Tag Archives: step

  • Best Practices of Smart Consultants

    … You want to be the consultant whose phone is always ringing because people want you on their team. Why? You ARE the right person for the job because you are prompt, dedicated, forward thinking and have the right kind of expertise. That’s the ideal consultant. You work well with your teammates and have an easy going spirit. You’re a pharmaceutical consultant, be proud to work in such an exciting industry! And you’ll find that once you take a step back and truly look within yourself as a …

  • Consolidation Activity in the Generic Sector

    … developed to assume that products will remain available to consumers at the right price. As producers drop out, monopolies are developed and the Federal Trade Commission is obliged to step in to protect competition and consumer choice.  This involves its own level of management which can also put stress on the company to deliver products to the consumer. So beneath the economic/business surface news of an acquisition/there’s the underlying practical considerations which may be overlooked …

  • Risks in Lean Compliance

    … identify potential risks before embarking on any sort of endeavor, especially something that involves time and money for your research team. By ranking and understanding the probability of various occurrences, based on a specific action or step in your process, you will have an overall better grasp on what could potentially cause issues down the line. If you’ve read SCG’s blog on waste removal, some of these concepts may not be unfamiliar to you. When identifying and understanding …

  • Waste Removal

    … as “low hanging fruit” components. Before going ahead and investing major time and effort into complex waste removal practices start with the materials that can most obviously be considered waste. Although this seems logical, many would be surprised at how many researchers overlook this step in lean biomanufacturing and instead strategize complex methods for removing harder to eliminate waste. Don’t fall victim to this practice. Don’t overlook the obvious. The effort to remove the most …

  • Kaizen Events

    … activity and something that should be heavily documented. These events can be tracked with special documents known as Kaizen storyboards. With a Kaizen storyboard one must first identify the problem or the current situation. The next part of the storyboard involves explaining one ideal situation. Following that step, one must pinpoint the target measures, such as target yield metrics or unit operation cycle time targets. The final sections of the storyboard include understanding the Kaizen plan …

  • Leachables and Extractables in Biopharmaceutical Processing

    … potential risk and then to subsequently ameliorate possible negative outcomes that are identified. This is a really important step and should be planned carefully as it can save a lot of effort if it’s completed according to a well defined approach. With the projected level of activity in using disposable production systems expected to increase markedly over the next 5-10 years, we can expect to see this area receive even more attention. Currently various industry associations are interfacing …

  • Issues Connected with Device Combination Product Convenience Kits

    … they’re included in the paper convenience trays. If manufacturers are to use these types of device combinations, then an alternative material of construction may be required to avoid this issue or possibly a modified sterilization cycle will be required which provides assurance of the removal of the sterilant. As a first step testing is needed to quantify the extent of the problem. Only when the size of this issue is understood can a resolution be developed. These are complex issues which …

  • Issues for Device Combination Products

    … they’re included in the paper convenience trays. If manufacturers are to use these types of devices, then an alternative material of construction may be required to avoid the issues, or alternatively a modified sterilization cycle will be required which assures the removal of the sterilant. As a first step however, testing is needed to quantify the extent of the problem before the right strategy can be developed. …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    … preventing companies from taking the necessary steps toward that improvement. While the principles of the FDA’s PAT initiative share similar goals with lean manufacturing solutions, and are well suited to work in unison, or at least in tandem, there are also similar obstacles preventing their full implementation. However, those obstacles are far less daunting when pharmaceutical consultants and lean manufacturing consultants step in to advise and guide the way. To learn more about how lean …

  • 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

    … now being fully felt.  Quality product development, however, depends on input from manufacturing.  Therefore, in accordance with lean manufacturing’s emphasis on seamless, unified production processes, ongoing two-way communication between manufacturing and the lab must be present. Industry analysts and lean manufacturing consultants suggest that, as a first step, effectiveness should be emphasized over efficiency. However, because the larger cost savings result from efficiency-driven …

  • Avoiding the Pitfalls of Pharmaceutical Consulting

    … Before hiring a pharmaceutical consultant, you absolutely must do the necessary preliminary work. Neglect these important steps, and you could be courting disaster: Identify and define your needs. The first step prior to calling in a pharmaceutical consulting firm is to carefully analyze and define your goals for your company. What, exactly, do you want to accomplish? What specific problems do you need solutions for? Knowing where you are now and where you need to be will be immensely helpful …