Validation as of Vendor Side

[nuraz]

Hi All,

Has anyone here worked as a vendor for a machine maker for medical device or pharma industries?

We provide automated machine designs based on approved customer concepts for the medical devices or pharmaceutical industries. Our company is ISO 13485 certified.

For eg: Catheter assembly and inspection machine, vial inspection machine, packaging machine and etc.

Currently, we proceed with the design validation (DQ) for the machine. Additionally, we will cover IQ, OQ, and PQ, which mainly focus on machine and software validation, as our machines are designed to meet GAMP 5 Category 5 and 21 CFR Part 11 requirements. We follow the V-model methodology which is required to have URS(from customer), FRS,SRS,VRS,HRS, DS, Source Code, Configurable Parameter, Recipe and IQ,OQ,PQ.

We will perform internal verification and validation before sending the machines to our customers, which perform during FAT and SAT. From my understanding, as a vendor, we will share the executed validation documents for the FAT and SAT upon customer request so they can include / attach them as a part of their full process validation .

However, we are currently confused because some customers expect the vendor to provide the entire IQ, OQ, and PQ documentation for their process validation which is need to match with all the requirements for their internal site which is beyond our expertise. From what I understand, process validation actually falls under the customer’s responsibility, please correct me if I'm wrong. Fyi, at this moment we are not covering validation services beyond the machine design itself.

Need your expertise to advise on this. Thank you.

 

[yodon]

I read this and think "opportunity" for you! Yes, the customer has ultimate responsibility but no reason the effort can't be outsourced (to you at a nice cost). You would need to have suitable processes defined, but if you're having multiple customers ask, seems like something worth pursuing.

 

[nuraz]

I read this and think "opportunity" for you! Yes, the customer has ultimate responsibility but no reason the effort can't be outsourced (to you at a nice cost). You would need to have suitable processes defined, but if you're having multiple customers ask, seems like something worth pursuing.

Yes, I agree. However, we are still unclear about how to proceed.

How many headcounts will be required for this service, and what specific skills, experience, and training are necessary? Some process validation at the customer site may take more than a year, and since the vendor is not working with their organization, could this limitation impact the timeline on the customer side? This service seems to require close collaboration between the vendor and the customer, as both parties will need to outline roles and responsibilities in an agreement to ensure smooth operations.

Currently, we also do not have sufficient headcount for internal execution of the machine and software validation due to the overlapping timelines of multiple projects for the different customers

 

[yodon]

You could always bring on contractors to do the work until things settle out and you understand what your hiring needs might be (if any). Shouldn't be hard to find contractors with process validation experience. Make sure they have solid statistical skills.

Some process validation at the customer site may take more than a year

I don't understand this. Process validations I've been involved with take far less than that. IQ and OQ maybe a few weeks and then PQ maybe a few more weeks. Throw in a couple of weeks on both sides for prep, management, and reporting and

This service seems to require close collaboration between the vendor and the customer, as both parties will need to outline roles and responsibilities in an agreement to ensure smooth operations.

Exactly!

Currently, we also do not have sufficient headcount for internal execution of the machine and software validation due to the overlapping timelines of multiple projects for the different customers

Contractors can be expensive and you may not realize much profit in the short run, but it sure sounds like a way to expand your offerings and better server your customers.

 

[nuraz]

You could always bring on contractors to do the work until things settle out and you understand what your hiring needs might be (if any). Shouldn't be hard to find contractors with process validation experience. Make sure they have solid statistical skills.

Thank you so much. I will propose on this to the management.

I don't understand this. Process validations I've been involved with take far less than that. IQ and OQ maybe a few weeks and then PQ maybe a few more weeks. Throw in a couple of weeks on both sides for prep, management, and reporting and

I have also experienced working for a medical device manufacturer as the process engineer. Typically, the completion of process validation depends on the criticality of the processes themselves, testing for any impact on the existing product, and updating related documents such as PFMEA, SOPs, sterility assessments, biocompatibility assessments and etc. However, if the transition is mainly from a manual to a fully automated process, the validation should be completed within 5-6 months or even less.

But then in my current role as a vendor, our engineering team has encountered situations where the customer's IQ, OQ, and PQ processes can take 1.5 to 2 years. The customer handles the process validation themselves and mainly seeks support from the vendor for machine improvements to align with their specific internal requirements upon request.

I am not sure what exactly lead to this extended timeline at customer side, maybe due to the material issue or something.