Quality Assurance and Quality Control Clause Samples

Quality Assurance and Quality Control. 3.3.1 Promptly after the Effective Date, the Contractor shall provide quality assurance and quality control systems and quality plans for approval by the Corporation. Such systems and plans shall be in accordance with good industry practice and Field quality plans given in Schedule-II (Appendix-IV- technical specification). 3.3.2 The Contractor shall ensure, and shall procure that its sub-contractors ensure, that the Work is carried out in accordance with the quality assurance and quality control systems and quality plans approved in writing by the Corporation and any other quality assurance and quality control systems and quality plans provided to the Contractor by the Corporation. 3.3.3 All works under or in course of execution or executed in pursuance of the contract, shall at all times be open and accessible to the inspection and supervision of the Corporation and/or his authorized officers- in- charge of the work and all the superior officers, officer of the Quality Assurance Unit of the Department or any organization engaged by the Department for Quality Assurance and of the Chief Technical Examiner’s Office and the contractor shall, at all times, during the usual working hours and at all other times at which reasonable notice of the visit of such officers has been given to the contractor, either himself be present to receive orders and instructions or have a responsible agent, duly accredited in writing, present for that purpose. Orders given to the Contractor’s agent shall be considered to have the same force as if they had been given to the contractor himself. 3.3.4 If it shall appear to the Corporation or his authorized subordinates , Chief Engineer and or Other Engineers in his Office of Quality Assurance or his subordinate officers or the officers of the organization engaged by the Department for Quality Assurance or to the Chief Technical Examiner or his subordinate officers, that any work has been executed with unsound, imperfect or unskillful workmanship or with materials or articles provided by him for the execution of the work which are unsound or of a quality inferior to that contracted or otherwise not in accordance with the contract, the Contractor shall, on demand in writing which shall be made within six months (three months in the case of work costing Rs. 10 Lac and below except roadwork) of the completion of the work from the Corporation specifying the work, materials or articles complained of notwithstanding that the same may have ...

Quality Assurance and Quality Control. The quality control exercised by Seller in its manufacture of the Liquefaction Train System shall be in accordance with the standards set forth in Appendix E (Quality Assurance and Quality Control).

Quality Assurance and Quality Control. 6.1 Where Regulatory Inspections or PURCHASER audits identify quality and compliance issues SUPPLIER shall agree to implement corrective and preventative action. 6.2 SUPPLIER shall notify PURCHASER of any regulatory inspections that are announced that may directly or indirectly impact on the PRODUCTS supplied to the PURCHASER. SUPPLIER shall inform PURCHASER of adverse observations from such inspections that may directly or indirectly impact on the PRODUCTS supplied to PURCHASER . SUPPLIER shall review any responses to Regulatory Authorities with the PURCHASER that may directly or indirectly impact on the PRODUCTS prior to submission to the Regulatory Authorities by SUPPLIER. 6.3 SUPPLIER is responsible for the quality control of the PRODUCTS, including testing, documentation review, retention of samples and producing required documentation as defined in cGMPs. 6.4 SUPPLIER shall, where required, develop internal control limits in coordination and agreement with PURCHASER including limits, that support the expiry period of the PRODUCTS in the Details. Where these internal control limits are agreed, batches failing the internal control limits shall not be shipped to PURCHASER until the SUPPLIER conducts and appropriate investigation and the outcome accepted by the PURCHASER. 6.5 SUPPLIER shall supply an agreed Certificate of Analysis (COA) as defined in Appendix 6, and an agreed Certificate of Compliance (COC) as defined in Appendix 7 for PRODUCTS indicating that the batch complies with all agreed specifications and cGMPs prior to dispatch for review and assessment by the PURCHASER. 6.6 PURCHASER shall review and access Certificate of Analysis (COA) and Certificate of Conformance (COC). 6.7 PURCHASER shall confirm the identity of PRODUCTS within 60 days of receipt of PRODUCTS from SUPPLIER . PURCHASER shall undertake any additional tests, as PURCHASER deems appropriate. 6.8 SUPPLIER shall investigate all non-conformities, deviations and out of specification (OOS) results in accordance with cGMPs and shall inform the PURCHASER of the outcome of investigations. 6.9 SUPPLIER shall inform PURCHASER of any incidents that may affect conformance of the PRODUCT to the Specifications. 6.10 SUPPLIER shall retain batch documentation for 5 years. 6.11 SUPPLIER shall retain retention samples from each batch of the PRODUCTS and starting materials in accordance with cGMPs. For the subsequent stages that are conducted at the PURCHASER’s facility, PURCHASER shall retain ret...

Quality Assurance and Quality Control. The supplier shall be responsible for the purchase; storage, testing and release of raw materials used in the manufacture of the product(s) and for ensuring suppliers for such materials comply with the current specifications and suppliers own control systems and procedures. The supplied product(s) shall comply with (mutually agreed) specifications and shall be delivered in appropriate packages with labeling containing product(s) information, appropriate international hazard symbols and hazard and emergency instructions. Supplier shall maintain a Calibration system. Inspection measuring and test equipment shall be controlled, calibrated, and maintained. Calibration shall be traceable to National or International standards.

Quality Assurance and Quality Control. The Study Sponsor will secure agreement from all involved parties to ensure direct access to all study related sites, source data and documents, and reports for the purpose of monitoring and auditing by the Study Sponsor, and inspection by domestic and foreign regulatory authorities. Quality control will be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly. Agreements made by the Study Sponsor with the Investigator/Institution and any other parties involved in the clinical study will be provided in writing as part of the protocol or as a separate agreement.

Quality Assurance and Quality Control. 3.3.1 Promptly after the Effective Date, the Contractor shall provide quality assurance and quality control systems and quality plans for approval by the Corporation. Such systems and plans shall be in accordance with good industry practice and Field quality plans given in Schedule-II (Appendix-IV- technical specification).

Quality Assurance and Quality Control. The Engineer shall provide peer review at all levels. For each deliverable, the Engineer shall have some evidence of their internal review and ▇▇▇▇-up of that deliverable as preparation for submittal. A milestone submittal is not considered complete unless the required milestone documents and associated internal red-line ▇▇▇▇-ups are submitted. The State’s project manager will require the Engineer to submit the Engineer’s internal ▇▇▇▇-up (red-lines) or comments developed as part the Engineer’s quality control step. When internal ▇▇▇▇-ups are requested by the State in advance, the State, at its sole discretion, may reject the actual deliverable should the Engineer fail to provide the evidence of quality control. The Engineer shall clearly label each document submitted for quality assurance as an internal ▇▇▇▇-up document.

Quality Assurance and Quality Control. In addition to compliance with this Agreement, each Party shall fulfil its responsibilities as set out in the Quality Agreement. Subject always to the provisions of the Quality Agreement, ▇▇▇▇ will not knowingly make any modification to the Master Batch Record as validated), any other Specification, raw materials, components, or testing without the written consent of Dyax. ▇▇▇▇ agrees to inform Dyax within [*****] days of the result of any regulatory development or changes to Product Specifications that materially affect the Production of the Product. ▇▇▇▇ shall notify Dyax of and require written approval from Dyax for changes to Master Batch Records and Product Specifications prior to the Production of subsequent Batches of Product.

Quality Assurance and Quality Control. In addition to compliance with this Agreement, each Party shall fulfil its responsibilities as set out in the Quality Agreement. Subject always to the provisions of the Quality Agreement, ▇▇▇▇▇▇▇▇▇▇ will not make any modification to the Manufacturing Description (as validated), any other Specification, raw materials, components, or testing without the written consent of Dyax.