Tag Archives: fact

  • Best Practices of Smart Consultants

    … assignment, but we advise against the long-winded lectures. What to do if this sounds like you: Be the action maker, the one who raises the questions that no one else may think of right off the bat. Take your love of the industry and channel it into thought-provoking suggestions to better move your team forward. Your team and client, for that matter, will thank you! If you’re not the professor of your squad, but have a secret desire to constantly fact-check your team you run into a whole new …

  • Consolidation Activity in the Generic Sector

    Consolidation within the generic industry continues to occur at breakneck speed through merger and acquisition activity. Multiple major players are engaged in not one but several mergers simultaneously, a fact that’s perhaps confusing to some people on their respective supply chains. Integration activities often spawn their own issues as organizations with quite different cultures are fused together to blend product portfolios. These do not often fit easily and new strategies need to be …

  • Waste Removal

    Waste Removal Lean Biomanufacturing, Dr. Nigel J. Smart The million dollar question in lean biomanufacturing is (drum roll please)….how can we go about removing all of that waste? Although the process seems rather grueling, trust in the fact that waste removal is beneficial to your research. Waste removal will have a major impact on your team’s overall biomanufacturing goals. Yes, sometimes various components of your research cannot be eliminated. And if that is found to be true within your …

  • 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 …

  • Lean Manufacturing Solves Drug Recalls and Bad Press

    … new blockbuster drugs, and the cost of bringing new drugs to market running in the neighborhood of $1.5 billion, drug companies are struggling. The opportunity for them to benefit from a new image and from lean manufacturing implementation is at hand. Lean manufacturing techniques do work, but effective implementation in the pharmaceutical industry requires knowledge of the special circumstances that exist in the industry, i.e. the difficulties involved in altering batch sizes, the fact that …

  • 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

    … that Toyota’s production, in fact, became less lean. Toyota, whose inventory turns fell dramatically from the 1990s to 2008, became too focused on growth, and lost sight of their goals of quality and continuous improvement. Management, it seems, forgot that lean manufacturing implementation is a continuing journey and that culture is key. There is a lesson for the pharmaceutical industry here as well. The pharmaceutical industry – as well as its pursuit and implementation of lean …

  • Making Relationships Count With Life Sciences Consulting

    … Perhaps the greatest challenge involved in outsourcing to CMOs lies in the fact that the CMO-sponsor relationship and, as a result, management protocols are still evolving. This can result in relationships with, and management, of 10 or more participant sites – especially for complex processes like those in the manufacture of biological products. Obviously there is an enormous opportunity to benefit from life sciences consulting here. While utilization of CMOs is growing, the management …

  • Counteracting Expanding FDA Reporting Requirements Through Lean Manufacturing

    … drug, expedite the FDA’s review of the critical safety information, . . . [and] promote a consistent approach to safety reporting internationally.” The potential problem lies in the fact that some of the language is imprecise, ambiguous, and may impose further compliance and reporting burdens on pharmaceutical manufacturers. For example, a “suspected adverse drug reaction” is defined as a “noxious and unintended response to any dose of a drug product for which …

  • Transforming the Traditional Approach with Lean Manufacturing Techniques

    … techniques has meant, in some cases, an improvement in throughput time of as much as 70%. A successful implementation of lean manufacturing techniques and the pursuit of lean’s ancillary goal of continuous improvement often require, especially for a pharmaceutical manufacturing firm, a change in culture, in mindsets. Resistance comes from the fact that people don’t want to change their customary way of doing things and from the worry that speeding up processes could lead to …