Tag Archives: lean implementation

  • Lean Product Change–Over in an FDA Regulated Environment

    Some would argue that there is a conflict between the idea of lean practices and a highly regulated quality compliant environment. However, upon closer analysis this is not necessarily the case. Both Lean and Compliance have very definite requirements to operate properly and it’s this discipline of implementation and execution that can bind both rather than separate them as “end-game” outcomes. Compliance requires systematic control of elements connected to and driving manufacturing …

  • Eliminating Pharmaceutical Manufacturing Chaos through Implementation of an Effective 5S Program

    … will require constant attention so that new working practices become habits which are automatic actions of human behavior.   Achieving successful 5S implementation like all of lean implementation will require significant commitments from senior management and the workforce to overcome the inevitable resistance that is naturally associated with significant change. Overcoming this resistance through cultural change will be the real challenge in implementing this Lean tool, but organizations …

  • Lean Philosophy and the Life Science Industry

    It’s generally accepted that standard Lean approaches have not been well implemented in the pharmaceutical industry.  We feel that this is largely  due to a lack of appreciation of the complexities of manufacturing according to cGMP which is a necessity to be in regulatory and quality compliance. Although many of the basic principles of a Lean philosophy can be applied to the highly regulated Life Science Industry, implementation is often more complex due to the very stringent requirements …

  • Lean Approaches in Bioprocessing to Help Minimize Variability in Production Yields

    It’s probably no surprise to many skilled practitioners that one of the major lean initiatives in bioprocessing is to improve throughput and reduce cycle time. Apparently this is all very obvious but it’s really surprising how many manufacturing operations fall down over this relatively simple concept. AND this applies equally to both clinical production as well as commercial manufacturing. Very often there are points of failure in processes that are associated with variability at both the …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    In 2003 the FDA announced the Process Analytical Technology (PAT) initiative to “encourage the voluntary development and implementation of innovative pharmaceutical manufacturing and quality assurance.” This initiative was designed to improve process efficiency of both manufacturing and regulatory phases, and is comprised of four components: data analysis, process analytical tools, process monitoring, and continuous feedback. The quality-by-design aspect of PAT will reduce cycle time thus …

  • Lean Manufacturing Solves Drug Recalls and Bad Press

    In 2009, drug recalls reached an unprecedented high of 1,748. These recalls are attributable, in large part, to outsourcing and indiscriminate cost cutting. Today, more recent drug recalls and the resulting bad press are forcing the pharmaceutical industry to shift their focus to the manufacturing aspect of the drug production process. This latest rash of drug recalls has also intensified both consumer and media backlash against the pharmaceutical industry. A few examples of the most recent …

  • Lean Manufacturing for the Competitive Edge

    Factors within the pharmaceutical industry have combined with economy-related issues to force pharmaceutical companies to seek new ways of maintaining or regaining their competitive edge.  Increasing globalization, scarcity of new blockbuster drugs, growing regulatory burdens, the failing we-are-different attitude, and a longstanding emphasis on R&D at the expense of production are all making it necessary for pharmaceutical manufacturers to strive for lower costs, increased efficiency and …

  • The Right Sequence for Lean Manufacturing Implementation

    For a pharmaceutical manufacturer, implementing lean manufacturing can be a fairly seamless and efficient process.  It can also be fraught with resistance, incorrect perceptions and end up only a partial implementation.  The negative perceptions and attitudes that impede a successful, effective implementation of lean manufacturing solutions generally start at the top, and is where lean manufacturing consultants can provide the most effective assistance and guidance. The manufacturing arena is …

  • The Continuing Journey of Lean Manufacturing in the Pharmaceutical Industry

    There is no doubt that lean manufacturing solutions do work, however, implementation is not a one shot deal – rather it is an ongoing process of continually striving for improvement. While there obviously has to be an emphasis placed on quality, once it is attained the focus must shift to sustaining quality through fostering a culture of continuous improvement. Toyota recently learned this lesson the hard way. The Toyota production system has been the touchstone for almost every lean …

  • Microbiology: Transcending Waste With Lean Manufacturing

      Today’s pharmaceutical industry is beginning to embrace the lean manufacturing process a little more enthusiastically than in previous years. Companies need, and want, to ensure operational excellence, improve quality, eliminate waste and non-value-added activities, become more responsive to customer demand, and improve efficiency—all of which lean manufacturing techniques can deliver. With the record 1,742 drug recalls in 2009, a much higher emphasis is being placed on quality …

  • Qualified Lean Manufacturing Consultants: Make or Break

    Toyota is generally credited with developing and articulating the basic principles and techniques of lean manufacturing back in the 1950s. Since then, companies in industries other than automotive have successfully implemented lean manufacturing and reaped the benefits of reduced waste, increased production efficiency, improved quality, and higher responsiveness to customer demand. For the most part, however, the pharmaceutical industry has lagged behind in this respect. Pharmaceutical …

  • Counteracting Expanding FDA Reporting Requirements Through Lean Manufacturing

    The pharmaceutical industry faces ever higher hurdles in the 21st century. With the recent rash of drug recalls – 2009 is the record year so far – one hurdle that is wreaking havoc with previous profit margins and just keeps growing is that of expanding regulatory compliance burdens and reporting requirements. And now the FDA appears to be raising the bar even higher with its proposed amendments to the Investigational New Drug Safety Reporting Requirements, which take effect 28 March …