Tag Archives: solution

  • 483 Audit Forms

    … need to take place. If you receive a 483 Citation and are not sure what to do next, make sure to reach out to experts in FDA consulting services…a group you can trust. The professional team at Smart Consulting Group  has many decades of experience in remediating FDA compliance issues. Give our team a call today. We look forward to helping your company reach a positive solution!   * The above facts noted, regarding 483 citations, were referenced from the FDA’s website. For more …

  • Poka-Yoke as a Mechanism to Assure Reliable Production of Pharmaceuticals and Other Life Science Products.

    … all leading to contamination issues. 6. Flow values installed backwards. 7. In QC laboratories, analysis errors due to the analysis being started prior to the system meeting stable system suitability requirements. 8. Inappropriate use of dispensers in media preparation for bioreactors resulting in X10 components added to the media or buffer solution damaging the yield of the production batch. Clearly these examples are all avoidable provided a comprehensive Poka-Yoke program is included as part …

  • Pharmaceutical Consulting and BMI’s 4th Quarter Update

    … examine each situation and problem from every perspective then, through analysis and testing, formulate multiple possible solutions. Management and consultants then work together to determine the best solution. Some of the critical areas that pharmaceutical consultants can provide assistance with are: Quality and compliance Good manufacturing practices (GMP) FDA regulatory concerns and adherence Laboratory services Lean manufacturing Training and coaching Smart Consulting Group is …

  • Pharmaceutical Consultants Broaden the Scope

    … pharmaceutical consultants provide with respect to attitudes and the way people approach problems and solutions. Why is this important? Because the way we view a problem determines in large part whether or not we find a solution for said problem, and how effective it will be. On September 11, 2001, the unthinkable happened. Foreign terrorists attacked Americans on American soil, killing and maiming thousands. The terrorists, some of whom were living in this country and had been educated here, …

  • The Right Sequence for Lean Manufacturing Implementation

    … production in the outsourcing country. Is this really the best solution?  Wouldn’t it be better to apply lean manufacturing solutions, eliminate waste, continuously strive for more efficient production processes, and become more responsive to customer demand? Due to the compartmentalized nature of departments within the pharmaceutical industry there exists a separation between manufacturing and R&D – a separation that has had far-reaching consequences, the weight of which are …

  • Hiring a Pharmaceutical Consultant: 7 Steps to Success

    … situation. Instead, what is needed is for your consultants to look at the problem(s) from every possible angle and perspective, analyze and test ideas, and then develop multiple potential solutions. Then, together, you can decide which solution will be the best one – not only now, but also in the long run. Flexibility doesn’t end there, however. For example, the project associates with Smart Consulting can even work as substitute staff and as temporary team members if need be. 4. …

  • Making Relationships Count With Life Sciences Consulting

    … methods are often the same methods used 10 or 20 years ago. Consequently, this strategy very often falls short of achieving the maximum potential value for life sciences companies. Initially, the CMO-sponsor relationship was entered into chiefly as a tactical, specific solution. Later, owing mostly to quality issues that began to crop up, central governance was created. And more recently, in the effort to build global networks, emphasis has been on the supply chain. The dynamics between CMO and …

  • Avoiding the Pitfalls of Pharmaceutical Consulting

    … recipe for less than stellar results. The pharmaceutical consultant you choose should have the ability to view and analyze your situation from various viewpoints and perspectives, the willingness to find and test multiple potential solutions, and the experienced personnel to step up and fill in where needed. To illustrate, here’s how Smart Consulting Group handles the solution-finding process in a manner that incorporates flexibility and leads to long-term results. The consultants with Smart …

  • The Smart Road to Pharmaceutical Consulting

    … company and their unique problems, viewing them from various angles and multiple perspectives, the pharmaceutical consultants with Smart Consulting are able to discover, develop, and propose numerous possible solution options. They analyze and test ideas before defining a solution and make adjustments as necessary in these early stages. They then create multiple potential solutions and test to determine which one will be the best fit for the problem at hand. But they don’t leave it there. They …

  • 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 …

  • Behind The Increasing Need for Pharmaceutical Consultants

    … may be a viable solution, it carries with it potential dangers that could be very costly. According to Nigel Smart of the Smart Consulting Group The company is still responsible for meeting drug-manufacturing regulations, as well as other government requirements. Ultimately, the holder of the license—the pharmaceutical company or biotech—is the one who will have to answer to the government, or deal with lawsuits. Smart offers this warning: “As one goes farther afield from one’s home …

  • Lean Manufacturing Implementation: Successfully Overcoming Obstacles

    The current economic climate, combined with increasing regulations has placed pharmaceutical manufacturers in the difficult position of having to reduce waste, improve processes, and increase productivity. Although lean manufacturing can absolutely be the answer, some companies have found lean manufacturing implementation to be an uphill battle. That is not to say, however, that there have not been some dramatic success stories.