Analytical Testing. Except as otherwise contemplated by this Agreement or expressly set forth in the Quality Agreement, Lonza shall not perform any analytical testing on Bulk Drug unless agreed to by Lonza and Trubion.
Analytical Testing. The Government requires the contractor to be compliant with the UFP QAPP format for all Work Plans prepared under this contract. Chemical analytical tests shall conform to the site-specific UFP-QAPP/Work Plan and the most current version of the Department of Defense Quality Systems Manual (DOD QSM). All methods must comply with USEPA SW-846 approved sampling methods following the Test Methods for Evaluating Solid Waste, Physical/Chemical Methods (USEPA 2007) to provide definitive level quantitative analytical data. All test methods must meet the reporting limit required by Human Health Risk assessment (HHRA) for soil and groundwater and Ecological Risk Assessment (ERA) criteria for soil and groundwater using USEPA SW-846 test methods producing the lowest reporting limits. Data may be required to be entered into program specific databases, such as FUDSCHEM or other military program databases.
Analytical Testing. The Contractor shall perform analytic testing to validate the usability of the data within the data warehouse and associated data marts. Analytically usability shall be measured in terms of conformance to external standards or internal consistency.
Analytical Testing. NEKTAR AL will perform testing in accordance with its established methods and procedures and will review the results against defined specifications. Changes to these methods and procedures will be consistent with NEKTAR AL’S CHANGE CONTROL procedure. Deviations to the test methods and procedures and out-of-SPECIFICATIONS test results on the SELECTED REAGENT will be handled in a manner consistent with Section 6.4 of this QUALITY AGREEMENT.
Analytical Testing. CBSB, or a designated Subcontractor approved in accordance with Section 4.10, shall perform the analytical testing on Drug Substance as set forth in the Master Production Record, or as otherwise agreed in writing by CBSB and Tercica.
Analytical Testing. FibroGen, or a designated Subcontractor, shall perform the analytical testing on Raw Materials and Bulk Drug Products as set forth in the Specifications and Quality Agreement, and/or as otherwise agreed to in a signed writing by FibroGen and AstraZeneca.
Analytical Testing. All analytical testing to be performed by Paragon shall be specified and agreed to in advance and included in the Product Specification and in the budget for the Project.
Analytical Testing. 7.3.1 NEKTAR AL will have written procedures describing the identification, quarantine, handling, sampling, testing and approval or rejection of raw materials. NEKTAR AL will perform testing in accordance with its established methods and procedures and will review them against defined specifications. Changes to these methods and procedures will be consistent with NEKTAR AL’S CHANGE CONTROL procedure. Deviations to the test methods and procedures and out-of-SPECIFICATIONS test results on the SELECTED REAGENT will be handled in a manner consistent with Article 2 of this QUALITY AGREEMENT.
Analytical Testing. Except as otherwise contemplated by this Agreement or ------------------ expressly set forth in the Quality Agreement, Genentech shall not perform any analytical testing on Bulk Drug unless agreed to by Genentech and Immunex.
Analytical Testing. Xxxxxx shall perform analytical testing on the Client Supplied Components in accordance with the Quality Agreement, and shall inform Client of any failure of the Client Supplied Components to conform to the Specifications, as set forth in the Quality Agreement. Xxxxxx shall not be obligated to process any Client-Supplied Components that fail such testing, except upon mutual written agreement of the parties including appropriate waivers and indemnifications by Client. Xxxxxx shall inform Client of any failure of the Client Supplied Components to conform to the Specifications promptly after discovering such failure in accordance with the Quality Agreement. The disposition of such Client Supplied Components shall be determined in accordance with the Quality Agreement. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
