ISPEInternational Society for Pharmaceutical Engineering

The ISPE Baseline® Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification (C&Q) of pharmaceutical manufacturing facilities, systems, utilities, and equipment to demonstrate that they are suitable for the intended purpose.


Quality Metrics InitiativeISPEInternational Society

Quality Metrics Initiative; Quality Metrics Initiative. ISPE has been in the forefront of the quality metrics dialog by hosting FDA and industry forums and workshops, conducting the industrys first Quality Metrics Pilot Program, and providing input to the FDA draft Guidances


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ISPE, ILF Engage with U.S. and Asian Regulators at

ISPE continued its mission to provide a neutral ground for pharmaceutical industry professionals and regulators to discuss industry issues at ISPE Affiliate meetings in Japan and China last month. The events brought together officials from FDA USA, PIC/S, PMDA, MHRA, Chinas State Food and Drug Administration (SFDA), and other agencies to discuss top industry concerns with key pharmaceutical


ISPE to Release Quality Metrics DataPowder/Bulk Solids

Mar 02, 2015· International Society for Pharmaceutical Engineering (ISPE), in conjunction with McKinsey & Co., will release preliminary data and findings from its Quality Metrics Pilot Program at the ISPE Quality Metrics Summit on April 2122 in Baltimore. Responding to FDAs call for quality metrics, the Summit will be an effective vehicle for communication between Industry and FDA.


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A Global Technology Roadmap for Biopharmaceutical

A Global Technology Roadmap for Biopharmaceutical Manufacturing: An Update from BPOG Philip McDuff (Biogen) Presentation to ISPE Facility of the Future Meeting 2016. Connecting Pharmaceutical Knowledge ispe.org


Pharmadule brings Chinese manufacturing insights to ISPE

Sep 25, 2014· Pharmadule brings Chinese manufacturing insights to ISPE Annual Meeting 2014Press ReleasePharmadule Morimatsu ABSEPTEMBER 25, 2014Nacka, Stockholm: Swedish-based designer and builder of modular production facilities for the life sciences industries, Pharmadule Morimatsu AB


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About ISPE 2014. ISPE, the International Society for Pharmaceutical Engineering, is the worlds largest not-for-profit association in this arena, committed to the advancement of the educational and technical efficiency of its members through creating forums for the exchange of ideas and practical experience.


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The 2009 ASHRAE Handbook: Fundamentals covers basic principles and data used in the HVAC&R industry. Updated with research sponsored by ASHRAE and others, this volume includes 1,000 pages and 39 chapters covering general engineering information, basic materials, climate data, load and energy calculations, duct and pipe design, and sustainability, plus reference tables for abbreviations and

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