A quality assurance clause in a contract outlines the standards and procedures that a party must adhere to in order to ensure that goods or services meet predetermined quality requirements. It typically includes provisions for inspection, testing, and compliance with industry standards to maintain and verify quality throughout the duration of the contract.
Quality Assurance Agreement. The Parties shall agree upon and execute a quality assurance agreement to cover the manufacture, supply and production of Bulk Drug Product(s) by FibroGen to AstraZeneca and other responsibilities of the Parties with respect to Finished Product pursuant to the requirements set forth in the Collaboration Agreement (“Quality Assurance Agreement”), as may be amended from time to time by a signed writing of the Parties. The Quality Assurance Agreement shall set forth the responsibilities of the Parties with respect to quality assurance, document retention, notification obligations, audit and inspection rights, and similar matters with respect to the manufacture of Product and Finished Product (as applicable) including Finished Product recalls and withdrawals, returned goods, and authorization for Finished Product recalls, and other such matters as described in Exhibit K of the Collaboration Agreement (“Quality Matters”). The Parties agree that the Quality Assurance Agreement shall be amended prior to the inclusion of Finished Product intended to be manufactured for markets other than Territory. AstraZeneca agrees to provide FibroGen with written notification at least [*] prior to AstraZeneca’s filing of Regulatory Filings (including marketing authorization applications) in such other markets. A breach of the Quality Assurance Agreement constitutes a breach of this Agreement. If there is any inconsistency between the Quality Assurance Agreement and this Agreement, the Quality Assurance Agreement shall take precedence for all quality matters and this Agreement for all other matters.
Responsibility for Quality Assurance and Quality Control. Responsibility for quality assurance and quality control of Bulk Drug Product shall be allocated between AstraZeneca and FibroGen as set forth in the Quality Assurance Agreement.
Audits. AstraZeneca shall carry out audits pursuant to the Quality Assurance Agreement.
ANALYSIS OF QUALITY ASSURANCE ASSESSMENT 1. Determining Performance 1.1. Government shall use the monitoring methods cited to determine whether the milestone deliverables have been met. If the contractor has not met milestone deliverable, it may be asked to develop a corrective action plan to show how and by what date it intends to meet the milestone deliverable. Failure to meet the milestone deliverable may result in a delay of the milestone payment and may put future milestone payments at risk.
Reporting. At the end of each contract month, the COR will prepare a written report summarizing the overall results of the quality assurance surveillance of the contractor’s performance. This written report will become part of the QA documentation. It will enable the government to demonstrate whether the contractor is meeting the stated objectives.
Quality Assurance Agreement. Within thirty (30) days after the Effective Date of this Agreement, but in any event before any supply of COMPANY Compound hereunder, the Parties (or their respective Affiliates) shall enter into a quality assurance agreement that shall address and govern issues related to the quality of the COMPANY Compound to be supplied by COMPANY for use in the COMPANY Arm (the “Quality Assurance Agreement”). In the event of any inconsistency between the terms of this Agreement and the Quality Assurance Agreement, the terms of the Quality Assurance Agreement shall control with respect to the Parties’ roles and responsibilities regarding quality requirements for the Manufacture, storage and supply of the COMPANY Compound and the terms of this Agreement shall control all other terms. The Quality Assurance Agreement shall, with respect to the COMPANY Compound: (a) detail classification of COMPANY Compound found to have a Non-Conformance; (b) include criteria for release of the COMPANY Compound and related certificates and documentation; (c) include criteria and timeframes for Delivery and acceptance of the COMPANY Compound; and (d) include provisions governing the recall and/or retrieval of the COMPANY Compound.
The fair value of quality assurance commitment upon loan origination is released as guarantee income systematically over the term of the loans subject to quality assurance commitment.
Within 5 days of the signing of this Agreement, both Parties agree to execute a quality assurance agreement (the "Quality Assurance Agreement") to set forth the quality control and quality assurance obligations of both Parties in compliance with applicable laws and regulations. At a minimum this shall include but not be limited to guidelines for Product to meet required Health Canada testing compliance.
Quality assurance (QA) is a systematic process designed to ensure that a product or service meets specified requirements and standards. It involves the implementation of processes and procedures that focus on error prevention and continual improvement. QA is typically employed in various sectors including manufacturing, software development, healthcare, and many others, to ensure reliability, safety, and consistency in the output.
Quality assurance should be used throughout the entire lifecycle of a project or process to ensure that the deliverables meet quality standards. It is especially crucial during:
To write effective quality assurance procedures, follow these steps:
Example:
Objective: Ensure all software updates undergo thorough testing before deployment.
Procedure Description:
- Code review by at least two developers.
- Execute unit tests and confirm results.
- Conduct integration tests to ensure system integrity.
- Perform user acceptance testing (UAT) with end users.
- Document all test results and obtain approvals before production deployment.
Quality assurance clauses are often included in a variety of contracts, such as:
In each type of contract, the QA clauses typically detail the expectations for quality, methods of assessment, and repercussions for failing to meet the specified standards.
Try our AI contract analysis and extract important clauses and information from existing contracts.
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