GMP

GMP. As relevant to the Products, the principles and guidelines of good manufacturing practice as contained (a) with respect to any Product intended for use or sale in the European Union, in either directive 91/356/EEC (medicinal products for human use) or directive 91/412/EEC (medicinal products for veterinary use), as such principles and guidelines are interpreted and expanded in "The Rules Governing Medicinal Products in the European Community, Volume IV. Good Manufacturing Practice for medicinal... Products" and/or amended from time to time, and any reasonably equivalent successors to such guidelines and principles or (b) with respect to Product intended for use or sale in any other portion of the Territory, any equivalent guidelines or regulations. View More

GMP. Means material that (a) has been manufactured under conditions of current good manufacturing practices for bulk excipients as set forth in U.S. Pharmacopoeia <1078> as of the Effective Date or any successor thereto.

GMP. The current Good Manufacturing Practice regulations and the Quality System Regulations promulgated by the FDA, including 21 C.F.R. Part 820 et seq., as such regulations may be amended from time to time, and such equivalent regulations or standards of countries outside the United States as may be applicable to activities conducted hereunder.

GMP. Good Manufacturing Practice as defined in the Code of Federal Regulations Chapter 21, parts 210 and 211 pertaining to API manufacturing, and as currently practiced in the pharmaceutical industry.

GMP. The applicable current good manufacturing practices promulgated from time to time by the FDA in accordance with the Act, including those set forth in 21 C.F.R. Parts 210 and 211, and consistent with ICH guidelines

GMP. Good Manufacturing Practices promulgated by the FDA and set forth in Title 21 Subchapter B - Food for Human Consumption Parts 110, 129 and 165

GMP. The part of quality assurance which ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use, as reflected in the pharmaceutical and medical device industry standards for the European Union and the FDA in the USA and the similar guidelines of any other recognized national regulatory body applicable to the Territory, as amended from time to time in force at the relevant time during the term of this Agreement

GMP. Those current Good Manufacturing Practices as reflected in the pharmaceutical and medical device industry standards for the FDA in the United States, inclusive of the Quality Systems Regulation (QSR), 21 CFR part 820, and similar guidelines of any other recognized national regulatory body applicable to the Territory, as amended from time to time during the Term of this Agreement

GMP. The regulatory requirements for current good manufacturing practices promulgated by the FDA under the U.S. Food, Drug, and Cosmetic Act and the regulations promulgated thereunder, particularly 21 C.F.R. Section 210 et seq., and 21 C.F.R. Sections 600-610, as the same may be amended from time to time

GMP. Current Good Manufacturing Practices as promulgated by the FDA.