Tag Archives: pharmaceutical industry

  • Should we be using iPhone video procedures?

    The following post was written by Dr. Nigel J. Smart, Vice President and Managing Partner at Smart Consulting Group.  With the increasing complexity of operational procedures, the use of traditional standard operating procedures must be questioned, particularly for equipment or technique operation. The use of photographic techniques, pictures and other illustrations were long advocated benefits in other industries, yet the pharmaceutical industry continues to cling to practices that were right …

  • SCG’s thoughts on the last 10%

    For the pharmaceutical industry, it is difficult for consumers to tell the difference between an excellent, acceptable or poor quality product.  For this reason, safety, quality and reliability problems can go undetected  until the FDA detects them during an inspection or after investigation for a product recall.  By then, the problems can be out of control and can result in a Warning Letter or Consent Decree. The below excerpt can be found here: “ // // Seth’s Blog: The …

  • WHO Ebola Vaccine Meeting

    … has only continued to develop.  During the meeting, the leaders of WHO collaborated on the ways in which to establish a sensible approach to combat and stop the spread of this deadly outbreak. So what are your thoughts on the vaccine discussion? Let us know here  ! The below article excerpt originally appeared here: “A high-level emergency meeting, convened by WHO at the request of several governments and representatives of the pharmaceutical industry, was held on 23 October to look at the …

  • Kaizen Events

    … concept to take away is that each person involved in these events plays a key role in its process. In the pharmaceutical industry one accomplishment is only the next “go ahead” to the next big idea and so on and so forth. Although time consuming, high-detail follow-up work is a must in order to best monitor and fine-tune each method. It is with this type of work that you will see adequate success with Kaizen events. Let’s first just rewind a bit and explain what is involved with a Kaizen …

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    … apparent, so to have a Lean consultant that knows the pharmaceutical industry will speed up your process and help to deliver tangible results using the most efficient deployment of your resources. Relative to this, the consultant will take pressure off the line management during the difficult process of culture change that is often required to produce a successful program. They do this by using their expertise and experience to demonstrate how the new approach and methodology will benefit the …

  • Lean Philosophy and the Life Science Industry

    It’s generally accepted that standard Lean approaches have not been well implemented in the pharmaceutical industry.  We feel that this is largely  due to a lack of appreciation of the complexities of manufacturing according to cGMP which is a necessity to be in regulatory and quality compliance. Although many of the basic principles of a Lean philosophy can be applied to the highly regulated Life Science Industry, implementation is often more complex due to the very stringent requirements …

  • 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

    When market conditions, and methods of manufacturing, testing, and technology remain virtually unchanged for long periods, companies within that industry generally manage quite well doing everything in-house. However, when an industry finds itself in the throes of rapid and unexpected change, outside experts are often needed to provide the knowledge and expertise necessary for corporate survival. That is exactly where the pharmaceutical industry is, and why the value of pharmaceutical …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    … analysis, process control, and continuous improvement. With these tools, pharmaceutical manufacturers can move toward the common goals of reduced cycle times, fewer rejects, increased automation, and continuous improvement in the process that are shared by PAT and lean manufacturing. The pharmaceutical industry has historically taken a reactive approach to process and quality control – that is, issues were addressed as they arose and not before. Today, however, the industry is moving away …

  • 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 …