Tag Archives: concepts

  • Bottlenecking Theory

    Bottlenecking Theory Lean Biomanufacturing, by Dr. Nigel J. Smart Understanding this theory can help address key concepts that can help your research team yield optimal results. It’s important to begin your research by first running through some equations that will help your team throughout your experimental endeavors. After all, you wouldn’t read a book if you didn’t know its terminology first, right? It’s important to be well versed in the material that you are working on in order to …

  • Risks in Lean Compliance

    … identify potential risks before embarking on any sort of endeavor, especially something that involves time and money for your research team. By ranking and understanding the probability of various occurrences, based on a specific action or step in your process, you will have an overall better grasp on what could potentially cause issues down the line. If you’ve read SCG’s blog on waste removal, some of these concepts may not be unfamiliar to you. When identifying and understanding …

  • Kaizen Events

    Implementing Kaizen Events into Your Research Team’s Methodology Lean Biomanufacturing, Dr. Nigel J. Smart In lean biomanufacturing the term Kaizen events “refers to the impact of the outcome relative to the cost expended.” Much different than most constructive concepts, in a Kaizen event once the main event is complete, the researchers’ work is far from over.  In fact, their work has only just begun. These processes are quite complex and require strong attention to detail. A vital …

  • Lean Biomanufacturing: Keeping Your Eye on the Quality Goal

    … industry regulators. It is our thesis that it is not a conflict to be able to attain a Lean manufacturing process that meets efficient COGs and uses available resources effectively without sacrificing anything associated with product quality and safety. In fact, it’s out contention that through the appropriate application of Risk analysis advocated in many of the newer ICH documents, that the concepts of Quality by Design, will bring about both product quality/safety and process efficiency …

  • Qualified Lean Manufacturing Consultants: Make or Break

    … “While all of the classic tools of Lean Manufacturing can be applied to achieve benefits on a high-speed line, the application of Lean concepts must be translated to fit the production environment.” And there is the take-away for drug companies: “the application of Lean concepts must be translated to fit the production environment” peculiar to pharmaceutical manufacturing. Engineers at a juice-bottling company were “advised by Toyota experts to eliminate all of the …

  • The Lean Laboratory of the 21st Century

    The Lean manufacturing approach has worked for countless companies in the redesign of their business operations to minimize waste and cut costs through variations of process repetition.  Some might argue that these Lean manufacturing principles have been used most successfully in recent years by the pharmaceutical industry.  Basic Lean applications in the pharmaceutical industry up until this point have been focused on factory-based pharmaceutical manufacturing concepts and cost …

  • The 6 Crucial Principles in Pharmaceutical Leadership

    … strengths, and weaknesses of everyone in the group. –    Quick fixes.  In virtual teams it is easy to intensify minor problems because of the lack of human context, causing blockages in the process, thus, communication breakdowns must be solved fast. 5.    Build globally, adapt locally The global basis must be clearly defined, this is, the fundamental concepts that should have the same meaning no matter where you are, and the use of local examples and methods to help trainees find a …

  • The Pharmaceutical Industry Gets Six Sigma and Lean Manufacturing

    … supply, and launch of new products.  Timing is critical for the success of a new drug, thus, companies must reduce production timings to take full advantage of the market.  Lean manufacturing and Six Sigma offer value stream mapping and process modeling concepts capable of reducing these cycles and costs, making the processes and staff, more efficient. -Defects.  These are a huge risk for pharmaceutical companies.  No one wants to risk making people ill or to cause a death.  Lean’s …

  • Striving For A Change

    … and little by little, they improved their overall efficiency, reducing waste and controlling inventory. The concepts of Lean Manufacturing and Six Sigma approaches were critical, and soon the support of the FDA and other regulatory institutions was evident, as the new approaches sought to reduce risk by assessing quality from the beginning, and not relying on end-process testing. The FDA, did its part when it launched its own Process Analytical Technology (PAT) initiative, focusing on quality …

  • Risk analysis and Quality Systems in Development of LEAN Compliance Systems in Pharmaceutical Development and Manufacturing

    In an era of increased performance demands both by government bodies and the public in general, pharmaceutical companies must depend more than ever on sound quality control. Two concepts that merge in this modern environment are quality systems and risk analysis. The risks to be avoided are, more importantly, those to public health. Quality systems are a means by which to eliminate those risks within the manufacturing process. Namely, there are three areas of quality that are of interest when …

  • The Best Medicine For The Pharmaceutical Business

    … biopharmaceutical sector have become acquainted with more efficient ways of doing things, applying concepts such as “lean”, “lean manufacturing”, and “lean analysis” to both the development and production of new products as well as to their commercialization.  The main advantage is the optimization of the resources, starting with an important reduction in costs and waste (where all unnecessary materials or actions are deleted) and an increase in productivity. Here is a list of the …