Guidance for GMP+ FSA certification related to “toll manufacturers”.

30 November 2015

Participants may decide to outsource their production activities to so called “toll manufacturers”. Until now these participants have been certified either with a Production scope, or just with the scope Trade, which is not in compliance with GMP+ FSA certification requirements.

On request of our International Expert Committee several subcommittees are working on a solution to improve the GMP+ FSA scope system by adding an additional scope, “private labelling” into the GMP+ FC scheme. GMP+ International expects to introduce this solution on short notice.

Until that time GMP+ International expects that participants will be certified in accordance with the requirements of the GMP+ FC scheme and therefore we bring this guidance under your attention.

  • New participants outsourcing their production activities must be certified for a Production scope.
  • Participants outsourcing their production activities currently under the certification scope for Trade do not have to be re-certified for a Production scope at this moment. After the implementation of the new scope “private labelling”, they must - beside the scope Trade - also become certified for the scope private labelling.

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