Public Consultation: Proposed changes GMP+ FC scheme

Tuesday, March 20, 2018

GMP+ International published proposed changes to the GMP+ FSA module on the website.

Most changes are meant to link the new GMP+ B11 Protocol for GMP+ registration for laboratories and GMP+ BA7 Specific requirements for by-products from Oil and Fat Industry to the relevant B and BA documents. Changes with regard to transport are mainly intended to streamline the requirements within the GMP+ FSA module.

 

GMP+ International would like to hear your opinion 

In accordance with the procedure for adjustments to the GMP+ FSA module, all proposed changes will be published on the website for public consultation.

The changes concern following GMP+ standards:

 

  • Proposal for amendment to A2
  • Proposal for amendment to B1
  • Proposal for amendment to B1.2
  • Proposal for amendment to B2
  • Proposal for amendment to B3
  • Proposal for amendment to B4
  • Proposal for amendment to B4.3
  • Proposal for amendment to BA4
  • Proposal for amendment to BA10
  • Proposal for amendment to BA10, Annex 9
  • Proposal for amendment to BCN-NL2
  • Proposal for amendment to release procedure 

 

Reaction form 

All GMP+ participants are invited to review the proposed changes and to respond to them via this reaction form. In addition, all GMP+ participants are asked to ask the laboratories carrying out analyses for them to respond to the proposed changes. 

You can respond until March 28h 2018. After this date, the comments will be implemented in final drafts that will then be submitted to the International Export Committee for approval.