Changes in the GMP+ Registered laboratory program
16 May 2019
In collaboration with the International Expert Committee, the GMP+ International community has implemented changes in the GMP+ Registered Laboratory program. These changes are necessary to explain the requirements and to create alignment with the daily business of the participants. GMP+ International will implement these changes in the relevant documents and on the website.
Extension of the period for registration
In 2018 GMP+ International announced that as of July 1st 2019, Laboratories that analyze critical contaminants must be GMP+ Registered laboratories. For more information, go to GMP+ Website.
This long implementation period was chosen to give companies and laboratories the opportunity to adapt to these requirements. To date, a lot of laboratories have already been registered, after demonstrating they comply with the requirements, laid down in GMP+ B11 and GMP+ BA11. In addition, a lot of laboratories have applied for registration, but their registration is still pending because the certification bodies still need to carry out an assessment. The expectation is that it will not be possible to handle all applications before July 1st 2019 and that this process will consume a couple more months after this date.
GMP+ International has monitored the current situation and asked the International Expert Committee for advice. This resulted in the following decisions:
- From July 1st 2019 through January 1st 2020, the analysis of the specific parameters can be carried out by a laboratory that has applied for registration at a certification body, in addition to laboratories that have already been registered. A list will be published on the GMP+ Website shortly.
- As from January 1st 2020, the analysis of the specific parameters must be carried out by a registered laboratory.
Some questions were raised about outsourcing, especially with regard to the information in the FAQ-list (GMP+ D3.21 FAQ GMP+ Registered Laboratory). It should be clear that laboratory A can outsource an analysis to laboratory B. The reason could be, for example, a lack of capacity or because laboratory B is better equipped or has more expertise for this specific analysis. In this situation, of course, laboratory B has to be registered for this specific analysis and the outsourcing should be documented. Laboratory A does not necessarily have to carry out this analysis by itself, but will get a registration for this specific analysis.
Due to practical problems with the registration of pesticides, it is decided to postpone the obligation to use a GMP+ registered laboratory for pesticide analyses until further notice. Up to now, a laboratory could become registered if all pesticide analyses he performs comply with the performance criteria. However, in practice, this approach has not proven feasible, because some laboratories are unable or unwilling to bring one or more pesticide analyses under the registration. For example, because a laboratory is unable or unwilling to make the investments necessary to comply with the performance criteria. At the same time, feed companies normally do not ask for testing on specific individual pesticides. Instead they ask laboratories to test their feed on packages of pesticides. For feed companies it is not feasible to verify which pesticide analysis falls under the registration of the laboratory or not.
This situation has been discussed in different committees, but no acceptable solution has been found that fits the current practice of both laboratories and feed companies. Therefore, the following is decided:
- As from July 1st 2019, carrying out an analysis of pesticides is no longer restricted to a GMP+ registered laboratory. Instead, the analysis must be carried out by a laboratory with an accepted quality management system. The accepted quality management systems are listed in GMP+ BA10 Minimum. Requirements for Purchasing in section 3.9, part B. These are laboratories certified / accredited for:
- GMP+ B10 Laboratory testing
- ISO 9001
- TASCC Facilities Testing
- Other quality assurance system (as long as the laboratory produces results in a reliable fashion and that an independent third party has assessed this positively).
- Related to the previous point, if laboratories want to bring all their pesticide analyses under the GMP+ registration and comply with the performance criteria they can still apply for registration. Feed companies are allowed to have their pesticide analyses carried out by this laboratory.
- GMP+ International will consult experts from laboratories, feed companies and certification bodies to find solutions for these practical problems related to the registration of pesticides. Once this solution has been found, we will inform the GMP+ Community about it and from which date a registered laboratory must be used for the analysis on pesticides.
50 GMP+ registered laboratories
Currently, 50 laboratories are registered. You can find the GMP+ registered laboratories in the company database. The parameters for which the laboratories are registered are not yet visible in the database. You can find that information here (click on the laboratory’s name).