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Process Validation - Production Line Transferring to a Different Facility

B

Bigfoot

#11
#11
Keep Smiling said:
This is all great information, thank you for each response (the document is a great resource, chris1price).

Would Risk Assessment address "capacity analysis"? Waht should a capacity analysis look like?
Click to expand...

:2cents: IMHO I don't think that a Risk Assessment would fulfill / address capacity analysis. My belief is that Capacity Analysis should look at the Cycle time, availability, hours of operation, FTTQ, etc. Much like an OEE would do. :2cents: But this is my opinion only.

Good Luck and let us know the outcome.
 
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C

CliffK

#12
#12
Keep Smiling said:
This is all great information, thank you for each response (the document is a great resource, chris1price).

Would Risk Assessment address "capacity analysis"? Waht should a capacity analysis look like?
Click to expand...
I don't know if there are specific FDA requirements for capacity analysis.

Using a common-sense approach, you probably already have empirical data for actual line through put, including averages (monthly, weekly, whatever) and minimums and maximums.

So what about your new facility could change those numbers? How about things like material lead time changes caused by transportation, availability of utilities (some electric companies have much better availability numbers than others), suitability of work environment and infrastructure, worker knowledge, etc.

Some of those things you can probably quantify, others you can SWAG, some you can probably dismiss as factors.
 
J

Jojo.

#13
#13
Hi everyone,
In this case (Production Line Transferring to a Different Facility) what kind of validation it is? concurrent validation? or Revalidation?
Thank you!
 
K

kuyakut

Involved In Discussions
#14
#14
Jojo. said:
Hi everyone,
In this case (Production Line Transferring to a Different Facility) what kind of validation it is? concurrent validation? or Revalidation?
Thank you!
Click to expand...
Normally if equipment and ancillaries are the same , we conduct a revalidation but only IQ and PQ, we skip the OQ stage.
 
Last edited:
J

Jojo.

#15
#15
Thank you very much for your answer! :)
in our case it is indeed new equipments so a validation
Have a good day!
 
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#17
#17
A quick "bump" as there is a current process validation question and this is an excellent discussion.
 
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