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GMP+ International starts Registered Laboratories program
21 Februar 2018
Reliable laboratory analyses are crucial for a strong and trustworthy feed safety chain. Inaccurate or false analysis results will undermine the faith in the strength of our feed safety chain, as well as endanger feed safety itself. In fact, several incidents, related to inaccurate analysis results, have occurred over the years, which led to confusion and stress among companies within the feed chain. Therefore, after careful consideration, GMP+ International has decided to start the Registered Laboratories program. Starting July 1, 2019, laboratories that analyze critical contaminants for GMP+ FSA certified companies, shall be GMP+ registered.
Attention: Early access for Certification Bodies
We are hereby sharing with you, beforehand, the new standard ‘GMP+ B11’ and its appendix ‘BA11’. These new documents will be published on March 1, 2018 to our GMP+ community. Please do not share this information with your customers before this date.
This early access gives you time to prepare and better guide your customers that will be impacted by this new FSA requirement. Please read the new documents carefully, to be fully prepared for the upcoming change.
As an attachment to the email you’ve received, you will also find a FAQ list, based on the main questions that were raised during group sessions with our stakeholders.
What is the GMP+ Registered Laboratory program?
Laboratories that analyze critical contaminants for GMP+ FSA certified companies (B1, B1.2, B2 and B3), shall be GMP+ registered, starting July 1, 2019. GMP+ International, together with our stakeholders, developed a new standard, appendix:
- GMP+ B11: standard containing the requirements for registration and verification of laboratories;
- GMP+ BA11: appendix containing the performance criteria for registered laboratories, based on European legislation and ISO standards.
GMP+ International also developed a list of Frequently Asked Questions: GMP+ D3.21. This is a support document with guidelines to help companies with the implementation of the new requirements.
This new program is exclusively meant for four (4) critical contaminants, being:
- aflatoxin B1,
- dioxins/dioxin-like PCBs/ non-dioxin-like PCBs,
- heavy metals, and
Laboratories can choose for which of the contaminants they want to register for. GMP+ Registered Laboratories shall meet the following performance criteria for their contaminant(s) of choice:
- LOQ (limit of quantification),
- Bias, and
- Measurement uncertainty.
They also shall participate in Proficiency testing.
What do GMP+ FSA Certified Companies need to do?
For companies that are GMP+ FSA B1, B1.2, B2 or B3 certified, this change means that from July 1, 2019, they can only use GMP+ Registered Laboratories for the analysis of the critical contaminants.
How do laboratories apply for the GMP+ Registered Laboratories program?
Laboratories can apply for GMP+ registration through a GMP+ Certification Body that is qualified for Registered Laboratories scope as from 1st of June 2018. Primarily, audits will be carried out by desk study. On-site audits will be carried out if doubts arise.
How do Certification Bodies become accepted for this new scope?
More information about how to become accepted for this scope will be sent out in April. At the moment, C-doc are being adapted/consulted with the new requirements of the B11.
Mar. 2018 Publication of GMP+ B11 and GMP+ BA11 on the GMP+ portal.
Mar. 2018 Laboratories can start preparing and implementing.
Jun. 2018 Publication of new requirements for GMP+ FSA certified companies in GMP+ B1, B1.2, B2 and B3.
Jun. 2018 Laboratories can apply for registration at Certification Bodies.
Jul. 2019 GMP+ FSA certified companies must use GMP+ registered laboratories.
Questions? Let us know.
We are convinced that this change to our GMP+ FSA module will have an enormous positive impact on both feed safety and the trust in our valued chain approach. All GMP+ FSA certified companies will benefit from it.