483 Process Validation - FDA Audit Observation

  • Thread starter Elizabeth Rafferty
  • Start date
E

Elizabeth Rafferty

#1
Good morning all

We recently had an FDA inspection which resulted in a 483. One of the observations was:

Procedures for monitoring and control of process parameters for a validated process have not been established.

Specifically, no process validation procedures have been established.

As we always verified 100% of our product, we did not have an established procedure. We recently developed an in-house software system for use by our manufacturing staff. It was validated, but we didn't have a procedure in place before the validation describing the validation process.

Does anyone have a good process validation template I can use?

Thank you.
 
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yodon

Staff member
Super Moderator
#2
Maybe it's because it's late in the day but I'm not connecting the dots.

When I see "monitoring and control of process parameters" I think of things like weld temperatures, dwell times, etc. So I the description of the 483 and your statement about no process validation procedures have been established make sense.

Even if you test 100% of your product, there may be processes during production that can't be 100% verified; e.g., gluing, soldering, etc. So maybe that's a hint.

Here's where I wasn't able to connect: you then say you have an in-house software system used by your manufacturing staff and it was validated but you didn't have a procedure in place. To me, this sounds like a separate issue; i.e., your overall Quality System does not address process OR computer software validation.

So maybe the specific finding was different from the lack of general controls?

To answer your last question, I expect that if you search on "Validation Master Plan" (or "Master Validation Plan" or VMP or MVP), you'll likely get some hits or at least some additional ideas.

Does that help?
 
E

Elizabeth Rafferty

#3
Sort of...........we do have validation procedures for software when it's product, but not for software we use. Unfortunately, this is an over-sight on our part. We validated our in-house software as we validate the software we sell. This is okay, but because it's not product, but part of our process, we are required to have a different procedure in place.

Thanks for your input; I will do another search with your suggestions.
 
T

TommmD

#4
Did you get far in looking for a template? I'm in a similar position insofar as not having process validations documented, but have not yet been thru an audit. My plan(!) is to validate new fixtures as they become available to kick-start the effort. What I found on the clinivation site was OK, but only moderately helpful. Very posssibly only because of my unfamiliarity with it.

Tom


Sort of...........we do have validation procedures for software when it's product, but not for software we use. Unfortunately, this is an over-sight on our part. We validated our in-house software as we validate the software we sell. This is okay, but because it's not product, but part of our process, we are required to have a different procedure in place. .

Thanks for your input; I will do another search with your suggestions
 

v9991

Trusted Information Resource
#5
Good morning all

Procedures for monitoring and control of process parameters for a validated process have not been established.

Specifically, no process validation procedures have been established.

As we always verified 100% of our product, we did not have an established procedure.
I sugges that you need to "verify/confirm you assumption that 100% verified product/process need not be validated!!!":confused:
I guess you are aware of the context of product/process validation, validation involves, extensive study of the process& product to establish/confirm that it delivers the intended&consistent quality.

Further the product&process controls could be done to verify that product/process is inline with that which is validated.

We recently developed an in-house software system for use by our manufacturing staff. It was validated, but we didn't have a procedure in place before the validation describing the validation process.

Does anyone have a good process validation template I can use?

Thank you.
This is to do with validation/qualification of software tools. Which would be different from that of the process/product validation;:caution:

Request you to clarify the context of the auditor-comments; such that we can precisely provide you some inputs.

Hope that helps.
 
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