Addendum to the Protocol

What items would be significant to the Addendum? In brief, our qualification did not meet some of the Acceptance Requirement and Corrective Actions are in place.

How should exactly the Addendum to the protocol be stated?

Were the failures due to the acceptance criteria or true failures that required changes to the system?


Good point to discuss,

I have one query, is addendum qualification is acceptable by Regulatory?.
In which cases we can perform the addendum qualification?.

I have a case here" One of the cold room got breakdown and New compressor installed as part of CAPA, whether i have to requalify the Cold room or just prepare a addendum protocol and perform temperature mapping then close it?.

Your thoughts may helpful.


R.Dasaratharami reddy

as the cold room that you are stating has broken down completely and a new compressor has been installed, i feel that a revalidation is required. The reason for a revalidation is because your initial validation documents would have captured the specification of the currently faulty compressor.
Addendum protocol will not be sufficient, however if you can give a brief about your organization policy for introducing an addendum protocol then i may be able to help you further.


duirng review of approved validation documets, if any minor deviations / mistakes observed, then we can go for addendum to the main document with proper justification. where in cold room breakdown case, we have to go for revalidation (can be use of same protocol) and new report to be prepared.

Better to have a sop on addendum preparation, where to define the procedure