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 issued by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act.
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Examples of GMP Standards in a sentence

  • Figures obtained from the website of Adherents.com, last accessed 28 March 2003,http://www.adherents.com/largecom/com_hindu.html.

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

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

  • 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.

  • The CLIC–SR project started on 1 September 2012 and is being implemented in four countries in East Africa: Kenya, Uganda, Tanzania and Ethiopia.

  • The Company has revamped its Plant in accordance with Good Manufacturing Practice (GMP) Standards for pharmaceutical productions in past & got certification from State FDA, Haryana and continuously upgrading itto meet the international regulatory requirements.

  • Apart from documents specified in section 3.1, the driver who is loading goods, subject to HACCP and GMP Standards, should also have a valid medical record book for sanitary and epidemiological purposes.

  • The required packing standards and labeling must meet the latest requirement of the goods manufacturing practice (GMP Standards) in all respects and must follow Drug and Cosmetic Act 1940.

  • 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 purpose of this policy is to set out the requirements NIBTS is expected to meet to ensure compliance with the GMP Standards published in Eudralex volume 4.


More Definitions of GMP Standards

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

  • 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 2.5 of the Order Form;

  • Operating Standards shall have the meaning given such term in Section 2.1.

  • 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 all applicable Federal rules and regulations implementing Section 307 of the Act, as well as any nonconflicting State or local standards. In cases of conflicting standards or regulations, the more stringent thereof shall be applied.

  • 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;