Sourcing a Sterile Product - Asking for supplier for too much regulatory stuff?

[jwgideon123]

I am a QA/RA director for a start up company - initial importer and distributor - whose owners and stakeholders have been in the initial importing / distribution business a long time.

My background is working for actual med device manufacturers.

I am the only QA/RA entity in this organization and as we source med devices to distribute - I ask for things that I would expect the supplier to have, given that they also supply to the other larger distributors in the US.

One particular example I am struggling with:
We are starting to source sterile product. I have explained that I would prefer to have an expiration date on sterile product but the supplier must show me accurate stability data to support that shelf life. I am getting a lot of push back - "No one has ever asked for that before, you are asking for too much detail." etc etc.

As an initial importer - I am treating the suppliers as an extension of the company I work for as we take responsibility for the product once it has our name on it and we distribute. I struggle with making sure these suppliers have adequate data - isn't it my responsibility to make sure the supplier has done their due diligence or am I truly being overbearing?

I am finding this difficult because being the only QA resource in the company - I have no one to bounce this off of...

Help anyone?!

 

[MIREGMGR]

Re: Asking for too much regulatory stuff?

This forum section pertains to US FDA so I assume you are located, and distribute, in USA.

As such, the products you distribute must conform to US FDA requirements, including for manufacturing and labeling. Most sterile products are US FDA Class II or above, indicating that a responsible party holds a 510(k) or other regulatory clearance, and has shown conformance to FDA requirements to obtain that clearance.

In the case of your particular example...sterilization expiration...it is common for sterile-device packaging to state an expiration date based on packaging validation studies; this is regarded as normal by the marketplace, at least for professional use devices; and certainly the relevant FDA Recognized Consensus standards expect expiration dating and provide means for those validation studies. But, (quoting from http://www.fda.gov/MedicalDevices/D...temRegulationLabelingRequirements/default.htm):

Shelf-life dating solely for package integrity and sterility is not usually required by FDA for general medical devices.

Of course, as noted many sterile products have a 510(k), and a need for such labeling may have been created as a part of that 510(k) process. And, devices headed to Europe, per MDD Annex I Section 13.3(e) are generally regarded as requiring an expiration date based on validation studies, per the mentioned international standards.

More generally addressing your overall message: I think your approach is entirely reasonable if your employer is committed to quality. If I were in your place, I'd be highly doubtful about a sterile-device supplier that, in response to questions about packaging stability, said I was asking for too much information. The clear inference, I'd think, is that they don't know because they haven't studied or tested...so the products may or may not be reliably packaged so that they stay sterile.

 

[jwgideon123]

Just posted in another thread and realized I posted this - so just now reading your response!

Thank you!

Because my background is from the actual manufacturers of the device, it is hard for me to calibrate myself of what I should be checking and evaluating from a distributor's perspective with our name on the label. I feel sometimes I may be asking for details that others wouldn't, but it is our name on the product and I have the end users in mind.