Leveraging previous results in IQOQs - Environmentally Controlled Room

Candi1024

Quite Involved in Discussions
#1
We are attempting to write an IQOQ for an already installed environmentally controlled room. There has been extensive testing already completed by an outside contractor, using tools that we don't have at our disposal.

We would like to write the protocol to show that all the testing has been completed and passed. However protocols must be written before the testing has been completed.

Suggestions?
 
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Ninja

Looking for Reality
Trusted Information Resource
#2
We are attempting to write an IQOQ for an already installed environmentally controlled room. There has been extensive testing already completed by an outside contractor, using tools that we don't have at our disposal.

We would like to write the protocol to show that all the testing has been completed and passed. However protocols must be written before the testing has been completed.

Suggestions?
Questions that "suggest suggestions"...

1) Why does the protocol have to be written first?
1a) Or if you mean "targets for performance"...didn't you have them before you spent the cash?

2) What performance do you need (IOW what did you try to buy?)
If testing is expected to be better than this, simply document what you need.

It is typical to not really know what you need until you try out your new room...what do you think you need, best guess?

3) are you trying to "pass", or are you trying to reach a certain level?
If all you need to do is "pass"...simply double the range on all expectations.
Not sure what value this would have technically...but it would have some political weight if you're into that sort of thing.

4) Again, if what you need is "pass" rather than achieving a defined objective limit, the words "Approximately" and "Target" and "Nominal" are useful for writing a document that doesn't say anything.

We work in a field that tends to have objective values and measurable limits...from your question it sounds like you are trying to achieve something else...??? Or did I totally misread your question? (It happens).
 

yodon

Staff member
Super Moderator
#3
That's a tough one. Quite a few holes that could be poked into any story you could come up with.

Was the testing done to a particular standard; i.e., what was the success criteria?

Was the equipment used properly calibrated and proper for the measurements taken?

Was your service provider qualified and approved?

Did they supply a report or are you having to re-assemble the results?

Has everything contributing to the environmental control of the room been properly qualified (so even if the data from the service provider 'passes' how do you assure it wasn't just a one-time thing)?

Probably more to consider but those immediately jump out.
 

Candi1024

Quite Involved in Discussions
#4
That's a tough one. Quite a few holes that could be poked into any story you could come up with.

Was the testing done to a particular standard; i.e., what was the success criteria? Yes, ISO standards

Was the equipment used properly calibrated and proper for the measurements taken? Yes, but they didn't record the equipment used or proof of calibration

Was your service provider qualified and approved? Let's assume Yes

Did they supply a report or are you having to re-assemble the results? We have a certificate of compliance for a clean room to ISO standards.

Has everything contributing to the environmental control of the room been properly qualified (so even if the data from the service provider 'passes' how do you assure it wasn't just a one-time thing)? We continually monitor humidity and particle count. We also have them come in a recertify every year.

Probably more to consider but those immediately jump out.
Thinking that it was certified to ISO standards does help. Being that the standards were created before the test.

The reason the protocol must be written first, is that the FDA is always suspicious of fudged numbers. They like to see the acceptance criteria determined first, then the testing done.
 

shimonv

Trusted Information Resource
#5
Hi Cani1024,
Unfortunately, QA work often consists of plastering activities...


I can think of two options:
1. [tricky but short] reconstruct a protocol based on original emails, meetings and phone calls, and put an earliyer date to the protocol. Both you and the outside contractor will need to sign on it.
2. [clean but long]open a CAPA for the missing protocol and follow your CAPA process. By way of correction you will reconstruct a protocol and evaluate the suitability of the results you already have. You should be able to use post-market data to support your conclusions...

Cheers,
Shimon
 
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