Appendix 16 also mentions the existence of Mutual Recognition Agreements (MRAs). It is important to note that the scope of this MRA does not extend in all cases to the production of PMI, for example. B the agreements with Japan and Israel do not contain any PMI, and the agreement with Australia does not contain a PMI for Phase I studies. For more information, visit this page of the EMA website. Particular attention is paid to the approval of Schedule 16 test reports. For sponsors who produce with third parties, this can be a particular challenge, as verification of PQ audit reports is probably not established in your confidentiality agreements with third parties. Expect a push-back from third-party partners and balance QP verification requirements with third-party fears. Appendix 16 is still in its infancy and expectations of the PQ will continue to grow. Don`t be surprised if your PQ`s expectations change during the PQ exit process.

Therefore, take everything in writing, update your quality agreements to include QP exit activities, and most importantly, be patient and leave plenty of time. Sometimes the QPs refuse to conclude such an agreement. In this case, it is important to work through an agreement between your company and each QPs so that the spirit of the “PQ to QP” agreement is maintained. It is also important to include it in all quality agreements in order to circumvent any impact on the publication of the PQ. Thank you very much for your request. If an intermediate certification of the PQ is taken into account by the final pq certification, there is no specific requirement for the final PQ to personally review the quality assurance system of the other PQ, but the final PQ is expected to exercise caution and understanding of the compliance status of the intermediate site. Aspects such as, but not limited, such as: – the corresponding approved forms and presentation activities included in the intermediate site manufacturer`s approval and the associated GMP certificate – visibility of test reports relevant to intermediate site approval – relevant deviations for each batch – general installation and system failures that may occur at the time of specific batch production , but which may have an impact on the lot – relevant amending controls – appropriate responsibilities, in written agreements between the organisations concerned and the GQs.