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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.
NEDU Class 100,000 clean room Operated by certified technicians, the Class 100,000 Clean Room performs a variety of cleaning and testing tasks: oxygen cleaning of piping, valves, regulators, tanks, and filters, as well as hydrostatic testing up to 10,000 psi (69,000 kPa).
The 200 and 300 series are regulations pertaining to pharmaceuticals : 202-203 Drug advertising and marketing; 210 et seq. cGMPs for pharmaceuticals; 310 et seq. Requirements for new drugs; 328 et seq. Specific requirements for over-the-counter (OTC) drugs. The 500 series are regulations for animal feeds and animal medications: 510 et seq. New ...
Pharmaceutical therapies [ edit ] The company's major franchises in the pharmaceuticals segment include immunology , neuroscience , infectious disease and vaccines, oncology , cardiovascular and metabolism , and pulmonary hypertension .
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.
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.
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).