Qp Agreement

kenty9x | December 15, 2020 | 0

For example, a PQ may provide intermediate certification for the mass product, the PQ, which is designated in the manufacturer`s license for the site where the packaging, labelling and distribution takes place, achieving final QP certification for the clinical trial. In this case, a PQ agreement to the PQ facilitates the delineation of responsibilities for each PQ and complements existing technical arrangements with the parties involved in the supply chain. 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. If the responsibilities are divided between one or more QPs (for example. B separate QPs at mass production and packaging sites), these responsibilities should be clearly defined in a technical agreement. When a PQ submits confirmation of compliance with EU PMPs and the corresponding MA/CTA for partial production (for example. B to mass production), this PQ should have access to relevant parts of the MA/CTA and relevant audit reports. If the final QP certification then depends on this confirmation of the first PQ, it should not be expected that the final PQ will also need access to the same audit reports.

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. Depending on the complexity of the supply chain, more than one PQ may be involved in the PQ certification process, so U.S. sponsors must support the negotiation of PQ agreements to the PQ. As with contractual transfers of regulatory obligation transfer agreements (TOROs), qp-to-QP agreements will delineate the responsibilities of each PQ to ensure that there is no clarity on where the responsibility for each PQ begins and ends (EU GMP Part I, Chapter 7: Outsourced Activities, EU GMP Annex 16: Certification by a QP and Batch release, etc.). If you wish to carry out studies in the EU in the future, include in your quality agreement a clause allowing you to review your PQ`s audit reports for studies that extend into EU countries and are subject to the publication of the PQ. If possible, use a QP for third-party audits to circumvent questions about the acceptability of the EU audit. 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. – the corresponding approved forms and delivery activities, the visibility of relevant test reports used for intermediate site approval, relevant deviations for each batch – general failures of facilities and systems that may occur at the time of the specific production of the lot, but likely to have an impact on the lot – relevant modification controls – appropriate responsibilities defined in the written agreements between the organizations concerned.