Tag Archives: complexity

  • Should we be using iPhone video procedures?

    The following post was written by Dr. Nigel J. Smart, Vice President and Managing Partner at Smart Consulting Group.  With the increasing complexity of operational procedures, the use of traditional standard operating procedures must be questioned, particularly for equipment or technique operation. The use of photographic techniques, pictures and other illustrations were long advocated benefits in other industries, yet the pharmaceutical industry continues to cling to practices that were right …

  • The Continuing Journey of Lean Manufacturing in the Pharmaceutical Industry

    … manufacturing solutions – is currently in flux. The industry has been attempting to embrace lean manufacturing since about the 1990s, often with less than glowing success. Today the industry is faced with the ongoing dilema of how to sustain quality while simultaneously dealing with increasing complexity on several fronts. Much of this complexity stems from cost-cutting measures such as the use of contract manufacturing organizations (CMOs), a practice that requires managing multiple …

  • Building an Optimal Quality System

    … the heaviest burden, mainly steps 2 and 3, managers need to address all stages with appropriate time and energy. Any life sciences consulting firm will tell you that a quality system, regardless of its type or complexity, is never fully an entity unto itself.  For any quality system to work correctly it needs to have managers on site that are not only familiar with the system, but are dedicated to its maintenance and ongoing success.  This is why it is critical that any quality system plans …

  • Patient Safety Resides in Global Thinking

    … globalization of the pharma trade.  Manufacturers, distributors, re-packagers, and retailers may be all located in different countries or even continents.  Given the complexity of the supply process, drugs have become a profitable target for illegal distribution and forgery. Many methods have been proposed to protect patients, however, the answer may be very simple: an approach in phases, which initially focuses on the point of dispensing and avoids the significant difficulties and costs that …

  • Ensuring QC for Laboratory Operations

    In order to assure that a company has a well functioning organizational structure executive management needs to be very proactive. No where is this more the case than in the QC laboratory environment. Audits and warning letters are very common within the pharmaceutical industry, and issues connected with both of these are very common in dealing with  laboratory operations. Given the complexity of QC operations, situations where this is under control is impressive given the criticality relative …

  • FDA Resolves Compliance Issues with Drug/Device Combination Products

    … produced by different manufacturers. Another issue that arises is the complexity of drug/device combinations. Combined products could be as simple as a syringe pre-filled with drugs. They also could be as complex as chemotherapeutic drugs combined with monoclonal antibodies. The U.S. Federal Drug Administration (FDA) has made it a top priority to address these ongoing compliance issues. They developed the Office of Combined Products (OCP) which was a result of the Medical Device User Fee and …

  • How to Develop New Employee Orientation Programs for GXP Compliance

    … Enforcement Administration) •    DOT (Department of Transportation) •    EPA (Environmental Protection Agency) Another tip is to pose sample regulatory overlap scenarios and guide discussions accordingly. •    Facilitate discussion of “standard operating procedures” (SOPs) and provide guidance as to how new hires can handle these situations according to SOPs. •    Present principles and address how new hires should respond to regulatory complexity issues, especially when …

  • The Pharmaceutical Industry Gets Six Sigma and Lean Manufacturing

    … Lean manufacturing, in order to gain stronger organizational skills at the management and general staff levels. IT is vital in the transitioning process to ensure constant improvement.  The complexity of the manufacturing processes makes it necessary to acquire flexible and practical IT systems.  Data gathering and analysis must occur fast, effectively, and accurately; improving reliability. The reliability aspect makes this information the basis for guiding, decision-making, and cost …

  • How To Implement Lean In The Lab

    Though the concept of “lean” originated in the car industry, most manufacturing businesses have adopted its principles as the best way of improving efficiency and reducing costs. Analytical and microbiological laboratories are embracing this trend too, though the volume of samples is definitely lower, and with a high degree of variability and complexity. For this reason, the application of this management model requires some changes and adjustments to the generic approach, though the leading …

  • Sustainable Pharmaceutical Manufacturing

    … out of sustainable development chemistry, the constructs must be an inherent consideration and ingredient in the initial design of complex synthetic processes. Although the complexity of pharmaceutical manufacturing for chemical syntheses is a big roadblock for change, processes are being improved, pharmaceutical companies are influencing their chemists, and they are responding. Economic incentives are becoming the main interest towards sustainable development chemistry; it pays to go green.  …