temperatures exceeded the limits during the packaging process validation? what should I do?
The short answer is “fail the test.”
I presume, though, you are really wondering what the impact is. Unfortunately, that depends on a number of factors. You (the company) needs to assess the impact on quality that the out-of-range temperature condition has. It may well be your specs were too tight and the temperature is just fine. It may also be that you have non-conforming product as a result and so your process is not properly controlled.
You’ll need to find out who set the temperature spec, why it was set there, and what the impact of the condition is. Presumably, you have a Validation Master Plan or something similar that describes the process you are to follow when a test failure occurs. Be sure to follow that!
If you can be more specific as to the conditions, results, etc., we might be able to provide better help.
story is as follows. During the process of packing machine operator blister pack, keep a record of the process. Packing wrote in a report that the temperature was set by it. After the settlement of the production of the report goes to the technologist and he’s aware of this without doing accepting these overruns. Now I’ve done these validations and I had exceeded and would like to cease this precedent. what should I do? today we did and we assessed the risk of RA, the findings need to open the deviation and change control for new limits established during the PQ. whether the idea of a good site? how to write a protocol PQ?
Sounds like a bit of a mess and I’m not sure I completely follow.
It sounds like you did a production run and the qualified parameters for temperature were exceeded. On the surface, there are a number of problems I see that should be addressed. At least 1 CAPA needs to be managed. Based on the number of problems, there are likely numerous root causes.
There was a failure on the line for not catching the problem.
Someone accepted the product without recognizing a process parameter was exceeded (either due to it not being correctly recorded or just overlooked).
The equipment did not stay within the validated range.
The product, I believe, should be quarantined. A thorough assessment of impact should be done and documented to determine disposition. If you decide to release the product then you’ll have the rationale documented why you believe it’s safe.
If you decide the parameters can be extended, you will need to re-validate the process / re-qualify the equipment. In light of #3 above, it sounds like even if you widen the temperature range, you don’t have a guarantee that the equipment will stay within the desired range.
Hope that helps.