Quality Unit definition

Quality Unit means collectively the PPL-SD Quality Assurance and Quality Control Departments.
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Quality Unit means the department within ARIAD, MERCK or their respective Approved Manufacturers’ organization that is responsible for implementation of the Quality Assurance Systems.
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Quality Unit means the group of persons responsible for the quality and safety relating to the Product;
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Examples of Quality Unit in a sentence

  • One should be in the Quality unit and be the final approver.All changes should be performed under the Change Control procedure.

  • Product was being released by the authorized persons of the Quality unit in accordance with written procedures.

  • Methodology: The DHCFP Managed Care & Quality unit will utilize the following stratified approach for the combined Annual Waiver Review for the FE and PD waivers.

  • Responsible for drawing up the document:  Global Infrastructure and Networks: Engineering and Construction / Components and Devices Design/ Network Components Responsible for authorizing the document:  Global Infrastructure and Networks: Head of Engineering and Construction unit  Global Infrastructure and Networks: Head of Health, Safety, Environment and Quality unit.

  • Responsible for authorizing the document: • Global Infrastructure and Networks: Head of Operation and Maintenance unit; • Global Infrastructure and Networks: Head of Health, Safety, Environment and Quality unit.

  • Accordingly we have set up a Quality unit at R & D Biotechnology and Quality Management System (QMS) implementation is underway.

  • Responsible for drawing up the document:  Global Infrastructure and Networks: Operation and Maintenance / Network Components Standardization Responsible for authorizing the document:  Global Infrastructure and Networks: Head of Operation and Maintenance unit  Global Infrastructure and Networks: Head of Health, Safety, Environment and Quality unit.

  • No reference to “owner” is present in the CGMPs; yet the guidance states that 21 CFR 200.10(b) and 21 CFR 211.22(a)) hold the Owner’s Quality Unit ultimately responsible for approving and rejecting drug product manufactured by the contract manufacturer.” 21 CFR 200.10(b) statement, “…as well as the person who is responsible for the failure to comply, shall be subject to regulatory action.” has applied to the Quality unit of the facility, not the new term and definition of “owner”.2.

  • The joint discourse analysis of the documents and conversations reveals the justification for the passage of the 1996 Illegal Immigration Reform and Immigrant Responsibility Act that built barriers in the same era that proposed an opening of markets and a coveted Free Trade Agreement of the Americas (FTAA).

  • Written release and rejection procedures should be available for products, and in particular for the release for sale of the finished product by the Quality unit.


More Definitions of Quality Unit

Quality Unit means any person orpersons designated with the authority and responsibility for overall quality management and other responsibilities as defined in § 213.22.
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Quality Unit means an organizational unit independent of production which fulfils both Quality Assurance and quality control responsibilities. This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.
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Quality Unit means collectively the Supplier Quality Assurance, Quality Control and Regulatory Affairs Departments.
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Related to Quality Unit

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

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

  • Quality factor (Q) means the modifying factor, listed in Tables I and II of 38.4(4), that is used to derive dose equivalent from absorbed dose.

  • 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”).

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • 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.

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

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • The Specification means the Specification annexed to or issued with G.T.C.C. and shall include the schedules & drawings attached thereto as well as all samples and pattern, if any.

  • Quality Standards means the quality standards published by BSI British Standards, the National Standards Body of the United Kingdom, the International Organisation for Standardisation or other reputable or equivalent body, (and their successor bodies) that a skilled and experienced operator in the same type of industry or business sector as the Contractor would reasonably and ordinarily be expected to comply with, and as may be further detailed in the Specification.

  • Service Specification means and include detailed description, statements to technical data, performance characteristics, and standards (Indian as well as) as applicable and as specified in the Contract as well as those specifications relating to Industry standards and codes applicable to the performance of the work, work performance quality and the specifications affecting the works or any additional specification required to be produced by the DCO to meet the design criteria.

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

  • technical specification means, with respect to any Software, the document setting forth the technical specifications for such Software and included in the Statement of Work.

  • Contract Specifications means the principal trading terms in CFD (for example Spread, Swaps, Lot Size, Initial Margin, Necessary Margin, Hedged Margin, the minimum level for placing Stop Loss, Take Profit and Limit Orders, financing charges, charges etc) for each type of CFD as determined by the Company from time to time.

  • Statement of Work means the description of activities performed in completing the Project, as specified in the Contract and as may be amended.

  • Unit Price Work means the Work, or a portion of the Work, paid for based on incremental units of measurement.

  • Quality Management System means a set of interrelated or interacting elements that organisations use to direct and control how quality policies are implemented and quality objectives are achieved;

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • 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;

  • The Equipment/Product means all the Air conditioners along with the accessories which the Vendor is required to supply to the Bank under the Contract.

  • High Quality Waters means all state waters, except:

  • QAP shall have the meaning set forth in Clause 11.2;

  • Quantity means either tonnage or volume, depending on which term is the standard in the mining industry for the type of mineral;

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • The Equipment/Product means all the hardware, it’s all components, associated software/firmware/operating software which the Vendor is required to supply to the Bank under the Contract.