483 Reports Posts

Leadership’s Role in Improving Supplier Quality Management in Life Sciences

Leadership’s Role in Improving Supplier Quality Management in Life Sciences

Matthew Littlefield, President and Principal Analyst, LNS Research

The demands on quality organizations are rising across the board, but perhaps none as quickly or urgently as in the life sciences industries. While increased competition and the need to innovate certainly aren’t unique circumstances for life sciences, the level of scrutiny from regulatory agencies and the rapidly evolving nature of the supplier network are, placing an incredible burden on elevating supplier quality management capabilities. (more…)

Clinical Trials Guidance: Q&A with Patrick Stone

Mark Crawford

Patrick Stone is president and lead consultant for TradeStone QA LLC in Austin, Texas (www.tradestoneqa.com). A strong advocate for human subject protection, his specialties include bioresearch monitoring in human clinical and pre-clinical trials. The following interview focuses on the FDA and clinical trials. (more…)

Managing CAPA Requires a Strong SOP

Mark Crawford

According to Nancy Singer and Mark Lagunowich in their informative MD+DI article entitled “Getting Your CAPA House in Order,” CAPA (Corrective and Preventative Action) remains one of the top FDA 483 citations year after year, due typically to “either inadequate processes or inconsistent adherence to processes,” they write. “This includes failing to define which issues should or should not be elevated to CAPA status, insufficiently documenting the data required by FDA to adequately assess the CAPA’s effectiveness, or relying on outmoded systems to collect and analyze the data and demonstrate that the firm is operating in a state of control.” (more…)

483s Can Be a Good Thing (Really)

Mark Crawford

According to FDANews, the increasing rate of FDA inspections and warning letters is continuing this year—as of June 2011 the FDA had issued 874 letters in fiscal 2011, compared with 673 last year. If FY 2011 is like 2010, leading issues will be quality unit deficiencies, inadequate batch failure investigations, lack of follow-up procedures, validation of manufacturing processes, and handling deviations. For international inspections, deficient laboratory controls, quality unit deficiencies, and deficient procedures led the list last year. (more…)