Tag Archives: reasons

  • 483 Audit Forms

    … escalation, like a Warning Letter, which is much more severe in nature. Yet, fear not. You will not be left in the dark after receiving this 483 audit form. The FDA will also provide a detailed written report, spelling out the specific reasons for the audit known as an Establishment Inspection Report, as well as all evidence or documentation that was extracted while the investigator was onsite. From there, depending on the severity of the case, the Agency will determine what kind of action will …

  • Fishbone Analysis

    … fishbone diagram follows a simple, yet systematic approach to understanding the potential downfalls of each of the mechanisms in a biopharmaceutical process (i.e. materials, methods, machines, measurements, environment, and people.) Using fishbone analysis, a team of researchers creates a list of reasons to identify various problems in their findings. When utilizing this technique, one of the best practices involves creating a simple chart (template) for the responses of the research time, …

  • Lean Philosophy and the Life Science Industry

    … process will fail for a variety of reasons. Integration of primary synthesis unit operations with those for recovery, purification and subsequent formulation and final finishing requires many break points, testing points and detailed production records. These are the elements that help define a process and often how this process is operated defines the chemistry and pharmacological activity and utility of the product. It is these factors that one needs bear in mind when adapting the principles …

  • Lean Manufacturing and PAT – The Next Level For Pharma

    … from that stance, and toward a quality-by-design approach – an approach that meshes well with the waste reduction, and continual improvement objectives of lean manufacturing. However, the pharmaceutical industry has been slow to take to both the PAT initiative, as well as lean manufacturing solutions, basically for the same reasons. The main obstacle, and probably the hardest to overcome, has to do with cultural issues and mindset. A deeply entrenched attitude of risk aversion in the …

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

    … ‘routine inspection’, prompted by a New Drug Application (NDA) submission.  The typical candidates for a routine inspection are clinical sites that enroll the majority of patients in the NDA’s critical clinical  trials. -‘For Cause inspections’ are not common, and are prompted when the FDA receives a report of, or becomes aware of, suspicious behavior.  Here are some reasons that may bring about such an audit: _ The carrying out of many clinical trials _ The carrying out …

  • How to Get Through a Successful Pre-Approval Inspection

    … verified.  But you may be asking yourselves, what are the reasons for pre-approval inspections anyways, and what can my company do to get through it, and pass it the first time around? The purpose of a Pre-Approval Inspection is for the federal government to ensure that all manufacturing facilities, as well as development facilities, meet all current GMP codes of conduct and stipulations.  Their main purpose is to verify that your company’s procedural activities are in line with their own …

  • New Stem Cell Technology Better Helping Bone Fracture Patients

    … of such immuno-isolated stem cell technology. But before this technology is widely administered to the general public, experts in the pharmaceutical consulting industry are saying it could be decades before we start to see any real benefits from this science.  This is due to several reasons.  One is that MSC Stem Cell isolation technology is considerably lengthy, not to mention extremely expensive.  MSC isolation technology can also be possibly harmful to the quality of the stem cells, …

  • Looking for Money in New Places

    There are many factors affecting small biotech companies today; however, liquidity takes the first place.  There are two main reasons why this is so: firstly, initial public offering (IPO) has been discarded as an exit way for investors, and secondly, available capital is decreasing fast because investors are not able to comply with commitments to existing venture capital funds, and the funds that are available are frozen into existing investments which for various reasons can’t be left …

  • The Exciting and Future Role Of Stem Cells in the Health Industry

    … only recently.  So what are the reasons for this heated debate about stem cell research, and what are the possible applications of stem cells in the future. You may wonder why there is any debate at all, over a medical treatment method, which may be able to cure some diseases that 20 years ago were thought of as altogether incurable.  But, as it often is, the discussion is much more complicated than it seems.  At the heart of the stem cell debate is the battle over abortion.  According to …

  • How Bioscience Companies are Using Social Media to Reach Key Audiences

    … into the interactive realm of social media, for various reasons.  The common belief was that implementing effective marketing strategies using social media was too difficult, given the legal and regulatory hurdles.  Also, the lack of a means to measure the financial success of using social media, has kept many pharmaceutical companies away from using these possible lucrative marketing tools.  However, signs are showing that these trends are starting to change. Many pharmaceutical consulting …

  • Manhattan Research Study Shows That Three Out of Four Nurses Recommend Health Websites to Their Patients

    … technology.  Normally, and just the same as a doctor, a nurse spends around eight hours a week surfing the Internet for professional reasons.  Most of this time is in between patient consultations.  Also, nurses proved to be very active and interested in learning about medical product information online; more than eighty percent have clicked on biotech, pharma or device companies’ websites during the last year, especially Merck, AstraZeneca, Pfizer, Sanofi-Aventis and Eli Lilly. Even though …