Tag Archives: number

  • 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 …

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    … Lean consultant is well placed to provide objective feedback about the program to senior management and to maintain the commitment from senior management that is required in order to deliver lasting sustainable improvements to the business. This is by no means the extent of the benefits that can be delivered using a Lean consultant, but it does effectively highlight the diverse number of areas where they can have a meaningful impact. …

  • Don’t keep failing, implement a LEAN Laboratory approach!

    So your QC laboratory is failing to keep up with the manufacturing group. Your number of samples is increasing and there are new products coming down the road which promises yet more samples. Your laboratory analysts are working harder and longer hours just to maintain parity. Overtime costs are exploding and errors are increasing which is leading to more and more laboratory investigations. The pressure is mounting and there seems to be know light at the end of the tunnel. What do you do? …

  • 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 …

  • 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 …

  • New Data on the Inspection of Human Cell & Tissue Products by the FDA

    A recent report charting inspectional information by the FDA for human cell/tissue therapeutic products shows a marked increase in inspection activity. The period covered is 2003-2010 and reports an increase in the number of inspections by about 250%, with an average duration of each inspection of 40-45 hours. During that period, voluntary compliance actions taken by companies as a result of inspections has increased 255% and official action taken has increased 240%. This is against a background …

  • Critical factors in Filing NDC numbers with the FDA

    There are three essential factors that need to be considered when deciding whether a new NDC number needs to be filed for a product: 1. Whether the label is different 2. Whether the formulation is different 3. Whether the packaging is different If any of these three elements changes, then this will trigger the need for new NDC numbering codes for a given product. Simply put, if the same product formulation is put into several different packaging sizes then this will trigger a new number. If …

  • BARDA and their Countermeasures Initiative

    … be a number of significant challenges to be addressed including: long term stability/shelf life of countermeasures, platforms for warm based production, platforms for surge production capability and technology solutions to promote efficient product transfer from clinical production to commercial scale manufacturing. BARDA’s strategy to achieve this will most likely involve a number of public private partnerships and considerable funding investment to support the relevant activities …

  • Pharmaceutical Consultants-The Key to a Rapidly Changing Industry

    … from all sides, particularly through the impact of new technologies across the whole discovery and development process and from changes in the way that health care is funded and delivered.” The changes Peakman spoke of have progressed even further, and there are other, more radical changes than those he had in mind in 2000. Growing FDA intrusion and compliance burdens, a dwindling number of blockbuster drugs and looming patent expirations, slowing growth in the market and shrinking profit …

  • Microbiology: Transcending Waste With Lean Manufacturing

    … days to only 18 hours, greatly improving their ability to release products faster and reduce inventory. However, only 3% of manufacturing facilities had RMM systems in place in 2004, and by 2008 that number had risen to only about 10%. Clearly, many companies have work to do. With RMM technology in place, results for microbial contamination testing are available in hours instead of days. The sooner a manufacturer can determine that a batch is contaminant free, the sooner they can release held …

  • The Smart Road to Pharmaceutical Consulting

    Expenses surrounding R&D, production, regulatory compliance, marketing, and product distribution continue to increase. The cost of medication and various kinds of specialized health services continue to rise. In addition, the number of blockbuster drugs is dwindling, safety concerns are growing, and greater government intervention looms. All of this means that the value of and the return on investment for pharmaceutical consulting services are also increasing. Staying competitive and …

  • Counteracting Expanding FDA Reporting Requirements Through Lean Manufacturing

    … 2011. Lean manufacturing, however, may offer the solution. According to the Federal Register (vol. 75, no. 188, 29 September 2010), the FDA proposes to amend its “regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND),” allegedly to “improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the …