Tag Archives: way

  • Should we be using iPhone video procedures?

    … progressive about the way we communicate instructions for our processes, particularly since almost everyone has a smart phone more commonly today than a wrist watch, for example. The old adage that pictures are worth a thousand words is true in our industry and very relevant when communicating across numerous languages. As a final word, we should not hide behind the excuse that these are not controlled records like SOP’s since we have the technical capabilities to address this issue …

  • Fall Networking Event, a Success!

    … 25-30 attendees! It was an amazing way to connect with business professionals from a wide array of industries, opening up the SCG network beyond the life sciences industry. We’re excited to announce that this is just the start of happy hour/networking events of this type for SCG. We are already in the works of planning our next networking event in the borough, so stay tuned! We appreciate all of the support we get from the local community and we only hope to expand our community reach with the …

  • 483 Audit Forms

    … should not go unnoticed. A 483 audit is issued after the conclusion of an FDA inspection. This form states that certain conditions were cited as “in violation” of FDA standards/regulations. The FDA investigator feels that the practices or conditions surrounding the product at hand is in question and therefore a change needs to be set forth, in order for operation to continue. A company must understand the problem at stake as well as the violations that are in play as a way to avoid an …

  • 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 …

  • Risks in Lean Compliance

    … hurts to dig a little deeper to understand what COULD go wrong. In the long run, your research will thank you, your team will thank you and you will be thanking yourself when you see profitable and successful results come through in the end. Don’t be afraid to take a scientific risk, as we need risk takers in order to lead the way to new possibilities. Just be sure to account for potential risks in order to be well equipped within your biopharmaceutical process. For more information about …

  • Flow Charting

    … principles defined in developing the flow of process: Process starting point Tasks/Actions Decision points (Yes or No) Tasks/Actions after the established decision has been made Process End Point A concise way of developing and analyzing potential medical products, the flow charting method is an effective way to ensure that the active materials in question are in line with the medical guidelines set forth by the industry. It is no question that flow charting can alleviate much of the time and …

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    … things in a certain way. The whys, the where’s and the how’s of the situation are examples of where a Lean consultant to can play a significant role in your program. As an experienced extension of your team the consultant can quickly run a diagnostic assessment of key processes, gaps and weaknesses associated with your Current State and can get you tracking quickly. Deciding what tools to use and how to use them and provide the largest bang for your buck is also not always immediately …

  • 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

    … 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 …

  • Lean Manufacturing for the Competitive Edge

    … of production, and cut costs without compromising quality. Sue Capps Morris, Senior Vice President of Manufacturing Operations- Americas, summed up the benefits of lean manufacturing solutions for Merck this way: “By implementing, we will completely transform how we manage production, view our work, organize our business, and, ultimately, we will change our culture to a ‘lean-thinking and performing’ one.” In this time of shrinking profit margins, and increasing pressure …