Tag Archives: risk

  • 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 …

  • 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 …

  • Leachables and Extractables in Biopharmaceutical Processing

    … With all this activity going on its often helpful to solicit the help of a consultant that is aware of the issue s to help guide a path forward. In developing protein therapeutics that may be sensitive to contact with rubber and plastic components, the potential effect of Leachables over time can become a critical processing consideration. To help to address this issue, part of the modern approach is to use risk Assessment and risk Mitigation strategies to first quantify the extent of the …

  • Reaching into Research and Development of a Supply Chain Strategy

    … selection of raw materials and components and their suppliers early in the development cycle. The strategy should be based on risk management principles and the needs and demands of the commercial market. The strategy would consider the unique attributes of the material and suppliers balanced against the potential risks that may be encountered when manufacturing for the commercial market. To read the full white paper, click on the following link: Reaching into Research and Development for …

  • Change Management; A Vital Part of the Lean Mechanism within the Life Sciences Industry.

    … incorporated with enthusiasm, then it is unlikely that a sustained return on investment will be achieved. Due to cultural, regional, age, educational and gender differences, new ideas and information will be received, processed and incorporated at different rates, so an analysis of what you have at your site should be a key part of any approach before systems are rolled out. This stakeholder analysis should be part of any risk Analysis and mitigation plan that is performed prior to deployment …

  • Risk Management as part of your Lean Compliance Strategy to enable you to meet your Compliance Obligations.

    In a regulated industry like the Life Sciences Industry which covers Pharmaceutical, Biologics, Biotechnology Drugs, Medical Devices, Medical Device/Drug Combination Products, Diagnostics and Tissue Therapies, adherence to strict regulatory& quality compliance  principles is a given. However, over killing what you are doing can be very costly and may be forcing cuts in other vital areas of the commercial operation. That’s why using risk Assessment Techniques to develop a Lean Compliance …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    … from that stance, and toward a quality-by-design approach – an approach that meshes well with the waste reduction, and continual improvement objectives of lean manufacturing. However, the pharmaceutical industry has been slow to take to both the PAT initiative, as well as lean manufacturing solutions, basically for the same reasons. The main obstacle, and probably the hardest to overcome, has to do with cultural issues and mindset. A deeply entrenched attitude of risk aversion in the …

  • Behind The Increasing Need for Pharmaceutical Consultants

    … still remaining competitive. One of the three main drivers in the push toward outsourcing is, of course, FDA regulations. A few of the major developments in the last few years are: August 2002: The FDA set in motion a new initiative entitled the Pharmaceutical Current Good Manufacturing Practices (cGMP) for the 21st Century: A risk-Based Approach. This initiative focuses on the risks to public health that could result from flaws in manufacturing procedures. The stated purpose is to ensure that …

  • FDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake

    … finished. This letter may show one of three scenarios: -It may simply recognize that the inspection was done and that nothing significant was found. -It may list deficiencies found during the inspection, but may point out that no response is necessary.  Nevertheless, it is important that the site acts on these deficiencies in view of future inspections. -It may point out serious negative discoveries.  The site and the data are at risk here, and you must answer immediately to clarify what steps …

  • Diabetes Trends Until 2025

    … performance will probably shape the market 2013-2014, and in the long run, until 2025. -After the new FDA guidelines were released in December 2008, pharma companies that work on diabetes drugs have had to perform more thorough studies to prevent ‘unacceptable’ cardiovascular risk.  They have to perform meta analyses for cardiovascular safety during Phase II and III trials, and must discard the chance of an increased cardiovascular disease risk by 80% or more.  What this means is …