Quality System Requirements definition

Quality System Requirements means the quality requirements for Factories, as determined and amended from time to time by the Board, the version thereof in force as at the Signature Date being annexed hereto as Annexure “B”.
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Quality System Requirements means current Good Manufacturing Practices; the then-current good manufacturing practices and standards for the manufacture, testing, filling and/or preparation for delivery of drug substance pursuant to (a) the U.S. Federal Food, Drug and Cosmetics Act as amended (21 USC 301 et seq.), (b) relevant U.S. regulations found in Title 21 of the U.S. Code of Federal Regulations (including but not limited to Parts 11, 210, 211, and (c) the EC Guide to Good Manufacturing Practice for Medicinal Drug Products, including respective guidance documents and any comparable laws, rules or regulations of any of the above jurisdictions, as each may be amended from time to time. cGMP also includes adherence to any applicable product license requirements, to the current requirements of the United States [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. Pharmacopoeia/National Formulary, the current requirements of the European Pharmacopoeia and the relevant current International Conference on Harmonization (ICH) guidance documents, including without limitation the ICH Guidance Q7 Good Manufacturing Practices Guidance for Active Pharmaceutical Ingredients and including the Japanese Pharmaceutical Affairs Law (PAL) in the cGMP, all as applicable.
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Quality System Requirements means the requirements related to the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management for the manufacturing of medical devices, as set forth in 21 C.F.R. Part 820 and relevant international standards for quality management systems, including ISO 13485.
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Examples of Quality System Requirements in a sentence

  • Part 21 (Certification Procedure for Products and Parts) Suppliers of new FAA products/parts shall provide documented evidence of traceability to FAR Part 21, Quality System Requirements, with each shipment.

  • With respect to Canada's Trademarks Act, Bill C-86 amends the Act to add bad faith as a ground of opposition to the registration of a trademark and for the invalidation of a trademark registration.

  • The applicable Design Holder’s Quality System Requirements must be evaluated for applicable test report, approved process sources, first article inspection reports, to include frequency and format, or other specification requirements during contract review and prior to release for production.Additional Customer Proprietary CAGE Codes may exist beyond those listed in Table 1.

  • The Association for the Advancement of Medical Instrumentation (AAMI) GMP/ Quality System: Requirements and Industry Practice (or equivalent).

  • Each Party shall ensure that its Listed Inspection Service maintains a Quality System in compliance with the current PIC/S Quality System Requirements for Pharmaceutical Inspectorates.

  • The Supplier’s Quality Systems must comply with ISO 9001 Quality System Requirements or the supplier must show evidence of developing systems towards compliance.

  • Q15) UTAS Supplier Quality System Requirements ASQR-01 applies to this order.

  • In addition, Seller shall comply with all quality requirements and procedures specified by Buyer, as the same may be revised from time to time, including those applicable to Seller as set forth in Quality System Requirements QS-9000.

  • Suppliers of new FAA products/parts shall provide documented evidence of traceability to FAR Part 21, Quality System Requirements, with each shipment.

  • Accordingly, in 2014, Meritor published a new version of our Supplier Quality System Requirements (“SQSR”) manual which is incorporated by reference into our purchase orders and other agreements and which obligates our suppliers to exercise due diligence on the source and chain of custody of any Conflict Minerals incorporated in their products sold to Meritor and to report those findings to Meritor.


More Definitions of Quality System Requirements

Quality System Requirements. The Contractor shall provide and maintain a quality system that, as a minimum, adheres to the requirements of ANSI/ASQC Q9001-1994 Quality Systems-Model for Quality Assurance in Design/Development, Production, Installation, and Servicing and supplemental requirements imposed by this contract. The quality system procedures, planning, and all other documentation and data that comprise the quality system shall be made available to the Government for review. Existing quality documents that meet the requirements of this contract may continue to be used. The Government may perform any necessary inspections, verifications, and evaluations to ascertain conformance to requirements and the adequacy of the implementing procedures. The Contractor shall require of subcontractors a quality system achieving control of the quality of the services and/or supplies provided. The Government reserves the right to disapprove the quality system `* portions thereof when it fails to meet the contractual requirements. USE OF CONTRACTOR'S INSPECTION EQUIPMENT (NAVSEA) (MAY 1995) (5616)
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Quality System Requirements. Quality System Requirements includes those standard operating procedures ("SOP's") and other policies and procedures issued from time to time by Symphonix to enable compliance by Symphonix and Distributor with Regulatory Requirements, the Symphonix Quality System and with good business practices. "Regulatory Requirements" Regulatory Requirements include those laws, regulations, standards, guidelines that are applicable or become applicable during the Term of this Agreement to the distribution of the Products in the Territory as set forth on Exhibit D, which exhibit may be changed from time to time during the Term.
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Quality System Requirements means those system requirements for assuring quality set forth in Exhibit B.
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Related to Quality System Requirements

