Packaging Component Vendors. (i) If the Client stipulates a packaging component vendor, the Client will audit and approve the manufacturer and ensure cGMP compliance. The Client stipulated vendor(s) will be included on the approved vendor list (Appendix D). (ii) If Patheon stipulates the packaging component vendor, Patheon will audit and approve the vendor and ensure cGMP compliance in accordance with Patheon’s SOP. The Patheon stipulated vendor(s) will be included on the approved supplier list (Appendix C).
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Sources: Master Manufacturing Services Agreement (Horizon Pharma, Inc.), Quality Agreement (Jaguar Animal Health, Inc.)
Packaging Component Vendors. (ii.) If the Client stipulates a packaging component vendor, the Client will audit and approve the manufacturer and ensure cGMP compliance. The Client stipulated vendor(s) will be included on the approved vendor list (attached hereto as Appendix D).
(ii.) If Patheon stipulates the packaging component vendor, Patheon will audit and approve the vendor manufacturer and ensure cGMP compliance in accordance with Patheon’s SOP. The Patheon stipulated vendor(s) will be included on the approved supplier list (Appendix C).
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