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What level of control should be exercised on distributors?
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What level of control should be exercised on distributors?
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distributors (general), distributors (medical devices), supplier control and monitoring
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  Post Number #1  
Old 1st November 2016, 08:50 PM
Mark Meer

 
 
Total Posts: 859
Question What level of control should be exercised on distributors?

Question for discussion: What level of control/requirements do you exercise on distributors?

Do you treat them as suppliers (providing distribution service) or customers (they issue an order, you fill it, no additional control necessary).

If the former, what qualification requirements do you impose? For example, do you:
  • Require that they maintain distribution records though simple supplier agreement?
  • Ensure they maintain distribution records by periodically auditing their records to ensure that sufficient information is being maintained in case recall is necessary?

Just curious what are the typical agreements/requirements between manufacturers and distributors (e.g. for medical devices).

MM

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  Post Number #2  
Old 7th November 2016, 08:36 PM
Access2hc's Avatar
Access2hc

 
 
Total Posts: 40
Re: What level of control should be exercised on distributors?

sometimes both as a supplier and as a customer. first of all gain clarity over the ownership of the stock - (from finance, supply chain, commercial) to understand when products are shipped, who owns the stock when it clears customs and reaches the warehouse. of course when the product is shipped to the end customer, that's customer property...

but as a supplier, the distributor must fulfill all of it's quality and regulatory obligations (QMS, traceability, document control, post market activities in collaboration with the manufacturer). all to be embedded in the written agreement with them. Now this written agreement is a requirement in the 2016 version of ISO13485

Cheers,
Ee Bin
Access2hc
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  Post Number #3  
Old 7th November 2016, 10:04 PM
Mark Meer

 
 
Total Posts: 859
Re: What level of control should be exercised on distributors?

Thanks Access2hc!

Curious: how are such agreements typically worded?
I realize it varies depending on the relationship, but in general, is it sufficient to just have a line item such as:

"(distributor) agrees to maintain distribution records, and fulfill any applicable regional record keeping and post-market regulations."

...or does the level of scrutiny have to be much more specific: e.g. specifying exactly what information is to be maintained, and allowing for the manufacturer to perform quality audits as necessary?
  Post Number #4  
Old 8th November 2016, 04:31 AM
Access2hc's Avatar
Access2hc

 
 
Total Posts: 40
Re: What level of control should be exercised on distributors?

Hi Mark - the latter is preferable as it needs to be specific and especially if you're a US/EU based manufacturer, and that the distributor is in a regulated country.

you may receive some push back from the legal/purchasing department that owns the Agreement and either have you come up with a separate Quality Agreement, or be asked to keep the details to the 'bare essentials'. But it is indeed a long term benefit for specificity in this area.

hope it helps.

Cheers,
Ee Bin
Access2hc
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  Post Number #5  
Old 8th November 2016, 10:50 AM
pkost

 
 
Total Posts: 824
Re: What level of control should be exercised on distributors?

The control of distributors should be risk based. What do you need/require from them, what is the consequence of their failure to comply? A class I product should be treated differently from Class III implantables, similarly traditional products vs innovative

Things to consider:
1. Storage requirements/compliance
2. vigilance and complaint handling and other post marketing surveillance activities
3. Batch control and traceability
4. Information and document control - do they "sell" your product, do they produce marketing literature...how do you control the claims they make

In addition to the regulatory considerations, your business may want to consider the brand/commercial aspects. If they are distributing your brand, they are a face of your product, the service they offer their customers will impact your brand, you may want to monitor and control this


As mentioned, there are various ways to provide assurance, everything should be documented in an agreement that clearly indicates obligations and responsibilities, along with methods of control/oversight and consequences of breach

Within the agreement you may want to
1. enable site audit (planned and unannounced)
2. Enforce the distributor maintains certification...ISO/GDP
4. Include control points (written into the contracts) e.g. you sign off and approve all marketing materials relating to your product, you train and control the sales force etc.
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  Post Number #6  
Old 8th November 2016, 03:35 PM
Mark Meer

 
 
Total Posts: 859
Re: What level of control should be exercised on distributors?

Quote:
In Reply to Parent Post by Access2hc View Post

...but as a supplier, the distributor must fulfill all of it's quality and regulatory obligations (QMS, traceability, document control, post market activities in collaboration with the manufacturer). all to be embedded in the written agreement with them. Now this written agreement is a requirement in the 2016 version of ISO13485
This is only the case for implantable medical devices though, no?

7.5.9.2. requires that "...suppliers of distribution services or distributors maintain records of the distribution of medical devices to allow traceability and that these records are available for inspection." but this is a particular requirement that applies only to implantable devices.
Thanks to Mark Meer for your informative Post and/or Attachment!
  Post Number #7  
Old 8th November 2016, 04:16 PM
BoardGuy

 
 
Total Posts: 186
Re: What level of control should be exercised on distributors?

Quote:
In Reply to Parent Post by Mark Meer View Post

7.5.9.2. requires that "...suppliers of distribution services or distributors maintain records of the distribution of medical devices to allow traceability and that these records are available for inspection." but this is a particular requirement that applies only to implantable devices.
I would take a step back and look at 7.5.9.1 because you need to look at the applicable regulatory requirements for the product produced in addition to just the requirements of 13485.
Thanks to BoardGuy for your informative Post and/or Attachment!
  Post Number #8  
Old 27th July 2017, 02:51 PM
YellowQCPro

 
 
Total Posts: 10
Re: What level of control should be exercised on distributors?

Don't forget to include record retention requirements!
Thanks to YellowQCPro for your informative Post and/or Attachment!
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