I got into an interesting conversation with a coworker and was looking to get feedback and other’s insight on this issue:
My coworker was expressing to me that there is no regulation to qualify secondary packaging equipment (as they do not add additional tamper evident) and therefore cartoner do not need validation. However, he proceed to say that during the packaging qualification they would include the cartons.
My question to him was how did you know the operations ranges of the cartoner during process qualification if it was never OQ?
Please feel free to comment on why you think secondary packaging should or should not be qualified.
No guidelines is saying that secondary packing equipments doesnot require qualification.
as QUALIFICATION includes checking of physical condition of main components,matching specifications of critical parts like blister magazine w.r.t design spec.,instruments calibration,checking safety features functionality and the most important thing is to challenge the machine for different speeds w.r.t design.
based on this we can conclude and establish the critical paramters of the equipment without any discrepancies.
dear sir,
i am facing problem in convincing the auditor about the difference between online and off line conductivity of purified water . online it is 0.4 -0.45 while off line it is coming around 1.2-1.3 which is border line as per USP at 25°C
please revert
rajeva jain
[quote=rajevajain]dear sir,
i am facing problem in convincing the auditor about the difference between online and off line conductivity of purified water . online it is 0.4 -0.45 while off line it is coming around 1.2-1.3 which is border line as per USP at 25°C
please revert
rajeva jain[/quote]
What is the problem? What is one being used for verus the other? When the system was validated what were the limits and how do they compared to the data gather during the validation?