Mon premier blog

Good Design Practices for GMP Pharmaceutical Facilities Andrew Signore, Terry Jacobs
Publisher: Informa Healthcare

In 2005, Biolex undertook the expansion of its Good Manufacturing Practice (GMP) biomanufacturing facility in Pittsboro, North Carolina. Good Design Practices for GMP Pharmaceutical Facilities. FDA and other regulatory body requirements are discussed and the reasoning behind them. For MedImmune's new biopharmaceutical manufacturing facility in Frederick, Maryland, which won ISPE's Facility of the Year competition last year, best IT and automation practices not always seen in traditional pharma led to improved results. The facility, which opened in September 2004, needed to expand due to an Because of the use of an older building, the simplicity of the design and the use of modular systems for the processing equipment, the phase two expansion was in use and producing active pharmaceutical ingredients by the end of October 2005. These are general rules applicable to pharmaceutical manufacture, detailed in the Code of Federal Regulations. The use of clean steam is determined by the rules of Good Manufacturing Practice (GMP). This course explores some of the best practices of pharmaceutical facility design with an emphasis on the regulatory aspect. This article will look at They are also shrinking design-to-production timelines, which, Watler notes, have moved from 4-6 years a decade ago, to as little as 12 months and will soon shrink, for smaller facilities, to just six months. Good Design Practices for GMP Pharmaceutical Facilities … Jan 23, 2004 · Good Design Practices for GMP Pharmaceutical Facilities – Free ebook download as PDF File (.pdf), Text File (.txt) or read book online for free.