cGMP

cGMP. All then-current applicable laws, regulations and recognized good manufacturing practices that apply to the manufacture of any therapeutically active material that provides pharmacological activity in a pharmaceutical product, and govern the standards of manufacture of any product intended for human use, including, as applicable: (i) the United States regulations set forth under 21 CFR parts 210, 211, as well as applicable guidance published by the FDA; and (ii) the EU good manufacturing... practices set forth in the European Community directives 2003/94/EC 2001/83/EC as amended by 2004/27/EC, all relevant implementations of such directives and all relevant principles and guidelines including ICH Tripartite Guidance Q7 and Volume 4 of the Rules Governing Medicinal Products in the European Union: Medicinal Products for Human and Veterinary Use; in each case as may be modified or supplemented during the Term. View More

cGMP. Means the current good manufacturing practice regulations promulgated, administered and enforced by the FDA as set forth in 21 C.F.R. Part 820 or other similar and applicable regulatory requirements applicable to the manufacture and supply of a Product.

cGMP. The current good manufacturing practices applicable to the Manufacture of Product pursuant to Applicable Law, including but not limited to the Current Good Manufacturing Practice Regulations of the United States Code of Federal Regulations 21 CFR Parts 210 and 211 and the European Community Directive 2003/94/EC (Principles and Guidelines of Good Manufacturing Practice for Medicinal Products), as well as the applicable documents developed by the International Conference on Harmonization (ICH),... in effect as of the date of Manufacture of a particular Batch of Product. View More

cGMP. Means the current Good Manufacturing Practice standards in effect in the United States at the date on which the Primary Bank of the Cell Line (26 Nov. 2008) and the Seed Cell Bank (11 Sep 2017) were produced.

cGMP. Refers to current good manufacturing practice requirements to the extent applicable to a supplier of a Medical Component, as promulgated by the regulatory authority, including, without limitation, the Federal Food, Drug and Cosmetic Act and 21 C.F.R. Part 820; and in the future, as applicable, Canadian Medical Devices Conformity Assessment System to the extent necessary for Product to be distributed in Canada; Medical Device Directive MDD 93/42 EEC/AIMDD 90/385/EEC (Directive 2007/47/EC)

cGMP. Means the current good manufacturing practices, including the regulations promulgated by the FDA under the U.S. Federal Food, Drug, and Cosmetic Act, 21 C.F.R. Part 820, as amended from time to time

cGMP. Means the principles detailed in the United States Current Good Manufacturing Practices (21 C.F.R. §§200, 211 and 600).

cGMP. Current good manufacturing practices as established by the FDA, or Regulatory Authorities in European Union or Japan, relating to the manufacture of medicinal products for human use, including, without limitation, current good manufacturing practices as specified in the ICH guidelines, including without limitation, ICH Q7, Guidance on Good Manufacturing Practices of the International Conference on Harmonization of Technical Requirements of Pharmaceuticals for Human Use and the Guide to Good... Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC. View More

cGMP. Means "current Good Manufacturing Practices" or "CGMP" as promulgated under U.S. Food, Drug & Cosmetics Act (21 U.S.C. §301 et seq.) and the regulations thereunder including 21 Code of Regulations chapters 210 and 211, as amended from time to time. If Cytovance agrees to manufacture Client Product in accordance with EMA regulations, then "CGMP" also includes "Good Manufacturing Practices" or "EU GMP" as specified in the EU Guidelines to Good Manufacturing Practices: Medicinal Products for Human... or Veterinary Use, as amended from time to time. View More

cGMP. Means those practices in the manufacture of pharmaceutical products that are recognized as current good manufacturing practice regulations and guidelines as described and promulgated by Regulatory Authorities including (i) the FDA in accordance with FDA regulations guidelines and other administrative interpretations, and, without limitation, (ii) the then-current International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q7 Good... Manufacturing Practice Guidance for Active Pharmaceutical Ingredients as adopted by the relevant Regulatory Authority in the subject jurisdiction, and (iii) The European Union's Eudralex Volume 4, Part II (independent of the Annexes) where it is in direct agreement with ICH Q7, all as updated, amended, and revised from time to time. View More