ASSURANCE; QUALITY CONTROL; VALIDATION; STABILITY Sample Clauses

ASSURANCE; QUALITY CONTROL; VALIDATION; STABILITY. 11.1 Responsibility for Quality Assurance and Quality Control. Responsibility -------------------------------------------------------- for quality assurance and quality control of Bulk Drug shall be allocated between Immunex and Genentech as set forth in the Quality Agreement and in standard operating procedures agreed upon in writing by Immunex and Genentech from time to time. In general, (a) Genentech shall be responsible for performing certain in-process testing and selected acceptance testing on the Bulk Drug as set forth in the Tech Transfer Agreement and the Quality Agreement, and (b) Immunex shall be responsible for all final acceptance testing and authorizing final release of all Bulk Drug. In the event the Parties disagree on whether a Batch shall be released, the dispute shall be resolved in compliance with the provisions set forth in Section 8.1 hereof. ------------------
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ASSURANCE; QUALITY CONTROL; VALIDATION; STABILITY. 11.1 Quality Agreement; Responsibility for Quality Assurance and Quality Control.
ASSURANCE; QUALITY CONTROL; VALIDATION; STABILITY. 11.1 RESPONSIBILITY FOR QUALITY ASSURANCE AND QUALITY CONTROL. Responsibility for quality assurance and quality control of Bulk Drug Substance, Drug Product and Finished Product shall be allocated between Buyer and BIP as set forth in standard operating procedures agreed upon by Buyer and BIP from time to time. In general, (a) BIP shall be responsible for performing a manufacturer's lot release on all Bulk Drug Substance, Drug Product and Finished Product and (b) Buyer shall be responsible for performing final release of all Bulk Drug Substance, Drug Product and Finished Product.
ASSURANCE; QUALITY CONTROL; VALIDATION; STABILITY 

Related to ASSURANCE; QUALITY CONTROL; VALIDATION; STABILITY

  • Quality Assurance/Quality Control Contractor shall establish and maintain a quality assurance/quality control program which shall include procedures for continuous control of all construction and comprehensive inspection and testing of all items of Work, including any Work performed by Subcontractors, so as to ensure complete conformance to the Contract with respect to materials, workmanship, construction, finish, functional performance, and identification. The program established by Contractor shall comply with any quality assurance/quality control requirements incorporated in the Contract.

  • Use; Quality Control a. Neither party may alter the other party’s trademarks from the form provided and must comply with removal requests as to specific uses of its trademarks or logos.

  • COUNTY’S QUALITY ASSURANCE PLAN The County or its agent will evaluate the Contractor’s performance under this Contract on not less than an annual basis. Such evaluation will include assessing the Contractor’s compliance with all Contract terms and conditions and performance standards. Contractor deficiencies which the County determines are severe or continuing and that may place performance of the Contract in jeopardy if not corrected will be reported to the Board of Supervisors. The report will include improvement/corrective action measures taken by the County and the Contractor. If improvement does not occur consistent with the corrective action measures, the County may terminate this Contract or impose other penalties as specified in this Contract.

  • Indoor Air Quality The Employer shall ensure a healthful air quality and attempt to ensure comfortable air temperature in buildings it owns and in space that it leases.

  • Quality Control A. Controlled Affiliate agrees to use the Licensed Marks and Name only in connection with the licensed services and further agrees to be bound by the conditions regarding quality control shown in attached Exhibit A as they may be amended by BCBSA from time-to-time.

  • Air Quality To the extent applicable, Consultant must fully comply with all applicable laws, rules and regulations in furnishing or using equipment and/or providing services, including, but not limited to, emissions limits and permitting requirements imposed by the South Coast Air Quality Management District (SCAQMD) and/or California Air Resources Board (CARB). Although the SCAQMD and CARB limits and requirements are more broad, Consultant shall specifically be aware of their application to "portable equipment", which definition is considered by SCAQMD and CARB to include any item of equipment with a fuel-powered engine. Consultant shall indemnify City against any fines or penalties imposed by SCAQMD, CARB, or any other governmental or regulatory agency for violations of applicable laws, rules and/or regulations by Consultant, its subconsultants, or others for whom Consultant is responsible under its indemnity obligations provided for in this Agreement.

  • Musculoskeletal Injury Prevention and Control (a) The Hospital in consultation with the Joint Health and Safety Committee (JHSC) shall develop, establish and put into effect, musculoskeletal prevention and control measures, procedures, practices and training for the health and safety of employees.

  • Human and Financial Resources to Implement Safeguards Requirements 10. The Borrower shall make available or cause the State and the DISCOMs to make available necessary budgetary and human resources to fully implement the EMP, the RP and any IPP.

  • Quality Control Program The Contractor shall describe the Quality Control Program in a written document which shall be reviewed by the Engineer prior to the start of any production, construction, or off-site fabrication. The written Quality Control Program shall be submitted to the Engineer for review at least ten (10) calendar days before the start of construction. The Quality Control Program shall be organized to address, as a minimum, the following items:

  • Water Quality 8.1. The Supply shall comply with the quality standards imposed by the Act and the Water Quality Regulations, PROVIDED ALWAYS that where a particular standard is the subject of a legal instrument accepted or issued by the Secretary of State or the Chief Inspector of Drinking Water under the provisions of the Act or the Water Quality Regulations, compliance with the terms of the relevant legal instrument shall be deemed to be compliance with the relevant quality standard imposed by the Act or the Water Quality Regulations (as the case may be), in which case the Water Company shall provide the New Appointee with a certified copy of any such authorised departure or undertaking. Each party undertakes to keep the other party fully informed of any discussions which take place at any time hereafter with the Secretary of State for the proposed issue of a legal instrument and of the outcome thereof.

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