Good Manufacturing Practice Requirements definition

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.
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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 detailed information on combination products please see guidance for industry Current Good Manufacturing Practice Requirements for Combination Products (January 2017).3• All facilities used for storing or warehousing drug substance, in-process material, and commercial drug product under quarantine prior to a disposition decision, including any facilities that solely store the stability samples.

  • The representative of the European Union reiterated concerns about Korea's Good Manufacturing Practice Requirements for Cosmetics (KCGMP).

  • You should also identify whether facilities follow the combination product streamlined manufacturing approach (as described in FDA’s Guidance for Industry and FDA Staff: “Current Good Manufacturing Practice Requirements for Combination Products” (Ref.

  • Subpart A—Current Good Manufacturing Practice Requirements for Combina- tion Products§ 3.9 Effect of letter of designation.(a) The letter of designation con- stitutes an agency determination that is subject to change only as provided in paragraph (b) of this section.(b) The product jurisdiction officer may change the designated agency component with the written consent of the sponsor, or without its consent to protect the public health or for other compelling reasons.

  • Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products, January 2017.

  • 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.

  • See guidance for industry and FDA staff Current Good Manufacturing Practice Requirements for Combination Products and compliance program 7356.000 Inspections of CDER-Led or CDRH-Led Combination Products.14 See https://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf.

  • E9–22992 Filed 9–21–09; 11:15 am]BILLING CODE 3410–02–PCurrent Good Manufacturing Practice Requirements for Combination ProductsAGENCY: Food and Drug Administration, HHS.ACTION: Proposed rule.SUMMARY: The Food and Drug Administration (FDA or agency) proposes to codify the current good manufacturing practice (cGMP) requirements applicable to combination products.

  • For further information on 21 CFR Part 4, see Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products (Jan.

  • 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).

Related to Good Manufacturing Practice Requirements

  • Good Manufacturing Practices or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise.

  • 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 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.

  • cGMPs means current good manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations, together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;

  • Good Laboratory Practices or “GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA, as defined in U.S. 21 C.F.R. Part 58 (or such other comparable regulatory standards in jurisdictions outside the United States, as they may be updated from time to time).

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

  • 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 federal and state statutes, regulations, regulatory guidance, judicial or administrative rulings, requirements of Governmental Contracts and standards and requirements of any accrediting or certifying organization, including, but not limited to, the requirements set forth in a Product Attachment.

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

  • 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.