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

  • 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.

  • Program Requirements means certain minimum program entry requirements as well as ongoing program requirements, to be fulfilled by Partner, some of which are general PartnerEdge requirements, some of which are specific for the “Sell Engagement” and some of which are specific for the different “Cloud” Product Families, including, without limitation payment of the Program Fee(s), meeting certain minimum annual revenue requirements, upholding a Sell Authorization for at least one “Cloud” Product Family and other requirements as set out in detail in the PartnerEdge Program Guide and the RSPI.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Ambient air quality standard means an established concentration, exposure time, and frequency of occurrence of air contaminant(s) in the ambient air which shall not be exceeded.

  • 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 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;

  • Applicable water quality standards means all water quality standards to which a discharge is subject under the federal Clean Water Act and which has been (a) approved or permitted to remain in effect by the Administrator following submission to the Administrator pursuant to Section 303(a) of the Act, or (b) promulgated by the Director pursuant to Section 303(b) or 303(c) of the Act, and standards promulgated under (APCEC) Regulation No. 2, as amended.

  • Accessibility Standards means accessibility standards and specifications for Texas agency and institution of higher education websites and EIR set forth in 1 TAC Chapter 206 and/or Chapter 213.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Project Requirements means the statement included in the Request for Proposal detailing the technical and other requirements of Canada which are to be met by the successful Bidder, and which are to be addressed in the Bid;

  • Service Specifications means the following documents, as applicable to the Services under Your order:

  • Pretreatment requirements means any substantive or procedural requirement related to pretreatment, other than a pretreatment standard, imposed on an industrial user.

  • Minimum Requirements means the minimum requirements for available commercial structures. The minimum requirements may be found at this link: https://portlandgeneral.com/energy- choices/renewable-power/green-future-impact The minimum requirements may be updated from time to time to reflect PGE’s criteria from its latest Commission accepted renewable request for proposals.

  • Functional Specifications means the descriptions of features and functions of the Application as expressly set forth in Quote.

  • Safety Standards means all laws, union rules and trade or industry custom or codes of any kind whatsoever, in effect from the date of this Agreement through Final Acceptance of the construction work, pertaining to worker safety and accident prevention applicable to the Project and/or the construction work (including, but not limited to, rules, regulations and standards adopted pursuant to the Occupational Safety and Health Act of 1970, as amended from time to time).

  • Water quality standards means provisions of state or federal law which consist of a designated use or uses for the waters of the Commonwealth and water quality criteria for such waters based upon such uses. Water quality standards are to protect the public health or welfare, enhance the quality of water and serve the purposes of the State Water Control Law (§ 62.1-44.2 et seq. of the Code of Virginia) and the federal Clean Water Act (33 USC § 1251 et seq.).

  • 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.

  • PJM Region Reliability Requirement means, for purposes of the Base Residual Auction, the Forecast Pool Requirement multiplied by the Preliminary PJM Region Peak Load Forecast, less the sum of all Preliminary Unforced Capacity Obligations of FRR Entities in the PJM Region; and, for purposes of the Incremental Auctions, the Forecast Pool Requirement multiplied by the updated PJM Region Peak Load Forecast, less the sum of all updated Unforced Capacity Obligations of FRR Entities in the PJM Region.

  • 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.

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • Technical Requirements means the Technical Requirements in Section VII of the tendering documents.

  • Standard Specifications means a compilation in book form of specifica- tions approved for general application and repetitive use;

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • PDMA means the Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder from time to time.