Tag Archives: and the

  • Consolidation Activity in the Generic Sector

    … developed to assume that products will remain available to consumers at the right price. As producers drop out, monopolies are developed and the Federal Trade Commission is obliged to step in to protect competition and consumer choice.  This involves its own level of management which can also put stress on the company to deliver products to the consumer. So beneath the economic/business surface news of an acquisition/there’s the underlying practical considerations which may be overlooked …

  • WHO Ebola Vaccine Meeting

    … charity, funding agencies and foundations, the GAVI alliance for childhood immunization, and development banks, including the African Development Bank, the European Investment Bank, and the World Bank Group. Main conclusions reached Impact of vaccines on further evolution of the epidemic The meeting concluded that vaccines will have a significant impact on the further evolution of the epidemic in any scenario, from best-case to worst-case. Financing of vaccine development, clinical trials, and …

  • 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 …

  • Flow Charting

    … cost that is potentially at stake when developing pharmaceutical/biopharmaceutical products. For further information on flow charting and the overall pharmaceutical development process, please refer to the publication, Lean Biomanufacturing, by Nigel J. Smart.   …

  • 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 …

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    … things in a certain way. The whys, the where’s and the how’s of the situation are examples of where a Lean consultant to can play a significant role in your program. As an experienced extension of your team the consultant can quickly run a diagnostic assessment of key processes, gaps and weaknesses associated with your Current State and can get you tracking quickly. Deciding what tools to use and how to use them and provide the largest bang for your buck is also not always immediately …

  • NDC codes: National Drug Codes and How They are Assigned

    The NDC code is a 10 digit code that is applied to uniquely identify products having a drug registry component. The number is a 3 segment number in terms of its construction and the various components correspond to sections responsible for the label, the product and the packaging. The first section identifies the labeler code, is assigned by the FDA and it identifies any manufacturer (including re-packagers or re-labelers) or distributer (under their own name) of the drug or drug containing …

  • Issues Connected with Device Combination Product Convenience Kits

    … often can be best addressed using the experience of a pharmaceutical consultant to structure a creative path forward. Whatever the testing results however, manufacturers still need to know what their exposure is and the regulatory authorities will require evidence to show that practices are safe. …

  • 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 …

  • Eliminating Pharmaceutical Manufacturing Chaos through Implementation of an Effective 5S Program

    … will require constant attention so that new working practices become habits which are automatic actions of human behavior.   Achieving successful 5S implementation like all of Lean implementation will require significant commitments from senior management and the workforce to overcome the inevitable resistance that is naturally associated with significant change. Overcoming this resistance through cultural change will be the real challenge in implementing this Lean tool, but organizations …

  • Lean Enterprising; A term coming of age in the Implementation of Lean in the Life Science Industry

    … As a result more integrated approaches now involve the inclusion if IT/IS systems and networks, production control systems, supply chain and supplier networks, compliance & regulatory systems and the use of the organization’s human resources.. Proper integration of these factors, where there is a focus on proper human resource development & their application to waste minimization, and an emphasis on customer driven production, is at the heart of the new 21st Century paradigm for the …