JJLit

Starting to get Involved
#1
I work for a medical device company that is ISO 13485 registered. Being a smaller company, we outsource most of our manufacturing. We do cleaning and sterile barrier packaging in house. The equipment that is used has been in place for about 8 years or so, which predates my employment here by about 6 years.

During our yearly ISO audit last year, the auditor made a couple of observations regarding us not having procedures for IQ, OQ, and PQ. Also, an observation was made regarding us not having a Validation Master List.

Does anyone have samples or a template for developing these procedures? Also, I can't seem to find out exactly what a Validation Master List is. I have searched here and other places. Since the validations have taken place years ago, how does an IQ, OQ, PQ philosophy apply to me now?

Thanks in advance for any help.
 

achorste

Inactive Registered Visitor
#2
The GHTF has a guidance document regarding process validation. I have also attached our procedure for Product / Process Validation (stripped of the company detail of course).

This may help - I only ask that you refrain from copy & pasting the whole procedure verbatim.
 

Attachments

GStough

Staff member
Super Moderator
#3
I work for a medical device company that is ISO 13485 registered. Being a smaller company, we outsource most of our manufacturing. We do cleaning and sterile barrier packaging in house. The equipment that is used has been in place for about 8 years or so, which predates my employment here by about 6 years.

During our yearly ISO audit last year, the auditor made a couple of observations regarding us not having procedures for IQ, OQ, and PQ. Also, an observation was made regarding us not having a Validation Master List.

Does anyone have samples or a template for developing these procedures? Also, I can't seem to find out exactly what a Validation Master List is. I have searched here and other places. Since the validations have taken place years ago, how does an IQ, OQ, PQ philosophy apply to me now?

Thanks in advance for any help.
Could it be that the auditor was suggesting a list or matrix of the machines that have been validated with dates of validation that could be used for re-validation when necessary? If so, this can be something as simple as a Word or Excel table listing the machine ID #/name, function, date of validation, protocol used, person(s) involved in the validation, etc.

As for the IQ, OQ, and PQ procedures, wouldn't they be necessary or at least helpful for future machine validations, even if they don't necessarily apply to you at this time? Just a thought.

Hope this helps. :bigwave:
 
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Ajit Basrur

Staff member
Admin
#4
Hi JJLit,

My friends, achorste and Gidget have given you the right answers and have left nothing for me to input :tg:

Btw, we have lot of info on IQ, OQ and PQ in the Cove - did you use the SEARCH function ?
 

JJLit

Starting to get Involved
#5
Thank you all for the quick and informative responses. And also thanks for the sample docs. That does give me a starting point.

Yes I do agree that we need procedures for future equipment/process validations. I don't have a problem with that and now I have some sort of a starting point to develop those. I did search the Cove and did some Googling but didn't come up with a template that I could use.

The Validation Master List did confuse me though. Maybe it simply is a matrix of the equipment and relevant validation information. When I look at that observation now, that makes some sense. I just have to dig into the archives and get the info. What I didn't want to do was revalidate everything.
 

MIREGMGR

Inactive Registered Visitor
#6
What I didn't want to do was revalidate everything.
At least under current FDA and 13485/MDD guidelines, how do you classify a process as validated without an IQ/OQ/PQ? Grandfathering applies for products, but I wasn't aware that it conceptually applied to processes.

As for the IQ, OQ, and PQ procedures, wouldn't they be necessary or at least helpful for future machine validations, even if they don't necessarily apply to you at this time?
That's a key point. "Future machine validations" incorporates maintenance procedures. At least in my experience, physical elements of production processes--machines and measuring systems--inevitably need periodic re-calibration, component replacement, new or refurbished tooling, etc. All of those would require either annotation into the existing IQ/OQ/PQ per guidelines, or re-validation.

When a process is conducted on a contract basis with your firm retaining full regulatory responsibility, your control of those of their operations that affect the IQ/OQ/PQ currency, i.e. the validity of the validation, is a key part of your contract with them and of your ability to demonstrate to a regulator that you do in fact have process control.

We have the latter kind of relationship as a contract manufacturer with multiple customers, and we also have that kind of relationship as a product manufacturer with multiple non-medical-device subcontractors.
 

wrodnigg

Inactive Registered Visitor
#7
The Validation Master List did confuse me though. Maybe it simply is a matrix of the equipment and relevant validation information.
If I'd visit a company, that has "more than five" systems to validate, I would also suggest some overview document, that lists all systems that require validation, the current status (validated, in validation, project, retired...), date of last validation and the schedule for re-validation.
 
B

bonnieblue

#10
The Validation Master List did confuse me though. Maybe it simply is a matrix of the equipment and relevant validation information. When I look at that observation now, that makes some sense. I just have to dig into the archives and get the info. What I didn't want to do was revalidate everything.
it might also be referring to a validation master plan, as was suggested later, including the timeline for getting the machines validated and the deliverables expected from those validations.
please also consider that in order for machines to be considered validated on a continuing basis, there needs to be something that speaks to change control and when it's necessary to re-validate based on changes made to the machines.

good luck!
 

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