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Guidance for the assessment of strict and complete physical and organizational separation of the production of GMP+ feed and other (non-feed) products

czwartek, 13 kwietnia 2017

There appears to be some discussion about how to interpret the GMP+ clause which requires a strict and complete physical separation in the factory. This memo is meant to give some clarity.

Strict and complete physical and organizational separation

Some considerations about the above mentioned requirement to create separation  between GMP+ feed products and products that can give unwanted contamination (nonfeed/nonfood):

  • In different standards different wording is used. This is inconsistent and gives confusion. This requirement about separation is part of the requirements about Infrastructure
  • In all the standards this requirement is meant to assure separation between GMP+ feed and nonfeed/nonfood in order to avoid unintentional contamination of the feed with probably harmful substances. Examples of the latter range of products are given: fertilizers, fuels, cleaning and disinfectant agents, glass, crop protection agents, waste.
  • Within the GMP+ scheme it is not forbidden that these products are in the same location and that the same equipment is used for processing these products.
  • These requirements are in discussion, and will be changed.

In anticipation of this change the current requirements regarding strict and complete physical and organization separation between GMP+ feed and non-feed should be interpreted like this;

  • There must be such a separation between GMP+ feed products and nonfeed/nonfood products that the safety of the GMP+ feed products is not negatively affected.
  • Control measures must be in place to assure this separation at all stages of processing, producing, (internal) transportation and storage. Physical separation and organizational separation are examples of such control measures.
  • These control measures must be the results of a HACCP risk analysis and must be monitored.

 

Exclusion of feed products from scope of certification

Related to the topic above, it is also good to focus on what is laid down in article 4 of GMP+ A1

In this article is stated that all feed production must be covered under the scope of the certification. It is not possible to exclude parts of the feed production. 
The background for this strict requirement is mainly to give (1) transparency: all feed coming from a certified production location is GMP+. A customer/livestock farmer does not have to worry. He can trust the feed which is delivered to him, is produced under a certified feed safety control system. Also, (2) this requirement should make life for auditors more easy when auditing this location

There is discussion about this requirement. It was laid down a long time ago and at this moment there are other requirements that assure transparency. Think of the positive declaration.

However, members of expert committees still have doubts. Results of discussion here is awaited this year. For the moment, the current rule in GMP+ A1 applies.