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The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the ...
The Basis for GMP", [2] Good manufacturing practice, along with good agricultural practice, good laboratory practice and good clinical practice, are overseen by regulatory agencies in the United Kingdom, United States, Canada, various European countries, China, India and other countries.
GmP, a category of mixed train in German-speaking countries; Gimpo International Airport (IATA code), Seoul, South Korea; Martin GMP, an American transport aircraft; Gaobeidian East railway station (telegraph code), China Railway; Hyundai Electric Global Modular Platform, a platform for electric cars
The Site Master file contains specific and factual GMP information about the production and control of pharmaceutical manufacturing operations carried out at the named site and any closely integrated operations at adjacent and nearby buildings. If only part of a pharmaceutical operation is carried out on the site, the site master file needs to ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Nippon (official, English), (日本) (official, Japanese), Nihon (alternate, more common reading of 日本 in Japanese), Yamato (大和) or Wa (倭) (historic, ancient Japan, derogatory), Ōyashima (大八洲) (meaning the country of eight great islands, historic), Cipangu/Zipangu or Gipangu (appeared in The Travels of Marco Polo in the 13th ...
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
Google Dictionary is an online dictionary service of Google that can be accessed with the "define" operator and other similar phrases [note 1] in Google Search. [2] It is also available in Google Translate and as a Google Chrome extension. The dictionary content is licensed from Oxford University Press's Oxford Languages. [3]