Tag Archives: Pharma industry

  • Flow Charting

    Getting to Know Flow Charting in Lean Biomanufacturing Lean Biomanufacturing, Dr. Nigel J. Smart When it comes to lean biomanufacturing, flow charting is deemed as one of the most basic techniques for defining what is required to operate a particular process. It is no question that the biopharmaceutical industry has evolved quite tremendously in recent years, and as we adapt to these changes, it’s vital to understand the progression in which the industry is transforming. The Pharma industry is …

  • Lean Biomanufacturing: Keeping Your Eye on the Quality Goal

    By Nigel J Smart PhD, Smart Consulting Group To some, Lean Manufacturing is a meaningless concept when one is considering medical therapies or medical products. Often there is confusion in common English language, where the emphasis is on the Lean & Mean interpretation associated with just being efficient. As we all know this is a big misconception associated with our terminology and unless we pay attention then there is a real danger that we will miss the boat and create something that’s …

  • Critical factors in Filing NDC numbers with the FDA

    There are three essential factors that need to be considered when deciding whether a new NDC number needs to be filed for a product: 1. Whether the label is different 2. Whether the formulation is different 3. Whether the packaging is different If any of these three elements changes, then this will trigger the need for new NDC numbering codes for a given product. Simply put, if the same product formulation is put into several different packaging sizes then this will trigger a new number. If …

  • 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 …

  • How a Pharmaceutical Consultant Can Improve Business Health

    No doubt, things are tough—and getting tougher—for the pharmaceutical industry today, especially for the smaller companies. They now have to buckle down and find ways to operate far more efficiently than in easier times. Every drop of value has to be squeezed out of every dollar invested in R&D, production, distribution, marketing, and sales. And this is where pharmaceutical consultants can help.

  • The Future of Regenerative Medicine

    Bioengineering, and more specifically, tissue engineering, gives a new perspective to personalized medicine. The use of cells and therapies has become a strong practice to get the body to heal itself, as it already happens with blood transfusions, bone marrow transplants, and autologous chondrocyte implantation to re-grow cartilage. These procedures have prepared the road for over 2000 clinical trials linked to cell therapies, like stem cells for ischemic heart regions, neural precursor cells …

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain! The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues. For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, and …

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain! The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues. For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, …

  • Is the Pharmaceutical Industry Going Green?

    Recent reports coming out of Europe and the United States are all showing that the pharmaceutical industry, at large, is taking tremendous steps into “Going Green”, so to speak.  Because of the recent economic decline, as well as market uncertainty, and overall economic uncertainty plaguing the Big Pharma industry, many pharmaceutical companies are doing whatever it takes to cut costs, and that includes looking for cheaper alternatives.  Recent studies indicate, that many large …

  • FTC Commissioner Rosch Will Speak at ACI’s Pharmaceutical Antitrust Forum

    … noticed on antitrust matters.  In fact, DOJ took back its previous position on reverse settlement agreements, and currently, both organizations consider these agreements anticompetitive.  There is pending legislation that could define, by itself, a prohibition on these agreements if several circumstances are not present.  This shows that the Congress is supporting the antitrust efforts of both organizations in the Pharma industry.  Moreover, the European Commission’s Directorate …

  • Patient Safety Resides in Global Thinking

    Now is the time to establish a global vision in the path to a harmonious approach to product security that provides close-term benefits for patient safety.  While the US centers on how to achieve an e-pedigree system and the Pharma industry in Europe incorporates a 2D datamatrix-based “bookend” system, patient safety is in possible danger due to the split approaches and expensive implementation strategies. The drugs supply chain is becoming more and more complex due to the increase in the …