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Publication of the new GMP+ C10 Acceptation requirements and procedure for Certification Bodies

środa, 15 lutego 2017

GMP+ International has worked together intensively with the Subcommittee Certification & Compliance to complete the new GMP+ C10 Acceptation requirements and procedure for Certification Bodies (hereafter GMP+ C10). Subsequently, the GMP+ C10 has been approved by the International Expert Committee and by the Dutch Accreditation Council. When publishing the new GMP+ C10, GMP+ International will withdraw immediately the GMP+ C1.

Below, we list the main changes:

  • Extension of the acceptation process period for new Certification Bodies from 13 weeks up to 26 weeks (article 3.1).
  • The GMP+ coordinator (or its deputy) must attend the harmonization meeting (article 3.3).
  • Clearer responsibilities for GMP+ coordinator (article 3.6).
  • Transfer the acceptance of certification body/auditor of another in the GMP+ accepted scheme from the GMP+ C1 to the GMP+ C10 (article 3.9).
  • Implementation of the GMP+ non accepted scopes, Country Notes and the Feed Responsibility modules (Annex 1).
  • Implementation of qualification requirements of inspectors, GMP+ coordinators and material experts (Annex 2).
  • An exemption for GMP+ MI102 and GMP+ MI103 if the GMP+ accepted auditors completed positively the RTRS endorsed auditor training (Annex 2)
  • Physical internal harmonization is mandatory with a minimum of once per 2 years (Annex 2).
  • The GMP+ coordinator is responsible for the internal harmonization and must participate (Annex 2).
  • A GMP+ coordinator must conduct/attend 7 audits per 12 months (Annex 2).
  • The GMP+ coordinator must be in possession of the lead assessor certificate (40 hours, IRCA or demonstrably equivalent certified) (Annex 2).
  • The table of competence criteria has been replaced by a reference to the relevant articles of the ISO17021 and ISO/TS22003, latest version (table C Annex 2).
  • The table of exemptions for an audit, examination and acceptation has been simplified (Annex 2).
  • The table of exemption to fulfill the GMP+ requirements that an auditor must conduct five audit per scope per year has been expended (Annex 2).
  • The duration of the validity of the Affreightment examination has been streamlined with the validity of the examination of Short Sea Shipping or Inland Waterway Transport (Annex 5).
  • Additional conditions for translation fees for examination (Annex 5).

 

Attention:

GMP+ International wants to point out several deviations related to the requirements of the new GMP+ C10. This deviations were published by the means of an executive degree as stated in article 11 of the GMP+ A1 General Regulations and are applicable. These deviations are:

  • GMP+ Feed Responsibility Assurance auditor training 
  • Acceptation of GMP+ auditors/inspectors 

The changes as follow up of these executive degrees will be integrated in the next version of the GMP+ C10.