Quality Systems and GMP Requirements definition

Quality Systems and GMP Requirements means the current and any future quality system and good manufacturing practices regulations under 21 C.F.R. Part 820 to the extent that such regulations are applicable to the Product, as such regulations are promulgated by the FDA. The applicable Quality Systems and GMP Requirements for any lot of Product shall be those regulations in effect when such lot is manufactured for NeoGenomics.
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Quality Systems and GMP Requirements means the current and any future quality system and good manufacturing practices regulations under 21 C.F.R. Part 820 to the extent that such regulations are applicable to a Celera Product, as such regulations are promulgated by the FDA. The applicable Quality Systems and GMP Requirements for any lot of Celera Product will be those regulations in effect when such lot is manufactured by Celera for AMI.
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Examples of Quality Systems and GMP Requirements in a sentence

  • Abbott will maintain a quality system to ensure that the Products are manufactured in accordance with: (a) applicable Quality Systems and GMP Requirements; and (b) all pertinent rules and regulations of the FDA, as the same may be amended from time to time.

  • Abbott shall manufacture the Products in accordance with: (a) the Specifications; (b) applicable Quality Systems and GMP Requirements; and (c) all pertinent rules and regulations of the FDA, as the same may be amended from time to time.

  • ABI shall manufacture the Product in accordance with all applicable laws and regulations, including, without limitation, the Quality Systems and GMP Requirements.

  • MDS shall manufacture, or cause to manufacture, the MDS Products in accordance with (i) the applicable MDS Quality Systems and GMP Requirements, (ii) all pertinent rules, requirements and regulations from FDA, as the same may be amended from time to time, and (iii) the Product Specifications.

  • BioPad shall manufacture the Licensed Products in accordance with all applicable laws and regulations, including, without limitation, the Quality Systems and GMP Requirements.

  • Celera will manufacture Celera Products in accordance with: (a) the applicable Quality Systems and GMP Requirements; (b) all pertinent rules and regulations of the FDA, as the same may be amended from time to time (but only to the extent that the Celera Products are subject to FDA regulations); and (c) any equivalent foreign requirements and regulations, as applicable.

Related to Quality Systems and GMP Requirements

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

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

  • Quality Standards means the quality standards published by BSI British Standards, the National Standards Body of the United Kingdom, the International Organisation for Standardization 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 Schedule.

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

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

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

  • 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 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 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.

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

  • 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.

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

  • 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;

  • Reliability Standards means the criteria, standards, rules and requirements relating to reliability established by a Standards Authority.

  • Program Requirements means that Partner has to fulfill certain program requirements as described in detail in the applicable SAP PartnerEdge Model and the PartnerEdge Program Guide.

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

  • Specifications and Standards means the specifications and standards relating to the quality, quantity, capacity and other requirements for the Project Highway, as set forth in Schedule-D, and any modifications thereof, or additions thereto, as included in the design and engineering for the Project Highway submitted by the Contractor to, and expressly approved by, the Authority;

  • 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).

  • Regulatory Requirements means all applicable laws, rules, regulations, orders, requirements, guidelines, interpretations, directives and requests (whether or not having the force of law) from and of, and plans, memoranda and agreements with, any Regulatory Authority.

  • Product Specifications means those product, labeling and performance specifications for the Product filed with and approved by the relevant Regulatory Authority, including Product formulae, labeling, and materials required for the manufacture of the Product that is to be purchased and supplied under this Agreement, as such are set forth on Schedule 1.25, which specifications may be amended by the Parties from time to time in accordance with this Agreement.

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

  • Specifications means the Specifications of the Works included in the Contract and any modification or addition made or approved by the Project Manager.