The Supplier must carefully read and understand the Quality Requirements for ZTE Suppliers, ZTE Requirements for PCN Management, Requirements for Management of Quality Black-list, Requirements for Management of Secondary Supplier, and strictly comply with the ZTE quality requirements. The detailed requirements are subject to those officially published on the ZTE supply chain website https://supply.zte.com.cn.
“QA” means quality assurance.
ARTICLE # QUALITY ASSURANCE REQUIREMENTS
QUALITY ADDICTION MANAGEMENT, INC.
“Change” means any change to the Services, pricing or Scope of Work incorporated into a written amendment to the Agreement in accordance with clause 16.2 or effected in accordance with the Quality Agreement.
. recurrence of Major Quality Problems (recur means that a quality problem of the same failure mechanism recurs to materials of the same code from the same supplier within a six-month period);
3.1Quality Control. Supplier shall maintain and follow a quality control and testing program that is consistent with the Regulatory Standards and the quality standards and quality assurance plans included in the Specifications (the “Quality Control Procedures”). Supplier shall supply to Purchaser Supply Deliverables that are manufactured in accordance with Regulatory Standards. Each shipment of Supply Deliverables delivered to Purchaser shall be accompanied by a written certificate of compliance, executed by an authorized officer of Supplier, confirming that the Supply Deliverables were manufactured in accordance with the Specifications and Regulatory Standards (“Certificate of Compliance”).
Manufacture shall mean all activities related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including but not limited to test method development and stability testing, formulation, process development, manufacturing for use in non-clinical or clinical studies, manufacturing scale-up, manufacturing Licensed Compound or Licensed Product quality assurance/quality control development, quality control testing (including in-process release and stability testing), packaging, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, and regulatory activities related to all of the foregoing.
Service Provider’s Quality Assurance Program is subject to review and audit by Owners for compliance with 10 C.F.R. Part 50, and ASME NQA-1 - 1994. Owners’ right to direct the quality assurance Services shall only extend to the Quality Assurance Program procedures and manuals applicable to the Project. Direction given by Owners shall be Project-specific and shall not require Service Provider to modify its Quality Assurance Program in such a way that the modification would impact other projects or Service Provider activities not being undertaken in support of the Project.
Quality of service and/or patient care;
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