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Last updated on April 24, 2014 at 6:16 EDT

Latest Quality by Design Stories

2013-02-05 08:34:37

SHANGHAI, Feb. 5, 2013 /PRNewswire/ -- Quality by Design China 2013, organized by CPhI Conferences, will be held on 17th - 18th April in Shanghai, China. (Photo: http://www.prnasia.com/sa/2013/02/05/20130205070152184029.html ) Due to the proposing of the drug quality documents from FDA and ICH, Quality by Design has been the consensus of the pharmaceutical industry. With the rapid development of export to the US and EU, each company has the strong demand to deeply understand the QbD...

2013-01-31 12:27:53

RESEARCH TRIANGLE PARK, North Carolina, January 31, 2013 /PRNewswire/ -- KEMWELL BIOPHARMA PVT LTD, a global pharmaceutical contract development and manufacturing company, announced today that its Oral Solids manufacturing facility located in Bangalore, India has successfully completed a U.S. Food and Drug Administration (USFDA) inspection. The cGMP Audit for a Pre-Approval Inspection (PAI) was triggered by a NDA filing by one of the top ten global pharmaceutical companies. This...

2013-01-22 23:00:55

Former FDA official co-authored agency's Process Analytical Technology Guidance King of Prussia, PA (PRWEB) January 22, 2013 Tunnell Consulting, Inc. today announced that it has formed a partnership with Ali Afnan, PhD, President of Step Change Pharma, a life sciences consultancy working at the intersection of regulatory compliance and pharmaceutical science. An expert in compliance and quality, Dr. Afnan was recruited in 2003 by the FDA´s Center for Drug Evaluation and Research...

2012-10-23 15:28:16

SAN DIEGO, Oct. 23, 2012 /PRNewswire/ -- Accelrys, Inc. (NASDAQ: ACCL), a leading provider of scientific innovation lifecycle management software, today announced that it has acquired Aegis Analytical Corp. (Aegis) for $30 million in cash, expanding Accelrys' portfolio with enterprise manufacturing process intelligence capabilities that provide organizations with unmatched insights into their product lifecycle processes. The addition of Aegis' industry-leading software to the...

2012-09-19 02:31:27

WEST POINT, Pa., Sept. 19, 2012 /PRNewswire/ -- Colorcon, Inc., (http://www.colorcon.com) a world leader in the development and supply of formulated coatings and other excipients for the pharmaceutical and nutritional supplement industries, announces customer access to valuable expertise in film coating formulation and process applications to assist pharmaceutical manufacturers with their Quality by Design (QbD) initiatives. Starting in January 2013, the FDA expects drug manufacturers to...

2012-07-03 23:02:41

New Guide helps companies meet CGMP requirements and avoid product adulteration, product mix-up, label mix-up and misbranding. Tampa, Fla. USA (PRWEB) July 03, 2012 ISPE announced today that it has released new guidance relating to the design, construction and commissioning and qualification of packaging, labeling and warehousing (PACLAW) facilities. The Guide helps companies meet CGMP requirements for these types of facilities while avoiding product adulteration, product mix-up, label...

2012-07-01 22:20:48

OSLO, Norway, July 2, 2012 /PRNewswire/ -- CAMO Software, leaders in multivariate data analysis software, and up to data professional services GmbH, a leader in regulatory study reporting software solutions, have partnered to deliver an industry-first solution for Quality by Design initiatives in the life science industry. CAMO's Unscrambler(R) X multivariate data analysis software will be seamlessly integrated with up to data's iStudyReporter solution for regulatory...

2012-02-15 01:00:00

LONDON, February 15, 2012 /PRNewswire/ -- Senior representatives from leading pharmaceutical companies including Roche Diagnostics, Lonza, Abbott, F. Hoffman-La-Roche LTD and Novartis MIT will meet at the Pharma Qbd Forum in Berlin, Germany on 24th-25th April 2012 to share their expert knowledge on how Quality by Design can be implemented in pharmaceutical development. One of the main points of discussion will be the findings of the Merck Serono case study and how the...

2011-08-22 07:00:00

The magazine and its websites capture regional and national awards for best use of social media and excellence in writing. Itasca, Illinois (PRWEB) August 22, 2011 Putman Media's Pharmaceutical Manufacturing has won one gold 2011 National award and two gold Midwest/South regional awards from the American Society of Business Publication Editors (ASBPE). These prestigious annual awards recognize the best in B2B magazine editorial, design and Web and digital content development strategy and...

2011-07-25 14:17:00

SILVER SPRING, Md., July 25, 2011 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of July 25, 2011. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations. Events and Speeches for the...