do it properly and it really is no big deal, regulators, generally do not give you a hard time for sorting out your own mistakes, as long as your efforts are genuine and honest. Deliberately fudge it, and they will crucify you.

Alex Kennedy

Thanks Alex, great points


I’m curious why an SIQ is used and not just a revision (with complete change control, etc.) on the protocols? I only have experience on the device side but we’ve revised IQs, OQs and PQs before (on previously-qualified systems) and the FDA didn’t raise an eyebrow. I don’t see any problems with an SIQ - other than what happens if you need a “second supplement” (or a third). With revisions, you don’t have to create new document “lines.” Could be I’m just naive about the pharma side.