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Transport affreightment of own products

How Certification Bodies can obtain GMP+ auditors for Transport & Affreightment of own products outside Europe. GMP+ certified companies outside of Europe are transporting GMP+ certified products to own locations and to third parties. At this moment transport of GMP+ products by their own vehicles and barges must be GMP+ certified under the standard GMP+ B4 or GMP+ B4.3. The same applies for affreightment activities.

In some regions there are no accepted auditors/inspectors available. Therefore currently and in the previous year’s GMP+ International issues exemptions to GMP+ certified companies related to Transport & Affreightment outside Europe for the following scopes of GMP+ B4 or GMP+B4.3:

1. Transport of feed, Road transport
2. Transport of feed, Inland waterway transport
3. Affreightment of Inland waterway transport
4. Affreightment of Sea transport
5. Affreightment of Short sea shipping
6. Affreightment of Rail transport

Traders and producers can gatekeeper road transport and inland waterways when they outsource this activity to other transport companies.
Transport of feed, Rail transport and Affreightment of Road transport can be brought under certification on voluntary basis by participants but if the company chooses to do so the acceptance of the auditors gives the same difficulties.

The acceptance requirements for auditors/inspectors outside Europe will be adapted in the GMP+ FC scheme as from the publication date of this letter by an Executive decree article 11.1 GMP+ A1 General Regulation valid until  December 31st,2023.

Because the GMP+ FC scheme is a worldwide scheme it is an undesirable situation to apply the GMP+ rules in a different way in and outside Europe. And therefore,  as of t January 1st,2021 no  Exemptions will be granted for certification of Transport & Affreightment activities outside Europe. Certification Bodies and GMP+ certified companies need to prepare for this situation.

Explanation

Companies that must be certified:

A) A company that is transporting (via road transport / inland waterway vessel) feed as a service to third parties.
B) A producer / trader who is transporting (via road- / inland waterway transport) own products to third parties (packed and unpacked products).
C) A producer / trader who gives the order for transport by train (rail) or (short) sea / inland waterway going vessel.

Examples of companies that do not need to be certified (so called internal transport, see definition GMP+ A2):

A) Transport within company’s premises
B) Transport between different locations of the same company

Note: Delivery to a third party is considered as external transport.

Facts

  • Exemptions as mentioned under A – C explanation can be requested until September 30th, 2020.
  • Issued exemptions for the certification of Transport & Affreightment outside Europe are valid until January 1st, 2021, however, this transport must be guaranteed by the company in accordance with the GMP+ B4 requirements. It does not have to be certified and provided with a separate scope.
  • GMP+ accepted certification bodies need to prepare and train the GMP+ auditors.
  • For Compliance audits, deviations related to the activities of this memo will be included as a point of attention in the audit report but won’t be reported as a nonconformity. From January 1st, 2021 the GMP+ International auditors are obliged to raise a nonconformity if companies or outsourced services are not certified for the scopes mentioned above.
  • For the acceptance of local GMP+ auditors for the scopes of this memo, adapted requirements will be applicable until  December 31st, 2023.

Adapted temporary requirements acceptance auditors / inspectors

Adapted acceptance requirements for local GMP+ accepted auditors / inspectors outside EUROPE for the relevant scope(s) of this memo until 31.12.2022 (except *)31.12.2023) will be as follows:

Current requirement

Temporary requirement

Additional requirement

Succeed for the relevant GMP+ examination.

 

 

Minimum of 3 audits/inspections as an observer specifically for the relevant GMP+ scope(s) of this memo.

One witness audit by a GMP+ auditor / inspector accepted for the relevant scope

 

*) Number of 5 audits per scope per year to keep the GMP+ acceptance.



For the number of audits / inspections per year to keep the acceptance for the relevant scope(s) of this memo a number of 3 audits / inspections per year will be sufficient for the period of 01.01.2021 until 31.12.2023.

 

Each GMP+ auditor, technical/material expert, technical reviewer, inspector must have demonstrably followed an established initial training program. The content of the training program must be demonstrable focused on the scope.

 

Initial training of 8 hours for the scope transport.
Initial training of 4 hours for the scope affreightment.

Training must be performed under the responsibility of the involved GMP+ coordinator. This does not have to be a physical training but can be done by skype or other means of communication by the coordinator.

Experience in the assessment of audit reports (minimum 3 for the relevant scope) or conduct/attend a minimum of 10 audits for the relevant scope.
Experience in the assessment of GMP+ B4.3 checklist (minimum 3 in total per calendar year) or conduct/attend a minimum of 10 inspection

GMP+ auditors / inspectors accepted by means of the witness audit can review audit reports for the relevant scope(s) of this memo after performing 3 audits / inspections after acceptance of the relevant scope.

 

 

Adapted acceptance requirements for CB’s without acceptance/accepted auditors / inspectors for the relevant scope(s) of this memo until 31.12.2022 (except *)31.12.2023) will be as follows:

Current requirement

Temporary requirement

Additional requirement

Succeed for the relevant GMP+ examination.

 

 

New auditors / inspectors have to comply with the education; knowledge; audit skills and work experience requirements of Annex 2 of the GMP+ C10.

 

 

A minimum of 5 independently carried out audits / inspections as lead auditor / inspector in relevant fields of work as laid down in GMP+ BA10 Minimum requirements for Purchasing or schemes as mentioned in Annex 2 of the GMP+ C6/C12.

A minimum of 5 independently carried out audits / inspections as lead auditor / inspector in relevant fields of work as laid down in GMP+ BA10 Minimum requirements for Purchasing or schemes as mentioned in Annex 2 of the GMP+ C6/C12.

 

Minimum of 3 audits/inspections as an observer specifically for the relevant GMP+ scope(s) of this memo.

One witness audit by a GMP+ international auditor for the first audit. Costs for these audits / inspections will be charged by GMP+ International to the CB.

 

*) Number of 5 audits per scope per year to keep the GMP+ acceptance.






For the number of audits / inspections per year to keep the acceptance for the relevant scope(s) of this memo a number of 3 audits / inspections per year will be sufficient for the period of 01.01.2021 until 31.12.2023.

 

Each GMP+ auditor, technical/material expert, technical reviewer, inspector must have demonstrably followed an established initial training program. The content of the training program must be demonstrable focused on the scope.

 

Initial training of 8 hours for the scope transport.
Initial training of 4 hours for the scope affreightment.

Training must be performed under the responsibility of the involved GMP+ coordinator. This does not has to be a physical training but can be done by skype or other means of communication by the coordinator.

Experience in the assessment of audit reports (minimum 3 for the relevant scope) or conduct/attend a minimum of 10 audits for the relevant scope.
Experience in the assessment of GMP+ B4.3 checklist (minimum 3 in total per calendar year) or conduct/attend a minimum of 10 inspection

GMP+ auditors / inspectors accepted by means of the witness audit can review audit reports for the relevant scope(s) of this memo after performing 3 audits / inspections after acceptance of the relevant scope.


 

 

 

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