My remark is actually a question on chapters 1.3 and 1.4 of Appendix 16: before I plan to confirm the GMP of a PQ for a previous manufacturing step, the final PQ should have accepted the PQ quality system from the previous manufacturing stage (1.3 … quality pharmaceutical systems…) ? This would mean that in addition to the written agreement requested in 1.4.3 between the QPs, the final PQ would have to evaluate the PQ quality system from the previous manufacturing stage, for example.B. by examining the quality system of the “previous” PQ. Do I understand? Thank you for your remark, Claudio Annex 16 is still in its infancy and the 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. 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. Part 1 of this article dealt with the PQ`s authorisation process, the difference between the PQ declaration and pq certification and the PQ`s agreements to the PQ. This section provides a more in-depth focus on anticipating the requirements of the PQ by integrating QPs at an early stage and establishing a collaborative working relationship based on an understanding of their role and the legal context to which they must comply. 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.). 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.
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