Propofol Shortage Follows Teva and Hospira Warning Letters and Recalls
European manufacturer Fresnius is stepping in to help fill the US shortage in the injectible anaesthetic propofol caused by GMP problems at Teva and Hospira, resulting in warning letters and recalls. FDA's lengthy warning letter to TEVA in December, posted in April, focused on the manufacture of their generic version of propofol, and primarily related to microbial contamination and testing, including endotoxin in distributed product....
April 28, 2010 | Posted in GMP Deviations/Warning Letters, GMP Enforcement Activity, Recalls, The News in Depth, US/Canada | Read More »
MHRA is Requiring Interim Update Reports for Risk-Based Inspections
MHRA is requesting that all manufacturing sites inspected after April 1, 2009 under its risk-based inspection (RBI) approach submit interim updates to communicate significant changes between inspections....
April 26, 2010 | Posted in Agency Management, Europe, Inspection Initiatives, The News in Depth | Read More »
Coming Soon
Stay tuned for the next in-depth special report.
April 22, 2010 | Posted in Upcoming Issues | Read More »
Bill Paulson: Editor-in-Chief
Before launching IPQ, Bill served for over two decades as the primary author of “The Gold Sheet.” During his career tracking the drug and biotech quality regulatory process, Bill's identification of key issues and problem areas and emerging solutions has been influential in the targeting of resources by industry and FDA and has impacted the dialogue on the shaping of new CMC and GMP policies.
April 12, 2010 | Posted in Staff | Read More »
Jerry Chapman: CIO and Senior Editor
Jerry spent over three decades at Eli Lilly and Company in technical and leadership positions in product development, manufacturing, plant quality, site quality, corporate quality, and quality systems, retiring in December 2009 to join the IPQ team. At Lilly, Jerry designed and implemented for Lilly a comprehensive GMP Intelligence process to identify pertinent GMP regulations, inspection findings, trends, and best practices, and then analyze, communicate, manage, and archive that knowledge. Jerry is past Chair of the Midwest Discussion Group from 2007 until January 2010 and founder and Chair of the MWDG GMP Intelligence Subgroup, from April 2004 until January 2010.
April 6, 2010 | Posted in Staff | Read More »
Robert Morrow: CFO
Rob has 35 years of business, financial, marketing, and content publishing experience. He is founder and current CEO of eSchool Media Inc., an online content publisher in the education technology news and resource business and founder of eMedia Methods LLC an online content publishing business that provides research, training and educational services exclusively for the publishing industry.
April 1, 2010 | Posted in Staff | Read More »
