Good Manufacturing Practice Requirements definition

Good Manufacturing Practice Requirements means the applicable requirements set forth in the quality systems regulations for drugs contained in 21 C.F.R. Parts 210, 211, 600 and 610 and comparable standards of other applicable Governmental Body.
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Good Manufacturing Practice Requirements means the requirements set forth in the quality systems regulations for drugs contained in 21 C.F.R. Parts 210, 211, 600 and 610 and comparable standards of other applicable Governmental Entity.
Sample 1Sample 2Sample 3
Good Manufacturing Practice Requirements means the FDA’s standards for manufacturing drugs and biological products, including those standards contained in
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Examples of Good Manufacturing Practice Requirements in a sentence

  • For more information regarding cGMP requirements for combination products please refer to the FDA Guidance titled Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products issued in January 2017 (https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM429304.pdf).

  • See the FDA Guidance for Industry and Staff: Current Good Manufacturing Practice Requirements for Combination Products for more information at https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM429304.pdf.

  • Current Good Manufacturing Practice Requirements for Combination Products5.

  • Where applicable, reference is made to sections of the “Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products” for additional information (Ref.

  • Combination products under 21 CFR Part 3 are subject to 21 CFR Part 4 “Current Good Manufacturing Practice Requirements for Combination Products” which is accessible at https://www.federalregister.gov/articles/2013/01/22/2013-01068/current- good-manufacturing-practice-requirements-for-combination-products.

  • Device CommentsRegarding manufacturing practice: 21 CFR Part 4 - Current Good Manufacturing Practice Requirements for combination products, we agree with your plan to conduct device performance testing in accordance with 21 CFR 820.30 (briefing document page 20 of 60) and your plan to complete Human Factor (HF) formative and HF validation studies and use the final single-dose applicator design in the Phase 3 study and the definitive PK study (briefing document page 24 of 60).

  • Also refer to guidance for industry and FDA staff Current Good Manufacturing Practice Requirements for Combination Products.

  • The Company’s products are manufactured by contracted production facilities that are subject to many regulations, including Food Facility Registration, recordkeeping, Good Manufacturing Practice Requirements, reporting, preventive controls and inspections.

  • Combination product manufacturing Please note that Part 3 combination products are subject to 21 CFR Part 4 Current Good Manufacturing Practice Requirements for Combination Products4.

  • Pt. 4 Subpart B [Reserved]PART 4—REGULATION OF COMBINATION PRODUCTS21 CFR Ch. I (4–1–21 Edition)rent good manufacturing practice oper- ating system at facilities that manu- facture co-packaged or single-entity combination products.Subpart A—Current Good Manufacturing Practice Requirements for Combina- tion ProductsSec.

Related to Good Manufacturing Practice Requirements

  • Good Manufacturing Practices or “GMP” means, with respect to the United States, the minimum then-current good manufacturing practices for methods, facilities, and controls to be used for the manufacture, processing, packing, or holding of a drug to assure that it meets the requirements of the Federal Food, Drug, and Cosmetic Act for safety and has the identity and strength and meets the quality and purity characteristics, specified in 21 C.F.R. Parts 210 and 211, as may be amended, and, with respect to any other country or jurisdiction, the equivalent regulations in such other country or jurisdiction.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.

  • 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.

  • cGMPs means, as applicable, current good manufacturing practices as described in:

  • Good Laboratory Practices or “GLP” means the regulations set forth in 21 C.F.R. Part 58 and the requirements expressed or implied thereunder imposed by the FDA and (as applicable) any equivalent or similar standards in jurisdictions outside the United States.

  • Applicable Technical Requirements and Standards means those certain technical requirements and standards applicable to interconnections of generation and/or transmission facilities with the facilities of an Interconnected Transmission Owner or, as the case may be and to the extent applicable, of an Electric Distributor, as published by Transmission Provider in a PJM Manual provided, however, that, with respect to any generation facilities with maximum generating capacity of 2 MW or less (synchronous) or 5 MW or less (inverter-based) for which the Interconnection Customer executes a Construction Service Agreement or Interconnection Service Agreement on or after March 19, 2005, “Applicable Technical Requirements and Standards” shall refer to the “PJM Small Generator Interconnection Applicable Technical Requirements and Standards.” All Applicable Technical Requirements and Standards shall be publicly available through postings on Transmission Provider’s internet website.

  • Good Laboratory Practice or “GLP” means the applicable then-current standards for laboratory activities for pharmaceuticals (including biologicals) or vaccines, as applicable, as set forth in the Act and any regulations or guidance documents promulgated thereunder, as amended from time to time, together with any similar standards of good laboratory practice as are required by any Regulatory Authority having jurisdiction over the applicable activity.

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Good Engineering Practice means, Works carried out in accordance with the following standards/ specifications,

  • Good Clinical Practices means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials contained in 21 C.F.R. Part 50, 54, 56, 312, 314, 320, 812, and 814 and (ii) “Good Laboratory Practices” means the FDA’s standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58.

  • 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.

  • GMPs means all good manufacturing practices under Title 21 of the United States Code of Federal Regulations, as amended from time to time.

  • Good Clinical Practice or “GCP” means the then current standards for clinical trials for pharmaceuticals, as set forth in the ICH guidelines and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good clinical practice as are required by the European Union and other organizations and governmental agencies in countries in which a Licensed Product is intended to be sold to the extent such standards are not less stringent than the ICH guidelines.

  • Manufacturing Process means any process for—

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Good Industry Practices means the practices that would be adopted by, and the exercise of that degree of care, skill, diligence, prudence and foresight that reasonably would be expected from, a competent contractor in the international oil and gas industry experienced in performing work similar in nature, size, scope and complexity to the Work and under conditions comparable to those applicable to the Work, where such work is subject to, and such contractor is seeking to comply with, the standards and codes specified in the Contract or (to the extent that they are not so specified) such national or international standards and codes as are most applicable in the circumstances, and the applicable Law.

  • Good Industry Practice means standards, practices, methods and procedures conforming to the Law and the degree of skill and care, diligence, prudence and foresight which would reasonably and ordinarily be expected from a skilled and experienced person or body engaged in a similar type of undertaking under the same or similar circumstances.

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

  • 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.

  • 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;

  • Product Specification means the document referred to in:

  • Regulatory Requirement means any law, regulation or court order, or any rule, direction, guideline, code, notice or restriction (whether or not having the force of law) issued by any regulatory authority, governmental agency (including tax authority), clearing or settlement bank or exchange, or industry or self-regulatory body, whether in or outside Hong Kong, to which HKICL, we or any other Participant or the respective affiliates or group companies, or you are subject or are expected to comply with 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.

  • Technical Specifications A specification in a document defining the characteristics of a product or a service, such as the quality levels, the environmental and climate performance levels, the design for all needs, including accessibility for people with disabilities, and the evaluation of conformity, of product performance, of the use of the product, safety or dimensions, as well as requirements applicable to the product as regards the name by which it is sold, terminology, symbols, testing and test methods, packaging, marking or labelling, instructions for use, the production processes and methods at every stage in the life cycle of the supply or service, as well as the evaluation and conformity procedures;

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.