cGMP

cGMP. The current Good Manufacturing Practices officially published and interpreted by EMA, FDA and other applicable Regulatory Authorities that may be in effect from time to time and are applicable to the Manufacture of the Compounds.

cGMP. Current Good Manufacturing Practice as set out in the United States 21 CFR 210 and 211, as amended from time to time, together with, as applicable, any analogous regulations, codes or guidelines having effect in any jurisdiction in the Territory in which Products are to be Manufactured and/or distributed

cGMP. Means current good manufacturing practices applicable to the Manufacture of Product promulgated by any Authority.

cGMP. Means those current practices, as amended from time to time, related to the manufacture of biopharmaceuticals and pharmaceuticals as set forth in the FDCA and such standards of good manufacturing practice as are required by the FDA or other Regulatory Authorities (as defined herein), as agreed in the Project Plan and as may be set forth in the United States Code of Federal Regulations (Title 21, Parts 210-211).

cGMP. Means all then-current applicable requirements and standards for the Manufacture of pharmaceutical products for human use and their components, including, as applicable: (i) the current Good Manufacturing Practices relevant for the United States, including section 501(a)(2)(B) of the FFDCA (21 U.S.C. § 351(a)(2)(B)), and U.S. Code of Federal Regulations Title 21 parts 210-211, 600 and 610; (ii) the current Good Manufacturing Practices relevant for the European Union, as defined by the European... Commission Directive 2017/1572 as regards the principles and guidelines of good manufacturing practice for medicinal products for human use supplementing Directive 2001/83/CE, as amended and the EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines, and any other guideline, law, or regulation applicable to the manufacture of medicinal products for human use. For clarity, this clause (ii) shall be applicable to any manufacturer in countries outside of the European Union with respect to the manufacturing of medicinal products intended to be placed on the market in the European Union; (iii) all Regulatory Approvals and applicable local laws at the site(s) of manufacture or testing, including GUI-001 Good Manufacturing Practices Guide for Drug Products (Canada) and Schedule M of The Drug Rules, Good Manufacturing Practices and Requirements of Premises, Plant, and Equipment for Pharmaceuticals Products (India); and(iv) with respect to active pharmaceutical ingredients, in addition (as applicable) the International Conference on Harmonization (ICH) current good manufacturing practices, as specified in ICH Q7, and all successor regulations and guidance documents thereto; View More

cGMP. Means current Good Manufacturing Practices to include the Quality System Regulation (QSR's) in the United States existing on the Effective Date, as promulgated by the FDA.

cGMP. Means current Good Manufacturing Practices and includes the Medical Device Quality Systems Regulations (QSR) as defined in 1.11 in the United States existing on the Effective Date, as promulgated by the FDA.

cGMP. Shall mean all applicable standards and Laws relating to manufacturing practices for products (including ingredients, intermediates, bulk and finished products) formulated by any Governmental Authority having jurisdiction in the form of Laws, regulations, guidelines, advisory opinions and compliance policy guides and current interpretations of the authority agency, as the same may be updated, supplemented or amended from time to time.

cGMP. Shall mean all the laws, regulations and standards relating to [ * ] Production, including but not limited to, the United States Food And Drug Administration (FDA) current Good Manufacturing Practices, as set forth in the Code Of Federal Regulations (CFR), and the EEC Good Manufacturing Guidelines, Volume IV as such Regulations and Guidelines may be revised from time to time, and any other applicable laws, guidelines and regulations. If there should be a conflict between the FDA and EEC... standards, the more stringent of the two shall apply. Aviron shall be responsible to advise PCI of cGMP and other Agency requirements which shall apply to [ * ] Production conducted hereunder. View More

cGMP. Means the current good manufacturing practices for drug substances as set forth in the U.S. Food, Drug, and Cosmetic Act and applicable regulations promulgated thereunder, as amended from time to time.