Tag Archives: efficiency

  • Lean Biomanufacturing: Keeping Your Eye on the Quality Goal

    … going to hurt our companies and the industry as well. Lean manufacturing in medical products, which should include but need not necessarily be limited to pharmaceuticals, vaccines, biotechnology products and medical devices is all about producing the highest quality products for consumers. As already noted, this is frequently missed out when one talks about Lean because out culture is often heavily geared towards the efficiency component. This is naturally understandable in a highly competitive …

  • Lean Product Change–Over in an FDA Regulated Environment

    … compliance functions, where as Lean requires similarly strict adherence to operating modalities that assure efficiency, repeatability and overall process capability. Where much of the conflict appears to reside is in relation to how that execution is achieved. However, with the advent of recent new guidance documents which include GMPs for 21st century, ICH Q8, Q9 & Q10, we’re seeing a more pragmatic approach to compliance that is more systematic and which lends itself to fit naturally …

  • Poka-Yoke as a Mechanism to Assure Reliable Production of Pharmaceuticals and Other Life Science Products.

    Reliable performance is a must in any industry but no more so than connected with the production of Life Science Products such as pharmaceuticals and medical devices. Poka-Yoke, the Japanese term used in Lean operations refers to the process of mistake proofing or providing a fail safe mechanism that will assure reliable operation. Eliminating defects or preventing operational mistakes can have a major effect on process capability, product specifications and operational efficiency, just to …

  • 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 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

    … now being fully felt.  Quality product development, however, depends on input from manufacturing.  Therefore, in accordance with lean manufacturing’s emphasis on seamless, unified production processes, ongoing two-way communication between manufacturing and the lab must be present. Industry analysts and lean manufacturing consultants suggest that, as a first step, effectiveness should be emphasized over efficiency. However, because the larger cost savings result from efficiency-driven …

  • 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 …

  • Pharmaceutical Consulting Firms: Hero or Hype?

    … conducting a thorough analysis of the claims process, the firm will then be armed with the information they need to suggest and assist in implementing changes in the process that will result in improved efficiency and noticeable cost savings. A consulting firm can also discover practicable ways to automate, or even outsource, portions of the billing process. Pharmaceutical consulting, although relatively new, is proving to be just what the doctor ordered along the entire spectrum of companies …

  • Transforming the Traditional Approach with Lean Manufacturing Techniques

    … along with eliminating waste, improving efficiency, creating customer value, and striving for continuous improvement, also aims to change culture. One of the main things lean manufacturing techniques can accomplish is the elimination, or at least reduction, of waste. For pharmaceutical manufacturer’s, waste most often comes in the form of excess inventory and waiting – both of which are primarily due to long lead times resulting from the historical batch orientation, as well as …

  • Innovative R&D Through Lean Manufacturing Principles

    … instead of batch testing of compounds, which decreases testing time, thus allowing faster feedback, and reduced time and effort Simplification of the management review process, resulting in greater efficiency Setting up regular reviews of screening cascades, thus improving decision-making and the ability to jettison weak information models early in the process Exploration of methods to reduce lead-in time Information and communication aspects can be improved in these ways: Ensuring an …

  • The Drive Behind Lean Manufacturing Implementation

    … the rise. In 2005, the FDA fined GlaxoSmithKline $650 million due to irregularities at a production facility in Puerto Rico. · Fewer block-buster drugs are being produced. Consequently, it’s increasingly difficult to justify the burgeoning costs of drug development and to gain investors for future development. With all these hurdles reducing profitability, pharmaceutical executives are now actively seeking to remodel production and boost efficiency. The first issue to receive consideration …