Regulatory Open Forum

Hi All,

I see in MDSAP (Chapter 1 Section 5) that Canadian distributors need to be qualified as suppliers and controlled, as appropriate.

It is not as clear if distributors in Australia, Japan, and Brazil also need to be qualified as suppliers.

Does anyone have any experience with an MDSAP audit where this was required?  Any other comments would also be appreciated.

Thanks,

Craig

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Craig Jolicoeur
RA/QA Manager
San Marcos CA
United States
------------------------------

Hi Craig - yes, we went through the MDSAP audit last summer and all distributors should be classified as critical suppliers and managed through that process.  I created a separate process and called it critical suppliers: distributors.  I did this because I wanted to differentiate between critical suppliers which supply product components and distributors.  This passed the audit and worked for us.  The big thing was in that file we needed to have quality agreements for each and make sure your quality agreements have the appropriate reporting requirements for that country.

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Emilia Gonzalez
Lyndhurst OH
United States
------------------------------

Original Message:
Sent: 26-Apr-2019 09:20
From: Craig Jolicoeur
Subject: MDSAP - Distributors on ASL

Hi All,

I see in MDSAP (Chapter 1 Section 5) that Canadian distributors need to be qualified as suppliers and controlled, as appropriate.

It is not as clear if distributors in Australia, Japan, and Brazil also need to be qualified as suppliers.

Does anyone have any experience with an MDSAP audit where this was required?  Any other comments would also be appreciated.

Thanks,

Craig

------------------------------
Craig Jolicoeur
RA/QA Manager
San Marcos CA
United States
------------------------------

Craig,

Definitely as Emilia mentioned, all distributors should be controlled in each of the countries (for MDSAP and would argue others as well - like European Union now under the MDR).  I have posted on other threads about creating a distributor management process similar or mirror of a supplier management process.  If you only have 1 or 2 distributors maybe can handle in your supplier management program, but definitely more should be a separate process.  This should also be risk based because while many think distributors should be "critical" suppliers, all distributors may not be the same either.  Some distributors may merely get the product, put on a shelf, and then fulfil orders so they need controls like order processing.  Other distributors may take complaints for you and pass them along.  Other distributors may perform servicing and conduct technical support.  And yet other distributors may do re-packaging and re-labeling.  Clearly define yours and their role in the product distribution process - not only through agreements either.  Some people like to just say, 'Its in the agreement.' but there is usually much more than that needs to be controlled in the quality system.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 26-Apr-2019 11:51
From: Emilia Gonzalez
Subject: MDSAP - Distributors on ASL

Hi Craig - yes, we went through the MDSAP audit last summer and all distributors should be classified as critical suppliers and managed through that process.  I created a separate process and called it critical suppliers: distributors.  I did this because I wanted to differentiate between critical suppliers which supply product components and distributors.  This passed the audit and worked for us.  The big thing was in that file we needed to have quality agreements for each and make sure your quality agreements have the appropriate reporting requirements for that country.

------------------------------
Emilia Gonzalez
Lyndhurst OH
United States

Original Message:
Sent: 26-Apr-2019 09:20
From: Craig Jolicoeur
Subject: MDSAP - Distributors on ASL

Hi All,

I see in MDSAP (Chapter 1 Section 5) that Canadian distributors need to be qualified as suppliers and controlled, as appropriate.

It is not as clear if distributors in Australia, Japan, and Brazil also need to be qualified as suppliers.

Does anyone have any experience with an MDSAP audit where this was required?  Any other comments would also be appreciated.

Thanks,

Craig

------------------------------
Craig Jolicoeur
RA/QA Manager
San Marcos CA
United States
------------------------------

Hi Craig - for sure they do.  As do other critical suppliers such as regulatory advisers or authorised representatives.

We act for overseas manufacturers as Sponsor (Australian for authorised representative) here in Australia and therefore are responsible for compliance to Australian law and communications with TGA and other regulatory agencies on behalf of the international manufacturer.  We regularly get queries about this from clients undergoing MDSAP.  

Two things are usually necessary:

1. Evidence of vendor accreditation (documented client review of our ISO certification, CVs of responsible leadership and copies of key processes)
2. Copy of service contract which sets out specific regulatory responsibilities of both parties.

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Founder and Principal Consultant
Brandwood Biomedical
Sydney, Australia
Arthur@brandwoodbiomedical.com
------------------------------

Original Message:
Sent: 26-Apr-2019 09:20
From: Craig Jolicoeur
Subject: MDSAP - Distributors on ASL

Hi All,

I see in MDSAP (Chapter 1 Section 5) that Canadian distributors need to be qualified as suppliers and controlled, as appropriate.

It is not as clear if distributors in Australia, Japan, and Brazil also need to be qualified as suppliers.

Does anyone have any experience with an MDSAP audit where this was required?  Any other comments would also be appreciated.

Thanks,

Craig

------------------------------
Craig Jolicoeur
RA/QA Manager
San Marcos CA
United States
------------------------------

Thank you all for your guidance
Craig

------------------------------
Craig Jolicoeur
RA/QA Manager
San Marcos CA
United States
------------------------------

Original Message:
Sent: 28-Apr-2019 08:17
From: Arthur Brandwood
Subject: MDSAP - Distributors on ASL

Hi Craig - for sure they do.  As do other critical suppliers such as regulatory advisers or authorised representatives.

We act for overseas manufacturers as Sponsor (Australian for authorised representative) here in Australia and therefore are responsible for compliance to Australian law and communications with TGA and other regulatory agencies on behalf of the international manufacturer.  We regularly get queries about this from clients undergoing MDSAP.

Two things are usually necessary:

1. Evidence of vendor accreditation (documented client review of our ISO certification, CVs of responsible leadership and copies of key processes)
2. Copy of service contract which sets out specific regulatory responsibilities of both parties.

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Founder and Principal Consultant
Brandwood Biomedical
Sydney, Australia
Arthur@brandwoodbiomedical.com

Original Message:
Sent: 26-Apr-2019 09:20
From: Craig Jolicoeur
Subject: MDSAP - Distributors on ASL

Hi All,

I see in MDSAP (Chapter 1 Section 5) that Canadian distributors need to be qualified as suppliers and controlled, as appropriate.

It is not as clear if distributors in Australia, Japan, and Brazil also need to be qualified as suppliers.

Does anyone have any experience with an MDSAP audit where this was required?  Any other comments would also be appreciated.

Thanks,

Craig

------------------------------
Craig Jolicoeur
RA/QA Manager
San Marcos CA
United States
------------------------------