Excipient and API Vendors Sample Clauses
Excipient and API Vendors. (i) If the Client stipulates an excipient or API vendor, the Client will audit and approve the vendor and ensure cGMP compliance in accordance with Section 4.3.4 of this Agreement. The Client stipulated vendor(s) will be included on the Client’s approved vendor list (Appendix D).
(ii) If Patheon stipulates the excipient vendor, Patheon will audit and approve the vendor and ensure cGMP compliance in accordance with Patheon’s SOPs. The Patheon stipulated vendor(s) will be included on Patheon’s approved vendor list (Appendix C).
Excipient and API Vendors. (i) If Cangene is responsible for supplying an excipient or API, Cangene will audit and approve the manufacturers and ensure cGMP and cGDP compliance in accordance with Section 4.3.4 of this Agreement. Cangene stipulated vendor(s) will be included on Cangene’s approved vendor list (attached hereto as Appendix D). Cangene will provide to Patheon all documentation related to API identified in Appendix H.
(ii) If Patheon is responsible for procuring the excipient, Patheon will audit and approve the manufacturers and ensure cGMP compliance in accordance with Patheon’s SOP. The Patheon stipulated vendor(s) will be included on Patheon’s approved vendor list (attached hereto as Appendix C).