Search results
Results from the WOW.Com Content Network
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 BFS process functions similarly to conventional extrusion blow molding, and takes place within a BFS machine. [6] First, a plastic polymer resin is heated to >160 °C and compressed to 35 MPa, [11] [15] allowing it to be extruded in tubular form, [1] and be taken over by an open two-part [16] mold to form the container.
Equipment used in aseptic processing of food and beverages must be sterilized before processing and remain sterile during processing. [1] When designing aseptic processing equipment there are six basic requirements to consider: the equipment must have the capability of being cleaned thoroughly, it must be able to be sterilized with steam, chemicals, or high-temperature water, sterilization ...
Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down into a series of unit operations , such as milling , granulation , coating , tablet pressing , and others.
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]
Sterile pre-filled medications Nephron states that is has more than 20 years of sterile pharmaceutical manufacturing experience and produces those products from an outsourcing facility.
"Water for Pharmaceutical Use". Inspection Technical Guides. U.S. Food and Drug Administration. 27 August 2014. "Guideline on the quality of water for pharmaceutical use (draft)" (PDF). 4 Committee for Medicinal Products for Human Use (CHMP). European Medicines Agency (EMA). 13 November 2018. "Water for injection". Drug Information Portal. U.S ...
Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process.CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes.