Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello! 

I work as QA/RA for a small medical device company. We occasionally get requests from other companies, for whom we act as a supplier, to send our SOPs over email for their review. My question is: how do you handle these types of requests? Do you freely share your SOPs with outside companies (assuming you have some non-disclosure agreement) or do you guard these documents more closely? In the past, we have tended to view our SOPs as a form of IP since they involve some strategy, not to mention blood, sweat and tears!

All opinions welcome! Thank you!

What a timely post!  I'm having this exact conversation with one of our distributors. 

IMO, if we're talking about SOPs that govern how you carry out an element of the QSR, I am totally willing to share in the name of best practices and continuous improvement.  However, my distributor friends disagree and are unwilling to share based on the proprietary argument.

Honestly I can't imagine how much truly proprietary information could be incorporated into such procedures.  Let's take complaint handling - everyone's SOPs should describe when and how you receive complaint information and what you do with it, as per 21 CFR 820.198.    We're all following the same basic steps to meet the same requirements.  If there are pieces you don't want to share externally (staff names, etc.), then redact that stuff.  What's the big deal, right? 

With that being said, make sure to understand WHY they're asking for your SOPS.  Is it to see other ways of doing the same task, to review/approve what you're doing, or just to have a copy on file for their records?  I would make sure that roles, responsibilities, and boundaries are clearly established (via a Quality Agreement or some other mechanism)..

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Tina O'Brien RAC, MS
Director of Regulatory Affairs
Aroa Biosurgery
Auckland
New Zealand
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Original Message:
Sent: 30-Jan-2017 19:56
From: Anonymous Member
Subject: SOPs: Share freely or IP?

This message was posted by a user wishing to remain anonymous

Hello! 

I work as QA/RA for a small medical device company. We occasionally get requests from other companies, for whom we act as a supplier, to send our SOPs over email for their review. My question is: how do you handle these types of requests? Do you freely share your SOPs with outside companies (assuming you have some non-disclosure agreement) or do you guard these documents more closely? In the past, we have tended to view our SOPs as a form of IP since they involve some strategy, not to mention blood, sweat and tears!

All opinions welcome! Thank you!

Hi Anon.,
SOPs are generally considered proprietary. We would never share our SOPs and in fact, the pertinent SOPs to the operations of our business are in our drug master files. If you are supplying product to a customer, and they want input on your SOPs, who is actually deciding on what goes into them? How would you resolve conflicts? It is important that your procedures reflect the company's doing what you say, and saying what you do. 
That being said, we do have controlled documents that are available for sharing in PDF format - such as storage conditions, letters of guaranty, etc. For all those which are protocol-based, they do not leave our offices. However, we will allow on-site auditors to review while they are here.

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Holly Bilinski, MS, RAC
Ann Arbor, MI
United States
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Original Message:
Sent: 30-Jan-2017 19:56
From: Anonymous Member
Subject: SOPs: Share freely or IP?

This message was posted by a user wishing to remain anonymous

Hello! 

I work as QA/RA for a small medical device company. We occasionally get requests from other companies, for whom we act as a supplier, to send our SOPs over email for their review. My question is: how do you handle these types of requests? Do you freely share your SOPs with outside companies (assuming you have some non-disclosure agreement) or do you guard these documents more closely? In the past, we have tended to view our SOPs as a form of IP since they involve some strategy, not to mention blood, sweat and tears!

All opinions welcome! Thank you!

It has been a while since I worked in pharma so things may have changed in the last decade but at least in the medical devices arena sharing the Quality Manual (which in our case is aligned to clauses of ISO 13485) should provide adequate information to partners. I would be reluctant to share SOPs, not so much from an IP / proprietary viewpoint as from the potential for conflict arising from the sharing of SOPs which tend to be fairly detailed. 

To that extent I agree with Holly that SOPs are off the table, and interested parties are welcome to audit the operations, provided such an arrangement has been stipulated in the mutual agreement.  Agreements typically also include a requirement to inform the other party of any adverse finding, for instance following an FDA inspection.

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Homi Dalal RAC
Regulatory Affairs Leader
Dynamic Controls
Christchurch
New Zealand
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Original Message:
Sent: 01-Feb-2017 10:40
From: Holly Bilinski
Subject: SOPs: Share freely or IP?

Hi Anon.,
SOPs are generally considered proprietary. We would never share our SOPs and in fact, the pertinent SOPs to the operations of our business are in our drug master files. If you are supplying product to a customer, and they want input on your SOPs, who is actually deciding on what goes into them? How would you resolve conflicts? It is important that your procedures reflect the company's doing what you say, and saying what you do. 
That being said, we do have controlled documents that are available for sharing in PDF format - such as storage conditions, letters of guaranty, etc. For all those which are protocol-based, they do not leave our offices. However, we will allow on-site auditors to review while they are here.

