Certificates of Analysis and Manufacturing Compliance. (a) Supplier shall test or cause to be tested each lot of Product purchased pursuant to this Agreement as per the Specifications. For each lot of Product tested, each test shall set forth the items tested, specifications, and test results in a certificate of analysis, which Supplier shall send or cause to be sent to SCRIPSAMERICA. SCRIPSAMERICA is entitled to rely on such certificates for all purposes of this Agreement
(b) Supplier shall provide or cause to be provided a certificate of manufacturing compliance or manufacturing lot record that will certify that the Products were manufactured in accordance with the Specifications and applicable cGMPs.
Certificates of Analysis and Manufacturing Compliance. (a) Supplier shall test or cause to be tested each lot of Product purchased pursuant to this Agreement as per the Specifications. For each lot of Product tested, each test shall set forth the items tested, specifications, and test results in a certificate of analysis, which Supplier shall send or cause to be sent to Zicam. Zicam is entitled to rely on such certificates for all purposes of this Agreement.
(b) Supplier shall provide or cause to be provided a certificate of manufacturing compliance or manufacturing lot record that will certify that the Products were manufactured in accordance with the Specifications and applicable cGMPs.
Certificates of Analysis and Manufacturing Compliance. 5.1 Certificates of Analysis. Upshxx-Xxxxx xxxll test each lot of Product purchased pursuant to this Agreement before delivery to Ascent, and shall provide to Ascent, promptly following such tests, all documents identified in Appendix X with respect to the first **** lots of each Product and all applicable documents identified in Appendix X with respect to the first *** lots of each raw material at a cost to ****** of $****** per lot for documents relating to each Product lot and $****** per lot for documents relating to each raw material lot. Thereafter, Upshxx-Xxxxx xxxll provide to Ascent, promptly following such tests, all documents identified in Appendix Y with respect to subsequent lots of each Product and raw material, at a ************** of $****** per lot; provided that in the event that the FDA requires more extensive documentation to be included as identified in Appendix X, Upshxx-Xxxxx xxxll provide Ascent all such documentation at the cost specified immediately above in this Section 5.
1. Each Certificate of Analysis shall set forth the items tested, specifications and test results for each lot delivered. Required extraordinary reporting or documentation, outside the scope of this Agreement, may be subject to an additional charge by Upshxx-Xxxxx.
Certificates of Analysis and Manufacturing Compliance. Quality and Safety Data Exchange Agreement Not less than [***] before the [***], the parties shall enter into a mutually agreeable Quality Agreement (the “Quality Agreement”), in accordance with RENAISSANCE’ SOP’s and in conformity with any Regulatory Authority requirements and Applicable Law setting forth the parties’ obligations with regard to quality matters and Product complaints and adverse drug experiences. Until a Quality Agreement is entered into between the parties, this Agreement, in conjunction with all applicable Regulatory Authority requirements and Applicable Law, shall govern the parties’ responsibilities with respect to procedures impacting the identity, strength, quality, purity and all other aspects of the Product.
Certificates of Analysis and Manufacturing Compliance. 4.1 Certificates of Analysis: At Client’s cost and expense, Xxxxxx shall test, or cause to be tested by third parties, in accordance with the Specifications, each Batch of Client Product Produced pursuant to this Agreement before delivery to Client. Xxxxxx shall deliver a Certificate of Analysis for each Batch, which shall set forth the items tested, Specifications, and test results. Xxxxxx shall also indicate on the final page of the Released Executed Batch Record that all batch Production and control records have been reviewed and approved by the appropriate quality control unit. Xxxxxx shall send, or cause to be sent, such certificates to Client prior to the shipment of Client Product (unless Client Product is shipped under quarantine). If Client is responsible for final release testing, or if Client otherwise deems it appropriate, Client shall test, or cause to be tested, for final release, each Batch of Client Product to test for conformance to the Specifications. As required by FDA, Client assumes full responsibility for final release of each Batch of Client Product.
4.2 Manufacturing Compliance: Xxxxxx shall advise Client immediately if an authorized agent of any Regulatory Authority schedules or visits (or gives notice that it intends to schedule or visit) Althea’s manufacturing facility and makes an inquiry regarding Althea’s Production of Client Product for Client. Client shall be entitled to be present during any such inspection or visit, and shall be further entitled to attend any end of visit wrap-up meeting with such regulatory agent, if feasible. [***] Xxxxxx shall promptly provide Client with a copy of any report or findings of such Regulatory Authority relevant to Production or Client Product and of Althea’s intended response prior thereto to enable the parties to confer on such matter.
Certificates of Analysis and Manufacturing Compliance. 8 5.1 Certificates of Analysis...................................... 8 5.2 Stability Testing............................................. 8 5.3 Additional Validation Work or Additional Testing.............. 8 5.4
Certificates of Analysis and Manufacturing Compliance. 4.1 Certificates of Analysis: FAULDING shall perform, or cause to be performed, certain tests requested by CUMBERLAND as indicated in the Specifications on each batch of the Drug Product manufactured pursuant to this Agreement before delivery to CUMBERLAND.
Certificates of Analysis and Manufacturing Compliance. Each Delivery of Clinical Product, Marketed Product or API shall be accompanied by a Certificate of Analysis and a Certificate of Manufacturing Compliance, if required by applicable law, pertaining to the Clinical Product, Marketed Product or API in such shipment.
Certificates of Analysis and Manufacturing Compliance. 5.1 Certificates of Analysis: Manufacturer shall test or cause to be tested each lot of Product purchased pursuant to this Agreement as per the Specifications. For each lot of Product tested, each test shall set forth the items tested, specifications, and test results in a certificate of analysis, which Manufacturer shall send or cause to be sent to Customer. Customer is entitled to rely on such certificates for all purposes of this Agreement.
Certificates of Analysis and Manufacturing Compliance
