Publication GMP+ normative documents
08 September 2016
GMP+ International has worked together intensively with the Subcommittee Certification & Compliance to complete new normative documents for the use of GMP+ Logos and Certification requirements. Subsequently, the relevant normative documents have been approved by the International Expert Committee and by the Dutch Accreditation Council (Raad voor Accreditatie RvA) (only GMP+ A3 and C11). As a result of this, GMP+ International publishes the following new normative documents. Below, we will list the main changes in outlines.
GMP+ A3 GMP+ Logos/Trademarks.
- Because GMP+ International remains the owner of the GMP+ Logos/Trademarks at all times, GMP+ International grants the users the exclusive right to use the GMP+ Logos/Trademarks. The GMP+ requirements regarding the traceability of the GMP+ Logo by means of adding the letters FSMS and the unique registration number of the user, are hereby lapsed (chapter 3)
- Clarity (including guidelines) for the use of the GMP+ Logos/Trademarks (article 3.1).
- Abuse of GMP+ Logos/Trademarks (chapter 4).
Attention: the GMP+ A3 document is a temporary document valid for the transition period for the change of the GMP+ FC scheme FSA module from ISO/IEC 17065 to ISO/IEC 17021 and ISO/TS 22003. This period will end approximately 4th quarter 2020. In case this period is extended we will inform you.
GMP+ C3/C6 Assessment and certification criteria for GMP+ certification – product/process certification.
The following changes have been implemented:
- Expansion of the possibilities to intermediately expand the scopes of GMP+ participants outside of the regular audits (article 2.2)
- The requirements of the unannounced audits are assured, including the minimum required audit times (article 2.4 and Annex 2).
- The requirements of the repeat audit have been adjusted (article 2.7)
- The requirement of the audit rotation for carrying out GMP+ audits has been adjusted (article 2.8)
- A new GMP+ certificate template (combined with temporary acceptance) (article 2.10)
- Clear and more transparent assessment criteria and measures for Feed Safety Assurance (Annex 1) and Feed Responsibility Assurance (only Annex 1 of GMP+ C6). The critical nonconformities have been adjusted regarding to the required EWS notification; stricter supervision and suspension are now possible.
- Expansion of requirements to qualify for audit time reduction (Annex 2)
- New audit times for assessing Gatekeeper files (Annex 2)
- Adding audit objective (Annex 3)
- Multi-site requirements for Feed Responsibility Assurance have been added (Annex 4 GMP+ C6)
- The Annex for the applicable documents have been harmonized (Annex 5).
This is an entirely new document based on the integrity police published by GMP+ International at the end of 2014 on the website (link). As follow-up, GMP+ International has chosen to withdraw the GMP+ C2 on the day of publication of the GMP+ C11, effective immediately.
In the new version of this document, references have been adjusted and textual adjustments have been made. No significant changes have been implemented.
Each document has included in the History of the document table the implementation date of these new (clarification) requirements. For the implementation of the use of the new GMP+ certificate template (combined with temporary acceptance), this is applicable as from the 1 Jan 2017 but it must be implemented at the beginning of each certification cycle (recertification audit).
Due to the translations the Dutch and German version of the documents will be published later this year.