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Guidance for the assessment of strict and complete physical and organizational separation of the production of GMP+ feed, non GMP+ feed, food and nonfeed/nonfood

donderdag 30 maart 2017

It was pointed out to GMP+ International that the requirements referring to the produc-tion of GMP+ feed must be strict and complete physical and organizational separated from the production of non GMP+ feed, food and nonfeed/nonfood products is clearly defined. The GMP+ A1 General Regulations has for example another interpretation than the GMP+ B1/B2 documents. This is an undesirable situation which has to be solved as soon as possible.

At this moment GMP+ International is working on the re-design of the GMP+ Feed Certification scheme. This is an intensive project which cannot be finalized this year. The streamlining of the requirements mentioned above will be part of the re-design. GMP+ International decided not to wait on the finalization of the re-design and developed a temporary solution. As from the publication of this guidance GMP+ International tolerates the following scenario’s:

  1. It is allowed to produce GMP+ feed and non GMP+ feed within the same business location and/or on the same production line. In case GMP+ feed is produced in the same production line of the non GMP+ feed, the non GMP+ feed has to comply with GMP+ requirements.
  2. It is allowed to produce GMP+ feed and food within the same business location and/or on the same production line. In case GMP+ feed is produced in the same production line of the food, the food has to comply with GMP+ requirements. This is not applicable when the GMP+ feed is a sub product of the main food production line. Then the food product doesn’t need to comply with the GMP+ requirements.
  3. It is allowed to produce GMP+ feed and non-feed/non-food within the same business location but not on the same production line.
  4. It is not allowed to produce GMP+ feed and non-feed/non-food/biomass on the same (part of the) production line.

In scenario’s 1 till 3, the risk of cross contamination must be secured in the HACCP-plan, making clear reference to proper control measures of this risk and all legal requirements must be secured.

Follow up:

This new interpretation will be tolerated by GMP+ International until there is a final solution secured in the relevant normative document(s).INDEX