Tag Archives: changes

  • Flow Charting

    Getting to Know Flow Charting in Lean Biomanufacturing Lean Biomanufacturing, Dr. Nigel J. Smart When it comes to lean biomanufacturing, flow charting is deemed as one of the most basic techniques for defining what is required to operate a particular process. It is no question that the biopharmaceutical industry has evolved quite tremendously in recent years, and as we adapt to these changes, it’s vital to understand the progression in which the industry is transforming. The pharma industry is …

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

    … First, have an experienced Lean laboratory consultant on your team. Second, work with them to develop a plan that will transform how you’re running the laboratory operations. Third, make a commitment to integrate the QC laboratory as part of an overall operational strategy so that the laboratory is not an isolated function that’s exposed to changes in production priorities. So what are some of the important factors that we need to consider in transforming the current situation to a Lean …

  • NDC codes: National Drug Codes and How They are Assigned

    … individual company. In practical terms then, should a packaging size change for the product and if the same product is manufactured in the same location, then the codes would change and a unique code would be required for that packaging configuration/size. Similarly if the packaging size was the same but the formulation changed, then the code would also change to a new unique number for that formulation. changes in the product which force a change in the label would also trigger a change in the …

  • Reaching into Research and Development of a Supply Chain Strategy

    Critical materials and suppliers are selected early in development. By the time Technology Transfer occurs for commercialization, it is often too late to make changes to these critical components without having to do additional testing or even repeating clinical trials. Regulatory authorities have made securing the supply chain a priority and have promised serious repercussions for companies and their management who do not manage risks to the supply chain. We propose developing a strategy for …

  • Change Management; A Vital Part of the Lean Mechanism within the Life Sciences Industry.

    The deployment of any successful Lean initiative will be largely dependent upon the capacity of the organization to adopt the changes that are part of the overall approach and a major driver for this will be how the workforce chooses to embrace the methodology involved. Within the Life sciences Industry, this effect is often even more pronounced due to the highly regulated nature of the business processes involved. No matter how effective the methodology is, if it is not welcomed, embraced and …

  • Lean Approaches in Bioprocessing to Help Minimize Variability in Production Yields

    … upstream and downstream ends of a process and this is frequently due to poor operational control. As a result, throughput falls due to the failures and extra “belt and braces” measures are often applied to “make sure” that the failures don’t re-occur. This has the effect of increasing the cycle time and reducing productivity. A better strategy is to take a holistic approach and identify the roots causes and then make appropriate changes to prevent re-occurrence. Simple in concept but …

  • 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 …

  • 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

    … The highly compartmentalized nature of the industry fosters a manufacturing process composed of many individual parts rather than one continuous, integrated flow. Improving a process that isn’t quite a process yet can be very challenging. Additionally, there’s a reluctance to make the necessary changes – batch size,for instance – when those changes result in the added burden of extensive documentation and testing. As with PAT, the very things that need improvement are …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … Leadership Ability Consultants don’t just assess and advise – they also lead. They not only have to be able to gently persuade members of an organization to accept and adopt proposed changes, they must also possess the ability to imbue both management and employees with a little of their own passion. Good consultants who are good leaders have the following attributes: the ability to take action and overcome obstacles, a commitment to fostering and nurturing commitment, creative …

  • Avoiding the Pitfalls of Pharmaceutical Consulting

    … changes Hands-on technical execution Effective team-building Finding common goals and creating a vision Subordinating their own needs to the organization’s goals Recognizing the difference between management and leadership Creating loyalty, commitment, and building trust 4. Neglecting the Relationship Aspect Perhaps the most important part of a pharmaceutical consulting arrangement is the relationship involved. A consultant first has to gain the client’s trust (on several …