------------------------------
Holly Bilinski, MS, RAC
Ann Arbor, MI
United States
------------------------------

Original Message:
Sent: 30-Jan-2017 19:56
From: Anonymous Member
Subject: SOPs: Share freely or IP?

This message was posted by a user wishing to remain anonymous

Hello! 

I work as QA/RA for a small medical device company. We occasionally get requests from other companies, for whom we act as a supplier, to send our SOPs over email for their review. My question is: how do you handle these types of requests? Do you freely share your SOPs with outside companies (assuming you have some non-disclosure agreement) or do you guard these documents more closely? In the past, we have tended to view our SOPs as a form of IP since they involve some strategy, not to mention blood, sweat and tears!

All opinions welcome! Thank you!

I work for a CMO, so we get these requests regularly. Our Quality System SOPs state that clients are welcome to view SOPs during an audit, but that we do not provide copies to them. We provide copies to regulatory agencies in support of client submissions. The process seems to be acceptable to our clients.

------------------------------
Charles Van Beveren
Manager, QA Regulatory Affairs
San Diego CA
United States
------------------------------

Original Message:
Sent: 30-Jan-2017 19:56
From: Anonymous Member
Subject: SOPs: Share freely or IP?

This message was posted by a user wishing to remain anonymous

Hello! 

I work as QA/RA for a small medical device company. We occasionally get requests from other companies, for whom we act as a supplier, to send our SOPs over email for their review. My question is: how do you handle these types of requests? Do you freely share your SOPs with outside companies (assuming you have some non-disclosure agreement) or do you guard these documents more closely? In the past, we have tended to view our SOPs as a form of IP since they involve some strategy, not to mention blood, sweat and tears!

All opinions welcome! Thank you!

I have been on both sides of this question as a supplier and as the OEM, and I think the approach Charles Van Beveren describes works best.

Keep in mind that FDA will require submission of contract manufacturer procedures for PMAs per their guidance Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff so if you are supplying US Class 3 devices your customer will need the procedures which document QSR compliance to submit to FDA.

There have also been times where it was better to provide a document than strictly adhere to a "no documents provided" policy. For example, if you can avoid an inspection by providing documents then I recommend you do that. But these can be handled on an exception basis, and communicating your policy early and having it documented is the best way to avoid awkward situations later.

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Ian Christianson
Marlborough MA
United States
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Original Message:
Sent: 01-Feb-2017 15:10
From: Charles Van Beveren
Subject: SOPs: Share freely or IP?

I work for a CMO, so we get these requests regularly. Our Quality System SOPs state that clients are welcome to view SOPs during an audit, but that we do not provide copies to them. We provide copies to regulatory agencies in support of client submissions. The process seems to be acceptable to our clients.

------------------------------
Charles Van Beveren
Manager, QA Regulatory Affairs
San Diego CA
United States
------------------------------

Original Message:
Sent: 30-Jan-2017 19:56
From: Anonymous Member
Subject: SOPs: Share freely or IP?

This message was posted by a user wishing to remain anonymous

Hello! 

I work as QA/RA for a small medical device company. We occasionally get requests from other companies, for whom we act as a supplier, to send our SOPs over email for their review. My question is: how do you handle these types of requests? Do you freely share your SOPs with outside companies (assuming you have some non-disclosure agreement) or do you guard these documents more closely? In the past, we have tended to view our SOPs as a form of IP since they involve some strategy, not to mention blood, sweat and tears!

All opinions welcome! Thank you!

I think one concern for suppliers of all kinds is that the customer will take your SOPs and turn around and give them to another supplier that is offering more competitive pricing, but has no SOPs.  The lower pricing and lack of SOPs are not unrelated.

There are lots of little companies out there that "could" supply the medical device industry cheaply, but they don't because they don't have (haven't invested in obtaining) the expertise needed to develop the appropriate processes, much less develop the SOPs needed to support those processes.  So you get the appropriate SOPs from a supplier that invested its resources to develop the processes and the SOPs, and then you give them to the cheap supplier and say, here, just follow these.

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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 30-Jan-2017 19:56
From: Anonymous Member
Subject: SOPs: Share freely or IP?

This message was posted by a user wishing to remain anonymous

Hello! 

I work as QA/RA for a small medical device company. We occasionally get requests from other companies, for whom we act as a supplier, to send our SOPs over email for their review. My question is: how do you handle these types of requests? Do you freely share your SOPs with outside companies (assuming you have some non-disclosure agreement) or do you guard these documents more closely? In the past, we have tended to view our SOPs as a form of IP since they involve some strategy, not to mention blood, sweat and tears!

All opinions welcome! Thank you!