Tag Archives: pharmaceutical consultancy

  • 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 …

  • 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 …

  • Issues for Device Combination Products

    The development of medical device combination products convenience packages continues to present interesting technical and regulatory issues. Inclusion of pre-sterilized syringes and applicators as part of these products poses problems for manufacturers and distributors due to the opportunity for post sterilization residual contamination and/or plastic leachables/extractables. Most device convenience kits are ETO sterilized and this can leave ETO residuals on applicators and syringes if …

  • BARDA and their Countermeasures Initiative

    Last month was the PHEMCE conference in Washington DC which translated the governments approach to countermeasures production for the next decade or so. From the discussions it appears that BARDA will be placing a greater focus on CBRN (Chemical, Biological, Radiological & Nuclear) countermeasures issues in the future than it has in the preceding 5 years when there’s been a heavy emphasis on flu related countermeasures, H1N1, for example. In addressing these issues there would appear to …

  • Pharmaceutical Consultants-The Key to a Rapidly Changing Industry

    … consultants is becoming undeniable. In a ten-year-old article titled “Industry Focused: pharmaceutical consultancy” (Science, 17 November 2000), Tim Peakman offered some observations that are far more relevant now than they were then. He wrote: “The pharmaceutical industry has undergone radical changes in the last 15 years. It has trimmed the fat and become more efficient, but in the next 2 to 5 years the way it operates is going to alter fundamentally. Change is being driven …

  • 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 Solves Drug Recalls and Bad Press

    In 2009, drug recalls reached an unprecedented high of 1,748. These recalls are attributable, in large part, to outsourcing and indiscriminate cost cutting. Today, more recent drug recalls and the resulting bad press are forcing the pharmaceutical industry to shift their focus to the manufacturing aspect of the drug production process. This latest rash of drug recalls has also intensified both consumer and media backlash against the pharmaceutical industry. A few examples of the most recent …

  • Pharmaceutical Consulting and BMI’s 4th Quarter Update

    Over the next five years, pharmaceutical consulting could be positioned to play an increasingly critical role, according to the latest estimates from the Business Monitor International’s Pharmaceuticals & Healthcare Business Environment Ratings. Although the US pharmaceuticals market is currently ranked first both regionally and internationally, projections for the fourth quarter of 2010 and beyond indicate that industry growth is likely to be meager at best. Indeed, the compound …

  • 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 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 …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    Maintaining a competitive edge in today’s pharmaceutical industry is becoming more and more difficult due to rising costs, increasing regulatory burdens, and greater government intervention. Hiring a pharmaceutical consultant can be a smart decision, but how do you determine which consultant is right for your company? Let’s examine a few key considerations. The goal of pharmaceutical consulting is to fill gaps. A good consultant looks at where you are now and where you need to be, …