Tag Archives: procedures

  • 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 …

  • Eliminating Pharmaceutical Manufacturing Chaos through Implementation of an Effective 5S Program

    … and cluttered workspace. Systematic: Now the space is clean and orderly, a process to maintain this condition should be established to assure consistent and sustained performance. Standardize: This process is involved in the crystallization of new working habits associated with the clean and organized work areas. This requires good procedures, training and commitment from the workforce including management and shop floor personnel if lasting sustainable performance is to be realized. Success …

  • Pharmaceutical Consultants Broaden the Scope

    It is a widely accepted fact that consultants assist companies by analyzing and assessing each individual situation and set of circumstances. Consultants then work with that company to design and implement appropriate programs, policies, and procedures based on those results. The final step is to advise, guide, and provide training in order to take the company from where they are now to where they need, and want to be. What’s far less well understood, however, is the value that …

  • Making Relationships Count With Life Sciences Consulting

    … eliminate certain internal practices and procedures, but there is a down side. The practice requires companies to manage multiple external relationships which often give rise to communication and quality issues, and sometimes compromise scheduling and supply-chain security. A 2008 study found that 91% of the participants that relied heavily on outsourcing had experienced what was termed a “significant incident” (one that resulted in a loss of $10,000 or more), as opposed to only 59% of those …

  • The Future of Regenerative Medicine

    Bioengineering, and more specifically, tissue engineering, gives a new perspective to personalized medicine. The use of cells and therapies has become a strong practice to get the body to heal itself, as it already happens with blood transfusions, bone marrow transplants, and autologous chondrocyte implantation to re-grow cartilage. These procedures have prepared the road for over 2000 clinical trials linked to cell therapies, like stem cells for ischemic heart regions, neural precursor cells …

  • Behind The Increasing Need for Pharmaceutical Consultants

    … still remaining competitive. One of the three main drivers in the push toward outsourcing is, of course, FDA regulations. A few of the major developments in the last few years are: August 2002: The FDA set in motion a new initiative entitled the Pharmaceutical Current Good Manufacturing Practices (cGMP) for the 21st Century: A Risk-Based Approach. This initiative focuses on the risks to public health that could result from flaws in manufacturing procedures. The stated purpose is to ensure that …

  • Innovative R&D Through Lean Manufacturing Principles

    … R&D also requires a significant degree of standardization in processes. The fact is there is a dynamic, reciprocal relationship between innovation and standardization in any R&D department. Innovation requires reproducibility of results which, in turn, requires standardization or Standard Operating procedures – SOP. If there is to be successful, ongoing improvement in the innovative processes within R&D, then there must also be standardization to insure accurate, unbiased …

  • The Benefits of Using Pharmaceutical Consultants

    … is owing to sharply increasing competition that drives prices down. If generics are doing poorly, that certainly doesn’t bode well for branded drug manufacturers. How can pharmaceutical consultants help? They can evaluate procedures, expenses, marketing and sales tactics, and then devise and implement the strategies needed to restore business health to drug manufacturers. Pharmaceutical consulting firms can also assist companies, especially smaller manufacturers, in gaining the competitive …

  • How a Pharmaceutical Consultant Can Improve Business Health

    No doubt, things are tough—and getting tougher—for the pharmaceutical industry today, especially for the smaller companies. They now have to buckle down and find ways to operate far more efficiently than in easier times. Every drop of value has to be squeezed out of every dollar invested in R&D, production, distribution, marketing, and sales. And this is where pharmaceutical consultants can help.

  • The Future of Regenerative Medicine

    Bioengineering, and more specifically, tissue engineering, gives a new perspective to personalized medicine. The use of cells and therapies has become a strong practice to get the body to heal itself, as it already happens with blood transfusions, bone marrow transplants, and autologous chondrocyte implantation to re-grow cartilage. These procedures have prepared the road for over 2000 clinical trials linked to cell therapies, like stem cells for ischemic heart regions, neural precursor cells …

  • FDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake

    … sponsor’s monitoring procedures and your interaction with the monitor. –    How did you account for the drug received, distributed to, or returned from subjects?  Were all drugs returned to the sponsor? Train your personnel to relate to the FDA.  You must show you are a professional and should answer questions in a direct way, without giving information they haven’t requested. When the inspector arrives First, check his ID, because you don’t want an unauthorized person …