Search results
Results from the WOW.Com Content Network
The USP Controlled Room Temperature is a series of United States Pharmacopeia guidelines for the storage of pharmaceuticals; [1] the relevant omnibus standard is USP 797. [2] [3] Although 100% compliance remains challenging for any given facility, [4] the larger protocol may be regarded as constituting a form of clean room [5] which is included in a suite of best practices.
A cleanroom or clean room is an engineered space that maintains a very low concentration of airborne particulates. It is well isolated, well controlled from contamination , and actively cleansed. Such rooms are commonly needed for scientific research and in industrial production for all nanoscale processes, such as semiconductor manufacturing.
This listing is limited to those independent companies and subsidiaries notable enough to have their own articles in Wikipedia. Both going concerns and defunct firms are included, as well as firms that were part of the pharmaceutical industry at some time in their existence, provided they were engaged in the production of human (as opposed to veterinary) therapeutics.
Requirements for materials used in the cleanroom [10] Maintaining the cleanroom environment in a clean, usable condition conforming to design standards. [10] This part was published as an International Standard in 2004. The document was submitted as an American National Standard and has been adopted as ANSI/IEST/ISO 14644-5:2004 in the United ...
The Hierarchy of Occupational Exposure Limits, of which occupational exposure banding is a member. Occupational exposure banding, also known as hazard banding, is a process intended to quickly and accurately assign chemicals into specific categories (bands), each corresponding to a range of exposure concentrations designed to protect worker health.
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 ...
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 ...
Pages in category "Pharmaceutical companies of the United States" The following 200 pages are in this category, out of approximately 211 total. This list may not reflect recent changes .