Tag Archives: terms

  • 483 Audit Forms

    So what’s with this 483 audit form and where do I go from here? Faced with a 483 audit form? If this is the first time your company has received a document of this nature your initial thoughts may be… now what? In order to understand the true implications of a 483 citation, it may help to think of it in terms of a speeding ticket. It’s a road block or a cause for reevaluation of your current state. Although not necessarily a serious offense, it’s an important warning to your company that …

  • The Pharmaceutical Consultants Role in Lean Manufacturing/Biomanufacturing Processes

    … company and the workforce equally. This communication role will be vital if the grassroots is to be activated and ideas and practices are to go viral in terms of their acceptance. Through a structured training program the consultant can educate the senior management, core team and workforce in the philosophy and importance of the key steps that will need to be embraced and lay the necessary groundwork to ensure that the initiative gathers continuous momentum. When the going gets tough the …

  • 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?

    So you may be a start-up or virtual life sciences company, but you still have a requirement to have a Quality System to develop your pharmaceutical/life sciences products. That’s true if you are a company that is regulated by the FDA and major international regulatory agencies that conform to ICH guidelines. Although you’re not likely to be inspected as an early stage company, regulators still expect that developers of human products must be stage appropriate managed in terms of compliance …

  • The Right Sequence for Lean Manufacturing Implementation

    … downtime later on—a step that enhances effectiveness first in order to promote manufacturing quality and efficiency over the long run. A complete, successful lean manufacturing implementation requires a shift in paradigm from top to bottom—changing the emphasis to thinking about processes in terms of continuous, ongoing improvement. According to Thomas Friedli (“Operational Excellence: Pharma’s Missed Opportunities,” pharmamanufacturing.com), “This challenge is never …

  • The Smart Road to Pharmaceutical Consulting

    … profitable is getting tougher for pharmaceutical companies – especially smaller firms, as well as health care organizations. John R. Kimberly, Management Professor at Wharton University of Pennsylvania, warns that the “old model is dead, and big pharma is struggling to come to terms with what new model is going to work.” The trick then is figuring out exactly which of the myriad of potential solutions will enable companies to remain competitive and stay in the market. Added to that is …

  • 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.

  • Key Factors in Third Party Testing on Combination Products

    … under what jurisdiction it will fall under.  Due to the large variations between the different levels of FDA research and testing departments, there are huge variations in terms of time and money required for FDA approval.  Because of this, a combination product’s designation to a particular department could have a major impact on the company’s ability to finance the product.  Because of this large variation, it has become a tremendous financial burden to some drug manufacturers, …

  • The Role of Interim Monitors in Divestitures

    … consider this a “black box” approach, and feel that there isn’t enough transparency in these types of divestitures. During divestitures of significant magnitude both parties go through great lengths to ensure that any kind of divestiture intended to remedy the anticompetitive effects of the merger is sufficient to preserve a post-merger competitive market. In simpler terms, the goal of the divestiture is to ensure that the purchaser or acquirer of the divested assets can …

  • The Global Vaccines Market, 2008-2023

    From 2008 until 2023 there will be an improvement in vaccines, and their sale and use will experience a rebirth.  Vaccines will be one of the fastest growing areas of the pharmaceutical industry, and their profits will increase by the hundreds in percentage terms during this period. The Global Vaccines Market, 2008-2023, is a report that describes the market trends in a qualitative and quantitative manner.  Vaccines have grown in importance in developed as well as developing countries because …

  • The 6 Crucial Principles in Pharmaceutical Leadership

    … conditions.  In order to synchronize global communication, there may have to be some compromise in terms of standard working practices. –    Awareness.  Some employees may not realize they are a part of a virtual team, requiring training in new ways to work. –    Project phases.  Employees have to be trained in which communication channels work best for different projects and their phases. –    Roles and responsibilities.  Team members must recognize the skills, …