What is the maximum permissible period of delaying the validation of equipment?

Mohammed Gouda

Involved In Discussions
#1
Dear all,

I face a problem in my the validation plans that the plan can't be applied properly due to some affairs...And it may be shifted or delayed for a period may reach up to 1 month.

The question is :
"What is the maximum permissible period of delaying the validation of equipment?"

Best Regards,
M.Gouda :bigwave:
 
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somashekar

Staff member
Super Moderator
#4
Dear all,

I face a problem in my the validation plans that the plan can't be applied properly due to some affairs...And it may be shifted or delayed for a period may reach up to 1 month.

The question is :
"What is the maximum permissible period of delaying the validation of equipment?"

Best Regards,
M.Gouda :bigwave:
There is nothing like what you are looking for ...
1. Are you producing parts from that process ?
2. Has it been an old and known process all along and now you want to validate and document ?
OR
3. Is this a new process being established and no parts being produced are put to actual use ?
OR
4. Is this a new process being established and parts are already being turned out for use ?

If 1. and 2. are YES, please plan and execute asap
If 1. and 3. are YES, take whatever time you deem fit to validate
If 1. and 4. are YES, STOP. Validate and establish procedure
 
Last edited:
M

MIREGMGR

#5
I agree with Somashekar's decision process.

You don't indicate what regulatory system applies to the production process. US FDA is very clear on the timing of validation after a process change; it must be done before production commences. FDA's wording is less definitive on validation of new processes, but it's implied that they must be validated prior to production.
 
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