Quality Release definition

Quality Release means certification by Takeda’s quality control department that Drug Substance Manufactured by or on behalf of Takeda complies with the Quality Agreement and Takeda’s quality release specifications as confirmed by release testing.
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Quality Release means certification by Supplier’s quality control department that each Product that is Manufactured by or on behalf of Supplier complies with the Quality Agreement and Supplier’s quality release specifications as confirmed by release testing.
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Quality Release means an improvement that is specific to a single or small number of issues or errors, may not have general availability, and may be released out-of-cycle from a fully QA-ed release that results in a version number change. A “Patch release” would be a type of Quality release.
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Examples of Quality Release in a sentence

  • The program for control of QA records for NSSS suppliers is described in Reference [1] and Section 17.1.1.3. In addition, the data packages in support of the Westinghouse Quality Release are forwarded to SCE&G for retention and storage at the Virgil C.

  • When the requirement exists for a WOI, COI, or Quality Release (in the case of Westinghouse equipment), safety-related hardware cannot be accepted onsite without appropriate documentation.

  • Prior to delivery by Takeda pursuant to Section 7.1, Takeda shall undertake release testing to obtain a Quality Release for each batch of the Drug Substance or Drug Product that is Manufactured pursuant to a Purchase Order accepted by Takeda.

  • Westinghouse forwards the QA data package in support of their Quality Release to SCE&G within 120 days of the final shipment on orders for the Virgil C.

  • For that purpose, when a customer a pays a customer b, it needs to provide its bank A with the name of the bank B of customer b so that the loop can be identified.

  • Prior to delivery by Takeda pursuant to Section 8.1 hereof, Takeda shall undertake release testing to obtain a Quality Release for each batch of the Drug Substance that is Manufactured pursuant to a Purchase Order and in accordance with the terms of the Quality Agreement.

  • With each batch of Drug Substance delivered by Takeda pursuant to Section 8.1 hereof, Takeda shall provide all Batch Documentation for such batch, including a certificate of analysis, Quality Release and certificate of conformance, in accordance with the terms of the Quality Agreement.

  • Southern Company may require re-inspection prior to shipping and reserves the right to hold Quality Release for Shipment until documentation is received showing that all open items have been corrected.

  • Shipments shall be released using a Quality Release for Shipment form when required by the procurement documents.

  • The contributions, the rate, timing and payment of same shall be made in accordance with Article 10.01(b) above.

Related to Quality Release

  • Quality Agreement has the meaning set forth in Section 9.6.

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

  • Quality system means documented organizational procedures and policies: internal audits of those policies and procedures: management review and recommendation for quality improvement.”

  • Quality Assurance Program means the overall quality program and associated activities including the Department’s Quality Assurance, Design-Builder Quality Control, the Contract’s quality requirements for design and construction to assure compliance with Department Specifications and procedures.

  • Quality Improvement means a focus on activities to improve performance above minimum standards and reasonably expected levels of performance, quality and practice.

  • Quality Surveillance Engineer / Inspector means any person appointed by or on behalf of the Purchaser to inspect or carry out quality surveillance on supplies, stores or work under the Contract or any person deputed by the Quality Surveillance Engineer for the said purpose.

  • Quality Assurance Plan or “QAP” shall have the meaning set forth in Clause 11.2;

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Quality Manager means the individual identified by the Design-Builder who is responsible for the overall Quality Control program and Quality Control activities of the Design-Builder, including the quality of management, design and construction. (also referred to as the “Quality Control Manager”).

  • Quality Plan means the quality plan to be produced by the Contractor in accordance with Schedule S2-10 (Quality Plan);

  • Product Specific Terms means the terms applicable to a specific item of Licensed Software as set out in Schedule 2;

  • Review Package A package of documents consisting of a memorandum outlining the analysis and recommendation (in accordance with the Servicing Standard) of the Master Servicer or the Special Servicer, as the case may be, with respect to the matters that are the subject thereof, and copies of all relevant documentation.

  • Particulate matter emissions (PM) means the mass of any particulate material from the vehicle exhaust quantified according to the dilution, sampling and measurement methods as specified in this UN GTR.

