cGMP

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

cGMP. Means those laws and regulations applicable in the U.S. and Europe, 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 Q7A 'ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients', US Federal Food Drug and Cosmetic Act at 21CFR (Chapters 210, 211, 600 and 610) and the Guide to Good Manufacturing Practices for Medicinal... Products as promulgated under European Directive 91/356/EEC. For the avoidance of doubt, Lonza's operational quality standards are defined in internal cGMP policy documents. View More

cGMP. Those current Good Manufacturing Practices required by the FDA to be followed in connection with the manufacture, handling, storage and control of pharmaceutical products in the United States, as set forth in the Act and any regulations related thereto