GMP

GMP. All requirements imposed on a licensed manufacturer and distributor of cosmetics in Japan under the Pharmaceutical Affairs Law (Law No. 145 of 1960) and related regulations, including, without limitation, (i) Article 13 of the Pharmacy, Etc. Structure and Facilities Regulations (providing standards for the structure and facilities of places of manufacture of ordinary cosmetics), (ii) Chapter III of the Ministerial Ordinance Concerning Quality Control Standards for Pharmaceuticals,... Quasi-Pharmaceuticals, Cosmetics and Medical Equipment, (iii) Article 3 of the Ministerial Ordinance Concerning Post-Manufacture / Sale Safety Control Standards for Pharmaceuticals, Quasi-Pharmaceuticals, Cosmetics and Medical Equipment, (iv) the "Negative / Positive List" of Cosmetics Standards under Ministry of Health Labor & Welfare Notification No. 331 of September 29, 2000, and (v) labeling standards concerning the ingredients and shelf life of cosmetics as contained in Ministry of Health Labor & Welfare Notification No. 332 of September 29, 2000 and Ministry of Health Labor & Welfare Notification No. 66 of September 26, 1980, as the same may be amended or re-enacted from time to time. Wellness' operational quality standards are defined in internal GMP documents. View More

GMP. Means the current good manufacturing practices as specified in the quality system regulations at 21 CFR Part 820 or similar regulatory laws of any applicable Regulatory Authority, as such regulatory laws are in effect at the time of design and/or manufacturing.

GMP. Means the current good manufacturing practices for bulk excipients as set forth in: (i) 21 C.F.R. parts 210 and 211 of the U.S. Code of Federal Regulations; (ii) the International Conference on Harmonization (ICH) Guide Q7; and (iii) U.S. Pharmacopoeia <1078>; as of the Effective Date or as may be amended or re-enacted from time to time and as interpreted in accordance with then-current industry standards and FDA policies.

GMP. Those practices in the manufacture of pharmaceutical products that are recognized as the current good manufacturing practices by the FDA in accordance with FDA regulations, guidelines, and other administrative interpretations and rulings in connection therewith, including, but not limited to those regulations cited in 21 C.F.R. Parts 210 and 211 and the current International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guidance for... Industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. View More

GMP. Good Manufacturing Practice means the part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use.

GMP. Good manufacturing practices as required under the rules of the applicable Governmental Authority in the Territory

GMP. Means current good manufacturing practices as defined by the FDA.

GMP. Good manufacturing practices as applicable for the Services in each jurisdiction in the Territory.

GMP. Means current Good Manufacturing Practice; which are requirements for the quality system under which Products will be manufactured. Those practices are laid down in guidelines and regulations including ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients and US Code of Federal Regulations 21CFR parts 210 & 211.

GMP. Means requirements for the quality system under which drug products and their ingredients are manufactured under conditions of current good manufacturing practices for bulk excipients as pursuant to the Federal Food, Drug, and Cosmetic Act and consistent with regulatory guidance, standards or directives, as applicable and as set forth in U.S. Pharmacopeia <1078> as of the Effective Date or any successor thereto.