Search results
Results from the WOW.Com Content Network
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages , [ 1 ] cosmetics , [ 2 ] pharmaceutical products , [ 3 ] dietary supplements , [ 4 ] and medical devices . [ 5 ]
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 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 drug manufacturer inspection by the US Food and Drug Administration. The pharmaceutical industry is a medical industry that discovers, develops, produces and markets pharmaceutical goods for use as drugs that are then administered to (or self-administered by) patients.
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 regulation of chemicals is the legislative intent of a variety of national laws or international initiatives such as agreements, strategies or conventions.These international initiatives define the policy of further regulations to be implemented locally as well as exposure or emission limits.
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]
The process chemistry group at Boehringer Ingelheim, for example, targets a VTO of less than 1 for any given synthetic step or chemical process. Additionally, the raw conversion cost of an API synthesis (in dollars per batch) can be calculated from the VTO, given the operating cost and usable capacity of a particular reactor.