Current Good Manufacturing Practices. Spectrum shall carry out its responsibilities hereunder, and shall use its Commercially Reasonable Efforts to cause the Third Party Manufacturers to carry out their responsibilities relating to the API, NPP Product and Bulk Product, in conformance with cGMPs, and any other Applicable Laws. In the event that Spectrum receives a formal regulatory notice or any other notice from a Regulatory Authority or Third Party manufacturer that identifies a material deficiency associated with the manufacturing process for the API, NPP Product or Bulk Product, or Spectrum itself or its Third Party manufacturers identifies such a material deficiency, Spectrum shall promptly advise Topotarget thereof and keep Topotarget apprised of Spectrum’s efforts to address the concerns of such Regulatory Authority as set forth in Section 11.1 of the Quality Agreement.
Current Good Manufacturing Practices. “GMP”) .
Current Good Manufacturing Practices. Regulations that set forth the minimum current good manufacturing practice for methods to be used in and the facilities or controls to be used for the manufacture, processing, packing, or holding of a drug to assure that the drug meets the requirements of the act as to safety, and has the identity and strength to meet the quality and purity characteristics that it purports or is represented to possess.
Current Good Manufacturing Practices. (cGMP). “cGMP” means those current good manufacturing practices and standards as promulgated by the FDA under the FFDCA in CFR 21 Part 11, 210, 211, and 820, as the same may be amended, revised, or supplemented in the future, for the control and manufacture of Product and equivalent regulations in jurisdictions for which Lifecore agrees in writing in accord with this Agreement to Manufacture Product.
Current Good Manufacturing Practices. The buildout of the Premises for Laboratory Use, the installation and maintenance of the laboratory equipment and facilities in the Premises, and the conduct of all aspects of Tenant’s Laboratory Use in the Premises shall at all times be undertaken and performed pursuant to procedures and requirements that satisfy and are consistent with the requirements of the federal Food and Drug Administration’s Current Good Manufacturing Practices in effect from time to time (“cGMP”). Tenant shall obtain and maintain in effect at all times throughout the Term of the Lease cGMP certification for its Laboratory Use, as applicable, as conducted by Tenant in the Premises.
Current Good Manufacturing Practices. To the extent applicable, all manufacturing operations relating to Company Products conducted by or on behalf of any Acquired Company have been and are being conducted in compliance with applicable provisions of current Good Manufacturing Practice requirements as set forth in 21 U.S.C. § 351(a)(2)(B), 21 C.F.R. Parts 210 and 211, and applicable FDA guidance documents. No Company Product has been recalled voluntarily or at the request of the FDA or any other Governmental Body.
Current Good Manufacturing Practices or the letters “GMP” or “cGMP” - shall mean current good manufacturing practice and standards as provided for (and as amended or updated from time to time) in (i) the Current Good Manufacturing Practice Regulations of CFR Title 21, including those regulations set forth in 21 CFR Parts 210 and 211, (ii) European Community Directive 2003/94/EC (Principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use), and (iii) all other applicable Regulatory Authority rules, regulations, policies and guidelines in effect at a given time and applicable ICH Harmonized Tripartite Guidelines.
