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CHANGE CONTROL FOR FDA REGULATED INDUSTRIES: A RISK ASSESMENT APPROACH David N. Muchemu
Publisher: Authorhouse

Oct 29, 2011 - Proactive identification of potential risks resulting out of non-compliance to good manufacturing practices (GMP) is a challenge to the industry and therefore production plants require continuous assessment of the activities through stringent audits, according to SM Mudda, It recommends a quality system based and risk-based approach for regulation of pharmaceutical cGMP. In 2002, the FDA announced its initiative for the 21st century, which introduced the concept of Risk Management and Quality by Design. Such a Yet in contrast to the systematic risk assessment strategies used by experts, most members of the public rely instead on mental short cuts to quickly and efficiently make sense of the many decisions they face in a uncertain world. Apr 17, 2013 - It must operate within the legal, regulatory and policy framework of FDA as it now exists; use a systematic approach for life cycle benefit risk assessment; and decide on a new approach. The assessment would take “We are moving away from our 'one-size-fits-all' approach to clinical trial outcomes for these devices,” FDA officials wrote. Jul 1, 2013 - We contend that precautionary regulation should provide an incentive to generate better data and recommend adopting a pragmatic, but scientifically better founded approach to mixture risk assessment. Risk Management Procedures; Evidence & Uncertainties in the known data; Conclusions & Reasons for Decision. FDA currently regulates medical devices as one thing with one risk assessment, be it an embedded system medical device like a blood gas analyzer or a system made up of many components like a patient monitoring Only a legislative change will enable FDA to mandate the reporting of “near misses. Jun 10, 2011 - And to cap it all, the US Food and Drug Administration released Draft Guidance for Industry on Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology. Adequacy of the safety database, the severity and reversibility of AEs, and the potential for sub-optimal management in the post-market setting. The International Application of the risk assessment should also be consistent over the project to achieve the benefits of the ASTM E2500 approach. The Registration, Evaluation, Authorisation and Restriction of Chemicals (EC 1907/2006) (REACH) in June 2007, a number of extensive reviews of the literature concerning uncertainty factors were published by government agencies and industry associations [1-5]. Dec 13, 2013 - Agency officials late last year proposed a benefit-risk assessment that they say would provide a more consistent pathway to approval. Sep 30, 2013 - The workgroup recommends that HIT be regulated based on whether the use of the products represent any risk to patients or users (a risk-based approach). Jan 25, 2012 - This approach led to redundancy in documentation and testing, and caused delays in project schedules from changes made in the process to meet quality expectations. Dec 10, 2013 - In this regard then, understanding the social, cultural and psychological factors that influence how individuals perceive the risks of genetically modified food can inform more pragmatic and effective approaches to policy. This is where the US FDA adopted ICH Q9 Quality Risk Management in June 2006.