Tag Archives: approach

  • Best Practices of Smart Consultants

    A fresh, new start…a brand new you? What kind of consultant are you and who would you like to be in 2015? As we approach the last week of the first month in 2015, if you’re like us, you may have done some self-reflecting, both professionally and personally over the last several weeks. New Year’s resolutions might be in full swing or could have possibly even been forgotten by now. A major question people ask themselves each New Year is: Who do I want to be in 2015? As a pharmaceutical …

  • 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 …

  • Bottlenecking Theory

    … make the most out of your research. You are experts in your industry so make sure to own this knowledge, for that will be the best way to reach your team’s goals.   The quantity that a manufacturing site can produce in unit time is defined as: Plant throughout: Batch size X Number of batches Plant throughout: Batch Size/Cycle Time Clearly bottlenecking is not an ideal situation for your facility, so avoiding this or creating a logistical approach to offset this phenomenon is key in lean …

  • Fishbone Analysis

    … biopharmaceutical process. For anyone who is familiar with lean biomanufacturing, one may already know that lean is most commonly identified in the biopharmaceutical industry as a “holistic and sustainable approach that uses less of everything to produce more.” The financial burdens of today’s economy most certainly play a key role in this industry, which is why researchers utilize proactive methods of experimentation to best identify problems early on in their research. A standard …

  • Lean Biomanufacturing: Keeping Your Eye on the Quality Goal

    … damage of patient’s lives. From experience we know that these situations kill the product commercially and ultimately harm the brand of the company for future pipeline products. So the case for building and maintaining elements necessary to assure appropriate quality standards in a medical products manufacturing process are integral in the overall strategy for production and sale of the product. In more recent times Toyota’s Lean approach to manufacturing has been blamed for the fall in …

  • 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 …

  • Leachables and Extractables in Biopharmaceutical Processing

    … With all this activity going on its often helpful to solicit the help of a consultant that is aware of the issue s to help guide a path forward. In developing protein therapeutics that may be sensitive to contact with rubber and plastic components, the potential effect of Leachables over time can become a critical processing consideration. To help to address this issue, part of the modern approach is to use Risk Assessment and Risk Mitigation strategies to first quantify the extent of the …

  • Do Start up Life Science Companies need Quality Management Systems?

    … pay for the convenience of an in-license, but if there are regulatory issues as a result of a lack of quality oversight they may be less inclined to pay top dollar as some of that amount may be needed to address regulatory short falls. A better business & compliance approach is to do it right first time and to initiate a flexible and expandable Quality System strategy. At SCG we offer a fully expandable and serviceable Quality System that’s been tried and tested over a number of years at …

  • Lean Product Change–Over in an FDA Regulated Environment

    … compliance functions, where as Lean requires similarly strict adherence to operating modalities that assure efficiency, repeatability and overall process capability. Where much of the conflict appears to reside is in relation to how that execution is achieved. However, with the advent of recent new guidance documents which include GMPs for 21st century, ICH Q8, Q9 & Q10, we’re seeing a more pragmatic approach to compliance that is more systematic and which lends itself to fit naturally …