Voices: PAT Answers
The FDA’s PAT initiative, in combination with Quality by Design (QbD), encourages the pharmaceutical industry to intensify its focus on efficiency in manufacturing. Conventional production relies heavily on off-line testing of both in-process materials and the end products. The FDA seeks to modernize practice by promoting a shift towards knowledge-based design and development, and the use of analytical tools that can continuously monitor critical processes. For some variables, timely and/or continuous measurements in the operational environment remain a significant technical hurdle, but for others, proven solutions are already commercially available. Particle size is one such variable.Read More
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- Dec 6, 2006Critical to any PAT effort is having a single point of easy, on-demand access to all relevant data, in a context thats meaningful to diverse groups of users. But data must be presented in a way that facilitates the identification and understanding of cause-and-effect relationships. Justin Neway, CSO and EVP of Aegis Analytics, talks about the issues and what they mean for PAT-related IT.
- Aug 25, 2006Isolation and too narrow a focus limits possibilities for your career and life, your organization, and the industry. Sure, you may be doing your job right, but are you doing the right job?
- Jul 27, 2006Although PAT and technologies like NIR are important, there still are things that they cannot do, concedes NIR expert Emil Ciurczak. Are advocates within the industry suspending rational and much needed skepticism, he asks, when they talk about eliminating final product stability testing altogether?
- Jul 6, 2006cGMPS are essential, but when cGMP dogma triumphs over common sense and prevents innovation, were all in trouble, says NIR expert and pharmaceutical industry consultant Emil Ciurczak. He offers some tips for drawing the line between compliance and absurdity.
- Jun 27, 2006NIR expert Emil Ciurczak thinks prosperity and the Internet are making today's graduates far too complacent and out of touch for their own good. Networking and professional societies are at risk, he says, and drug manufacturing will be worse off for it.
- Jun 1, 2006NIR expert Emil Ciurczak asks whether PAT will eliminate the need for traditional USP product release tests and concludes that theyre still essential as a reference method, and important in minimizing liability.
- Apr 27, 2006Excel, with its rounding errors, is a prime example of software written without the input of science-types.
- Mar 24, 2006PAT and analytical services dont always mix, as PAT columnist Emil Ciurczak relates. His advice: Dont allow your PAT group to become a stepchild. Ensure that it receives credit for PAT-based improvements.
- Mar 1, 2006A successful industry means job security for both FDA and instrument vendors. They are on your side; talk with them. Dont rely on word of mouth to make decisions about PAT.
- Jan 24, 2006Attention, corporate bean counters: PAT is not a magic bullet for reducing QC headcounts. In fact, it may require hiring more people, but the efforts will pay off in improved efficiencies and lower costs.
- Dec 20, 2005Dont be penny-wise but pound-foolish during early planning and budgeting stages, and never base decisions on equipment sticker prices without considering savings in time to market.
- Nov 22, 2005A consultant ponders the question, as it relates to NIR and pharmaceutical PAT projects that require a high level of hard-to-find technical expertise.
- Oct 27, 2005Last year at the IFPAC conference, NIR guru Emil Ciurczak bemoaned the fact that PAT was being promoted by geeks for geeks. Now, however, he notes that an upcoming summit may lead the charge toward a new emphasis on convincing corporate and financial managers that PAT simply makes good business sense.
- Jul 28, 2005A common user interface, and out of the box software will be essential to driving PAT in the pharmaceutical industry, say Pfizers control and IT experts Velumani Pillai and Martin Warman. Theyre developing a template for IT requirements and seek input from vendors and other users.
- Jun 22, 2005API manufacturers in India and China have grasped the need for simplicity, while U.S. process chemists continue along their costly and complex path. Girish Malhotra shares recommendations for improved API process development.
- Jun 1, 2005Not only data mining but metadata must be considered closely, by a cross-functional team representing all users of that data.
- Apr 29, 2005It’s not too soon to get involved in a new Engineering Research Center proposed by Rutgers, Purdue, NJIT and the University of Puerto Rico (Mayaguez). In this article, Rutgers University’s Holly Crawford and Fernando J. Muzzio describe the effort and how corporate involvement early on will help. A meeting is scheduled for May.
- Apr 29, 2005April’s Induniv conference in San Juan and Interphex in New York City focused on PAT to an unprecedented degree.
- Mar 31, 2005In his plenary speech at IFPAC 2005, FDA's Ajaz Hussain mapped out a "proactive journey" to pharmaceutical quality, based on PAT, science of design, and quality systems. Begin your journey now.
- Mar 31, 2005Weak FDA support and a dearth of adequate sensor technology are holding back adoption of PAT in biopharmaceutical manufacturing, says Xcellerex President Galliher.
- Mar 31, 2005FDA’s involvement has convinced pharma to embrace PAT, but new recruitment and validation issues have arisen as PAT moves into its next phase.
- Feb 24, 2005A pioneer offers his perspectives on PAT and where it’s heading and reminisces about his 23+ years leading Eli Lilly’s process analytics program. His advice: Remember that PAT won’t magically lead to headcount reduction; it isn’t always easy to do, and you can (and should) start small! Before starting a new position as North American manager of process analytics with the chromatography vendor Dionex, he shared his views with Editor in Chief Agnes Shanley.
- Jan 27, 2005Human error is something that drug manufacturers can no longer ignore, as a recent drug recall shows.
- Jan 26, 2005New worlds demand a new approach to measurement and data collection.
- Dec 28, 2004Advocates need to communicate the benefits of PAT more forcefully to senior management.
- Dec 23, 2004The industry needs to understand its manufacturing processes if it is to transform them and better serve its ultimate consumer, the patient, asserts G.K. Raju, CEO of Light Pharma, Inc.