GMP Standards definition

GMP Standards means the good manufacturing practice standards, designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product;
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GMP Standards means the Colombian good manufacturing standards for pharmaceutical laboratories in accordance with the guidelines set out in Decree 549 of 2001 and INVIMA Resolution 01087 of 2001;
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GMP Standards means the Good Manufacturing Practice regulations determined by the U.S Food and Drugs Association as shall be updated from time to time and applied by the Supervisor of GMP.
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Examples of GMP Standards in a sentence

  • Centogene shall ensure through its Third Party subcontractor at its own expense, that the Facility and all equipment required for the manufacture of Contract DBS Test Kits are in a state of repair and operating efficiency consistent with the requirements of GMP, Standards and Applicable Laws.

  • NNE Pharmaplan shall design and engineer this facility, incorporating the latest GMP Standards and best practices.

  • As most investments will be made in the Base Currency hedging will be required in respect of the investments attributable to the Dollar Shares.

  • We have not appointed any external agency and/or any technical expert to assess the demand for the products we propose to manufacture at our new facility at JB SEZ at Panoli, Gujarat complying with EU- GMP Standards.

  • For each API manufacturing/ intermediate manufacturing site listed above,→ Please attach a copy of the GMP certificate(s) and/or valid inspection report(s) from the last inspection demonstrating compliance of the API manufacturer with international GMP Standards for Pharmaceutical Products.

  • The products will be elaborated utilizing stringent quality assurance and quality control measures as required by GMP Standards.

  • Specialized Skill and Knowledge The nature of the Company’s business requires specialized knowledge and technical skill around cannabis cultivation and processing in Colombia, clinical sciences, product formulation, quality assurance, GMP Standards and GEP Standards, ingredient sourcing, and marketing and distributing of medicinal and wellness products, as well as clinic management.

  • The Active Pharmaceutical Ingredients (API) used in the vitamin A soft gelatin capsules must be manufactured and handled according to GMP Standards for Pharmaceutical Products, as certified by an internationally recognized authority that is a member of or partner to the Pharmaceutical Inspection Cooperation Scheme (PIC/S)7.

  • Once completed, the Research Technology and Processing Centre must be certified by INVIMA in order to ensure that it meets GMP Standards.

  • All of our production lines: tablets, capsules, dry powder, liquid injectables, solid oral solution Cephalosporins (specifically designated), are in full compliance with the Year 2011 GMP Standards.


More Definitions of GMP Standards

GMP Standards shall have the meaning accorded to it in Paragraph 3.2 hereof.
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GMP Standards means the FDA’s standards for good manufacturing practices set forth at 21 CRF Parts 210 and 211.
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Related to GMP Standards

  • PCI Standards means the applicable Data Security Standards published by the PCI Security Standards Council.

  • 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).

  • 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.

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

  • NERC Reliability Standards means the most recent version of those reliability standards applicable to the Generating Facility, or to the Generator Owner or the Generator Operator with respect to the Generating Facility, that are adopted by the NERC and approved by the applicable regulatory authorities, which are available at xxxx://xxx.xxxx.xxx/files/Reliability_Standards_Complete_Set.pdf, or any successor thereto.

  • Technical Standards means the technical standards set out in paragraph 2.4 of the Order Form;

  • National Standards means the document entitled “National Standards for the Volatile Organic Compound Content of Canadian Commercial/Industrial Surface Coating Products Automotive Refinishing, October 1998, PN 1288" and published by the Canadian Council of Ministers of the Environment;

  • Standards means the British or international standards, Authority's internal policies and procedures, Government codes of practice and guidance referred to in Framework Schedule 13 (Standards) together with any other specified policies or procedures identified in Framework Schedule 13 (Standards);

  • Applicable Standards means the requirements and guidelines of NERC, the Applicable Regional Entity, and the Control Area in which the Customer Facility is electrically located; the PJM Manuals; and Applicable Technical Requirements and Standards.

  • auditing standards means auditing standards as defined in National Instrument 52-107 Acceptable Accounting Principles and Auditing Standards;

  • Minimum Standards means standards of practice that interpret the legal definition of nursing as well as provide criteria against which violations of the law can be determined.

  • Codes and Standards means all the applicable codes and standards as indicated in the Technical Specification.

  • Service Level Standards has the meaning ascribed thereto in Section 2.1 hereof.

  • 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.

  • 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;

  • Standards Board means the Professional Standards Board established pursuant to 14 Del.C. §1201.

  • Design Standards means the standards developed as a requirement of the Programmatic Agreement

  • 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.).

  • State minimum standards means minimum requirements

  • Pretreatment standards means any standards of performance or other requirements imposed by

  • Service Standards means the set of Service Measures, Service Levels, conditions and Service Guarantee Payments as set out in Schedule 1;

  • Security Standards means the final rule implementing HIPAA’s Security Standards for the Protection of Electronic PHI, as amended.

  • Privacy Standards means the standards of the privacy of individually identifiable health information, as pursuant to HIPAA.

  • Air Standards Manager means the Manager, Human Toxicology and Air Standards Section, Standards Development Branch, or any other person who represents and carries out the duties of the Manager, Human Toxicology and Air Standards Section, Standards Development Branch, as those duties relate to the conditions of this Certificate.

  • 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.

  • harmonised standard means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;