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. All analytical testing to be performed by Paragon shall be specified and agreed to in advance and included in the Master Manufacturing Record and in the budget for the Project.
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. 1. Contractor shall obtain from DPH, or otherwise determine, the testing requirements for all Client Agency facilities, including both scheduling and analytical criteria.
Analytical Testing. XXXXXXX will require analytical tests to be performed in accordance with current standard characterization techniques (e.g., standard methods, ACM, EPA methods) established by the XXXXXXX contract laboratory’s SOP and QA/QC Manual.
Analytical Testing. The analytical testing will consist of aggressive air sampling for the asbestos cleanup. The analytical testing for asbestos will be performed in accordance with established regulatory clearance criteria for asbestos cleanup. Table 1: Analytical Testing M aterial Parameter M ethod Asbestos Air Samples NIOSH 7400 Asbestos Air Samples AHERA 40 CFR Part 763 Appx. A, Subpart E During the asbestos cleanup, daily air samples will be collected, at a minimum in the following locations: inside containment, outside containment, negative air exhaust, and clean room of the decontamination system. Sample locations will vary daily based on contractor containment setup and daily work areas. At the conclusion of the cleanup, after the asbestos removal has been visually verified, aggressive air clearance sampling will be conducted inside the containment area. The air samples will be collected and analyzed by Phase Contrast Microscopy (PCM) in accordance with the National Institute for Occupational Safety and Health (NIOSH) Method 7400. Final clearance sampling after the removal of regulated asbestos-containing materials will be analyzed by Transmission Electron Microscopy (TEM) in accordance with AHERA (40 CFR Part 763 Appendix A, Subpart E). In addition, throughout the cleanup of the asbestos, the contractor will be required to comply with the following applicable Occupational Safety and Health Administration (OSHA) regulation: Asbestos Standard 29 CFR 1926.1101.
