Tag Archives: measure.

  • Risks in Lean Compliance

    What is Risk? Lean Biomanufacturing, Dr. Nigel J. Smart As the famous T. S. Eliot once said, “Only those who will risk going too far can possibly find out how far one can go.” This is most certainly the case in the science and pharmaceutical industry. We are in an industry that requires researchers to take the knowledge that they skillfully have acquired and run with it. This knowledge will not be of any use bottled up in one’s brain, unheard by others. Knowledge and the ability to take …

  • 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 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 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 …

  • Pharmaceutical Consultants Broaden the Scope

    It is a widely accepted fact that consultants assist companies by analyzing and assessing each individual situation and set of circumstances. Consultants then work with that company to design and implement appropriate programs, policies, and procedures based on those results. The final step is to advise, guide, and provide training in order to take the company from where they are now to where they need, and want to be. What’s far less well understood, however, is the value that …

  • 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 …

  • What You Need to Know About Vendor Audits

    A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.  The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.  This need for a closer monitoring of a vendor’s qualities and practices stems from an ever-evolving …

  • GMP Guidelines/Regulations in Stem Cell Research

    Good manufacturing practice or (GMP) is a common term for the control, management and manufacturing of quality control practices, applied to the pharmaceutical industry.  These common practice standards are specifically designed for pharmaceutical substances and products being made for clinical trials and production.  And one recent area of cGMP concern is over the newly emerging stem cell research industry.  How will stem cell research be affected by these ever tightening restrictions, and …

  • REMS Risk Management Strategies

    REMS is a recent and emerging regulatory requirement for all pharmaceutical companies, whereby the FDA expects these companies to monitor, submit plans, and proactively manage any and all safety risks in the sphere of their companies’ operations.  REMS stands for Risk Evaluation and Mitigation Strategy required for pharmaceutical and biotechnological companies.  Common REMS issues include drugs with abuse potential, risk of Qtc prolongation, drug-drug interactions, drugs with the risk of …

  • U.S. Falls Behind Europe in Research and Drug Development

    The U.S. has fallen behind Europe when it comes to drug research and development. A new study shows that European pharmaceutical companies outrank their U.S. counterparts when it comes to biotech, first-in-class and orphan products. Pharmaceutical consultants state that this evidence is a blow to the United States. While President Obama tackles the controversial health care reform debate, this study raises further awareness of the high cost of out-of-pocket medication expenses for U.S. …

  • Why Should Pharmaceutical Companies Develop Comprehensive Regulatory Training Programs?

    FDA and HPAA regulations are getting increasingly more complex, and their scope touches more than just the technical personnel in any given pharmaceutical company.  In order to succeed in today’s complex environment, EVERY employee needs to be aware and knowledgeable about these regulations and their implications for the company. In order to be able to sell products into other countries, workers must also be knowledgeable about the regulatory standards in those countries as well.  This can …