Vendor Audit Responsibility. Excipient and API Vendors:
(i.) If the Client stipulates an excipient or API vendor, the Client will audit and approve the manufacturers 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 (attached hereto as Appendix D).
(ii.) If Patheon stipulates the excipient vendor, 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). Packaging Component Vendors:
(i.) If the Client stipulates 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 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).
Vendor Audit Responsibility. (For the purposes of this Section the term “Vendor” refers to the sites performing the manufacturing and testing of a material). Excipient, Packaging Component, and API Vendors:
(i.) If the Client stipulates a Vendor, the Client will audit and approve the Vendor and ensure cGMP compliance in accordance with Section 4.3.4 of this Agreement. If Patheon is to release an API or other Client stipulated material based on “ID Only”, the Client will ensure the required verification testing by an independent laboratory has been completed. The Client stipulated Vendor(s) will be included on the Client’s approved Vendor list (attached hereto as Appendix D).
(ii.) If Patheon stipulates a Vendor, 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).
(iii.) Upon request by any regulatory body audits of API manufacturing sites should be available to both parties.
Vendor Audit Responsibility. CPI’s Quality unit will audit and approve all CPI vendors engaged in the manufacturing, packaging and distribution activities to ensure compliance with Section 3.3 of the Agreement and SOPs. CPI’s stipulated vendor(s) will be included on the approved vendor list as outlined in Appendix C, which may be amended from time to time as mutually agreed upon by the Parties.
Vendor Audit Responsibility. SUPPLIER is responsible for vendor quality assessment of SUPPLIER furnished materials (i.e.: raw materials, packaging and labeling components) and SUPPLIER’s service providers. SUPPLIER will audit and approve the vendor and ensure cGMP compliance in accordance with SUPPLIER’s SOPs. SUPPLIER shall not alter or change vendor without the prior written notice to and approval of SUPERNUS, which may be withheld or granted in its sole and absolute discretion.
Vendor Audit Responsibility. 4.3.3.1 Excipient, Component and API Vendors:
(i.) MDCO is responsible for the API vendor. MDCO will approve the API manufacturer/s and will inform Patheon about the approval status. MDCO will be also responsible for providing PATHEON with a proof of API manufacturer/s compliance with EU GMP Part II and will ensure the API cGMP compliance in accordance with Section 4.3.4 of this Agreement. The MDCO stipulated vendor(s) will be included on MDCO’s approved vendor list (attached hereto as Appendix D). (ii.) PATHEON is responsible for Components and excipient vendors. PATHEON will be responsible for approving the manufacturers and for ensuring their cGMP compliance in accordance with Patheon SOP. The PATHEON stipulated vendor(s) will be included on PATHEON’s approved vendor list (attached hereto as Appendix C).
Vendor Audit Responsibility