  • quality (functionality means the totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs F.1.4 Communication and employer’s agentEach communication between the employer and a tenderer shall be to or from the employer's agent only, and in a form that can be read, copied and recorded. Writing shall be in the English language. The employer shall not take any responsibility for non-receipt of communications from or by a tenderer. The name and contact details of the employer’s agent are stated in the tender data. F.1.5 The employer’s right to accept or reject any tender offer F.1.5.1 The employer may accept or reject any variation, deviation, tender offer, or alternative tender offer, and may cancel the tender process and reject all tender offers at any time before the formation of a contract. The employer shall not accept or incur any liability to a tenderer for such cancellation and rejection, but will give written reasons for such action upon written request to do so. F.1.5.2 The employer may not subsequent to the cancellation or abandonment of a tender process or the rejection of all responsive tender offers re-issue a tender covering substantially the same scope of work within a period of six months unless only one tender was received and such tender was returned unopened to the tenderer. F.2 Tenderer’s obligations F.2.1 EligibilitySubmit a tender offer only if the tenderer satisfies the criteria stated in the tender data and the tenderer, or any of his principals, is not under any restriction to do business with employer. F.2.2 Cost of tenderingAccept that the employer will not compensate the tenderer for any costs incurred in the preparation and submission of a tender offer, including the costs of any testing necessary to demonstrate that aspects of the offer satisfy requirements. F.2.3 Check documentsCheck the tender documents on receipt for completeness and notify the employer of any discrepancy or omission. F.2.4 Confidentiality and copyright of documentsTreat as confidential all matters arising in connection with the tender. Use and copy the documents issued by the employer only for the purpose of preparing and submitting a tender offer in response to the invitation. F.2.5 Reference documentsObtain, as necessary for submitting a tender offer, copies of the latest versions of standards, specifications, conditions of contract and other publications, which are not attached but which are incorporated into the tender documents by reference. F.2.6 Acknowledge addendaAcknowledge receipt of addenda to the tender documents, which the employer may issue, and if necessary apply for an extension to the closing time stated in the tender data, in order to take the addenda into account. F.2.7 Clarification meetingAttend, where required, a clarification meeting at which tenderers may familiarize themselves with aspects of the proposed work, services or supply and raise questions. Details of the meeting(s) are stated in the tender data. F.2.8 Seek clarificationRequest clarification of the tender documents, if necessary, by notifying the employer at least five working days before the closing time stated in the tender data. F.2.9 InsuranceBe aware that the extent of insurance to be provided by the employer (if any) might not be for the full cover required in terms of the conditions of contract identified in the contract data. The tenderer is advised to seek qualified advice regarding insurance. F.2.10 Pricing the tender offer F.2.10.1 Include in the rates, prices, and the tendered total of the prices (if any) all duties, taxes (except Value Added Tax (VAT), and other levies payable by the successful tenderer, such duties, taxes and levies being those applicable 14 days before the closing time stated in the tender data. F2.10.2 Show VAT payable by the employer separately as an addition to the tendered total of the prices.

  • QA means Quality Assurance.

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Feasibility Report means a detailed written report of the results of a comprehensive study on the economic feasibility of placing the Property or a portion thereof into Commercial Production and shall include a reasonable assessment of the mineral ore reserves and their amenability to metallurgical treatment, a description of the work, equipment and supplies required to bring the Property or a portion thereof into Commercial Production and the estimated cost thereof, a description of the mining methods to be employed and a financial appraisal of the proposed operations supported by an explanation of the data used therein;

  • Quality improvement organization or “QIO” shall mean the organization that performs medical peer review of Medicaid claims, including review of validity of hospital diagnosis and procedure coding information; completeness, adequacy and quality of care; appropriateness of admission, discharge and transfer; and appropriateness of prospective payment outlier cases. These activities undertaken by the QIO may be included in a contractual relationship with the Iowa Medicaid enterprise.

  • Quality Assurance means a systematic procedure for assessing the effectiveness, efficiency, and appropriateness of services.

  • Product Specifications means those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

  • Defect Notice shall have the meaning specified in Section 3.2 of this Agreement.

  • Particulate Matter (PM means the particles found in the exhaust of CI engines, which may agglomerate and adsorb other species to form structures of complex physical and chemical properties.

  • High Quality Waters means all state waters, except:

  • Review Criteria has the meaning assigned to that term in Section 12.02(b)(i).

  • extended producer responsibility ’ (EPR) means responsibility of any producer of packaging products such as plastic, tin, glass, wrappers and corrugated boxes, etc., for environmentally sound management, till end-of-life of the packaging products ;

  • Brand Name Specification means a specification limited to one or more items by manufacturers’ names or catalogue number.