ICH Q7A definition

ICH Q7A has the meaning set forth in Section 5.2.
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ICH Q7A means the good manufacturing practice guidance for active pharmaceutical ingredients developed under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
Sample 1

Examples of ICH Q7A in a sentence

  • FDA and ICH guidelines provide that a sponsor seeking a license is considered the “manufacturer” even if they use a contract manufacturing organization, and the sponsor is responsible for ensuring GMP compliance for those activities that have been contracted out (US FDA 21 CFR 600.3(t), ICH Q7A Section 2).

  • This audit will include a review of PDL’s PQ Plans and Reports, and their overall Quality Management System, using the standards set forth in ICH Q7A and the US and EMEA Regulations.

  • The API supplier selection, certification and verification of GMP compliance (ICH Q7A) are the responsibility of CUSTOMER.

  • Shasun shall assure that all systems used to manufacture, test, release, and distribute the Product shall comply with ICH Q7A section 12 Validation, as well as additional in-house requirements.

  • Also for the purposes of this SQA cGMP relates to the published International Conference on Harmonization (ICH) Q7A and consensus draft texts and guidelines agreed to by the appropriate ICH Expert Working group and agreed to as applicable by both parties.

  • All manufacture and supply of API will be performed in accordance with current Good Manufacturing Practices and the International Conference on Harmonization (ICH) Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.

  • RSM warrants that (i) such Improved GOS was manufactured by RSM in strict compliance with CGMP and with Section 19 of Guidelines ICH Q7A, Specifications, and the terms and conditions of this CSCA; and (ii) RSM has received from RXXXXX payment in full of USD 35,000 (thirty-five thousand) for such Improved GOS.

  • In performance of this Agreement, each party shall comply with all laws, regulations, rules, orders and other requirements and guidelines (e.g., record retention provisions of ICH Q7A guidelines), now or hereafter in effect, and governmental authorities having jurisdiction.

  • Throughout the Term, and for so long thereafter as is required by Applicable Law, each Party shall monitor and maintain reasonable records respecting its compliance with GMP for Finished Product (in the case of MIOL) and ICH Q7A (in the case of Oscient), including through the establishment and implementation of such operating procedures as are reasonably necessary to assure such compliance.

  • This quality agreement, (written in accordance with the principles defined in Section 16 of the ICH Q7A Guideline “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”), specifies the relationship between NTP Radioisotopes (Pty) Ltd., Pelindaba, Pretoria, South Africa and Lantheus Medical Imaging Company, 000 Xxxxxx Xxxx Xx., Xxxxx Xxxxxxxxx, XX 00000 XXX for the final materials, listed in Appendix A.

Related to ICH Q7A

  • ICH means the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

  • ICH GCP means the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) together with such other good clinical practice requirements as are specified in Directive 2001/20/EC of the European Parliament and the Council of 4 April 2001 relating to medicinal products for human use and in guidance published by the European Commission pursuant to such Directive.

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • cGCP means the then current Good Clinical Practices that establish the international ethical and scientific quality standards for designing, conducting, recording and reporting clinical trials that are promulgated or endorsed for the United States by the FDA (including through ICH E6 and 21 CFR Parts 50, 54, 56 and 312) and for outside the United States by comparable Governmental Authorities.

  • GLP means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable foreign regulatory standards.

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

  • Licensed clinical social worker means an individual who meets the licensed clinical social worker requirements established in KRS 335.100.

  • cGLP means current good laboratory practice standards as defined by the FDA pursuant to 21 CFR Part 58 (or in the case of foreign jurisdictions, comparable regulatory standards), and in any successor regulation or any official guidance documents issued by a Regulatory Authority.

  • 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.

  • FFDCA means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Benchmarks Regulation means Regulation (EU) 2016/1011 of the European Parliament and of the Council of 8 June 2016 on indices used as benchmarks in financial instruments and financial contracts or to measure the performance of investment funds and amending Directives 2008/48/EC and 2014/17/EU and Regulation (EU) No 596/2014;

  • 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.

  • Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;

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

  • NOAA means National Oceanic and Atmospheric Administration or successor thereto.

  • HCPCS means CMS' Healthcare Common Procedure Coding System, which describes products, supplies, procedures and health professional services and includes, the American Medical Associations (AMA's) Physician "Current Procedural Terminology", Fourth Edition (CPT-4) codes, alphanumeric codes, and related modifiers.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following: