Hi everyone,

The compagny I'working for is designing, marketing and manufacturing medical devices for EU. We now want to market our products in US and we have to meet FDA requirements. We already have a VMP template, but it's a process validation oriented one. For the moment I don't have any "formal" document which summarize all the PV results as I used to know in automotive Intdustry (with the Design Validation Plan). Most of all, "design verification" and "design validation" sections of FDA 21CFR part 820 do not require such matrix. My questions are:

- Where do I have to address all the products V&V plan and results ? Am I totally free to define the procedure (such as to enter all the PV in the DHF without summary) ?

- My understanding of VMP is that this requirement has been defined for pharmaceutical fields, what about medical devices validations? Where can I find the requirements that VMP is the solution (I did not read such a thing in FDA 21CFR part 820). I guess it's in the GMP, but I can't find free booklet anywhere. And we speak about "design" or "development" (like APQP in automotive), not "Manufacturing"

- If the VMP is the solution, for exemple in two parts - one for the product and the other one for the process, which particular section and sentence of FDA 21CFR part 820 and GMP require that (I really have to convince my quality manager for the necessity of the SMQ evolution ...)?

Thanks for your help.

Stephane.

Hi Stephane,

I have moved your question to this forum to get more responses.

For info, we have lot of info on the VMP and Validation - did you do a SEARCH ?

Yes, I've made a search. I have found a lot of information about VMP and Process Validation. Fact is that I have found less information about Product validation. It sounds strange to me. I'm used to speak about the Design Validation Plan before the process validation. And it seems that GMP makes the VMP as a reference prior to DVP ...

Hi Steph
I have just joined this forum so am a bit rusty as to what is allowable and what is not.
Your VMP must give an overview of your company, What it is (facilities),what it does (products), who does it (personnel), Who is responsible for what (organogram), product flow (diagrams), personnel flow (diagrams), production processes, product flow, containment, and all other matters that contribute to producing your product.
This must be put together in a manner that demonstrates how you have integrated the requirement of 21 CFR Part 820 into all these activities.

In the VMP you only list your products and give a brief description that is sufficient for the regulator to understand their function and manufacturing processes.

If I can be of further assistance, please let me know.
Alex

What Alex says is sound advice. I run a similar approach to the VMP, but would eloborate a little further.

Different people will control the validations in slightly different formats, but this is mine.

The VMP is the top level document, the tracking schedule then details the index of the different validations - both process and product.

A further breakdown of the tracking schedule bullet points the key stages of the validations within DQ/IQ/OQ/PQ.

I could go on and on......but I won't.....

The protocols are mainly of a template nature, to provide some commonality across the paperwork. The VMP is your guide, and the individual protocols are tracked in the tracking schedule.

Hi Steph,

you may want to give this GHTF Validation Guidance a read and if you have any more questions just let us know.

http://www.ghtf.org/documents/sg3/sg3_fd_n99-10_edition2.pdf (http://www.ghtf.org/documents/sg3/sg3_fd_n99-10_edition2.pdf)

Ok, thank you all for your advises.

According to your opinion, what is the best, regarding FDA audit and/or evaluation : should I manage Design validation in a DVP dissociated of the VMP, or should I create a VMP in two section : Design Validation and Process Validation which summarizes all specifications and PV I could have made ?
And is there any else option ?

Ok, thank you all for your advises.

According to your opinion, what is the best, regarding FDA audit and/or evaluation : should I manage Design validation in a DVP dissociated of the VMP, or should I create a VMP in two section : Design Validation and Process Validation which summarizes all specifications and PV I could have made ?
And is there any else option ?

Your choice really based on what is best for your system, but if it was up to me I would probably keep design and process validation procedures separated as independent entities documentation-wise.

I would be very reluctant to use the above referenced document (Juan's document) . It would appear to be written in isolation with no regard to some of the fundamental issues that the regulations spell out. There is no attempt to key in the User Requirements Specification (URS) as the foundation stone of the validation chain of documentation. Then again there is no reference to executing a Design Qualification. So you are not qualifying your design before construction.

The Design Qualification (DS) is executed as the final verification that the Design Specification (DS) will deliver the requirements that the end user has detailed in the User Requirement Specifications (URS), and that the design is compliant with all applicable regulatory, company, health and safety requirements.

If you visualise the standard V validation chart where you descend the left leg of the V with the URS – FS – DS – (bottom of V) and ascend the right leg of the V, with IQ – OQ – PQ. Then your DQ fits in at the bottom of the V.

With new build equipment it must be authored and executed prior to build authority being given. With new build of facilities, it is extremely important since its execution verifies that the facility as proposed in the DS does what the end user wants, legally, safely and securely.
It cannot be over-emphasizes just how important the relationship between the URS and the DQ is. There are many horrendous blunders perpetuated by some really clever dedicated individuals, which would have been caught at DQ level, had there had been one.

What Is Validation.
We all have heard the diatribe about validation being ‘documented evidence etc’. Now more and more validation is being referred to;

Verification that the Users Requirements Specification, have been fully satisfied.
By implication, no URS renders an item impossible to validate. So validation consists of a stream (chain) of documents, all interrelated, none of which can stand alone.

Alex Kennedy
CEO
Validation Online

Thanks Alex !

I have found all the information I needed in a FDA guidance concerning Product validation.

I agree with you about V model. We must comply with this model because of the "User Needs" new requirements (ISO 60601-1-6, ISO 14971 ...). So we shall validate the product with a verified product, produced with the final manufacturing process and in actual (or simulated) use conditions ... This means that I have to verifify the product first and - this is my opinion - there is much more information about the way we have to validate a process than we can find to valildate a product ...
Thank you all for your info. I will use my old and well known automotive DVP (Design Validation Plan), in front of the VMP used for the process.

You may wish to note that this FDA document (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070336.pdf) is issued only by CDER, CBER, CVM and ORA. If your concern is medical devices i.e. CDRH, the applicable guidance is in fact the above-referenced GHTF document, in the creation of which CDRH played a key role. Tim Ulatowski, the CDRH Director of Enforcement, is a major proponent of GHTF efforts.

I would be very reluctant to use the above referenced document (Juan's document) . It would appear to be written in isolation with no regard to some of the fundamental issues that the regulations spell out.
The FDA's Center for Devices and Radiological Health (CDRH) has full involvement on the publication of the GHTF Process Validation Guidance, therefore it's in compliance of FDA regulations, read this: http://elsmar.com/Forums/showpost.php?p=299455&postcount=9

Then again there is no reference to executing a Design Qualification. So you are not qualifying your design before construction.

The Design Qualification (DS) is executed as the final verification that the Design Specification (DS) will deliver the requirements that the end user has detailed in the User Requirement Specifications (URS), and that the design is compliant with all applicable regulatory, company, health and safety requirements.
The link I referenced to is for the GHTF Process Validation Guidance, NOT design validation, this is pretty clear if you read the document's "scope" section.