Tag Archives: facility

  • Bottlenecking Theory

    … make the most out of your research. You are experts in your industry so make sure to own this knowledge, for that will be the best way to reach your team’s goals.   The quantity that a manufacturing site can produce in unit time is defined as: Plant throughout: Batch size X Number of batches Plant throughout: Batch Size/Cycle Time Clearly bottlenecking is not an ideal situation for your facility, so avoiding this or creating a logistical approach to offset this phenomenon is key in lean …

  • The Right Sequence for Lean Manufacturing Implementation

    … not viewed by management as being a viable area for gaining a competitive edge.  Indeed, due to shrinking profit margins and increasing cost pressures, companies are increasingly outsourcing their production overseas where costs are lower.  Pharmaceutical executives are reducing the task of cutting costs to a simplistic equation, and outsourcing decisions are often made on nothing more than a comparison between the cost of production at the company’s facility versus the cost of …

  • Pharmaceutical Consulting Firms: Hero or Hype?

    … prescription benefits, and managing inpatient medications, as well as managing related costs such as those connected with radiology. Many consulting firms do specialize, though, and the area of specialty usually falls at one end of the services spectrum or the other – for instance, either the R&D/manufacturing/distribution end or the patient/healthcare-facility/healthcare-provider end. For example, one of the specialized offerings of some pharmaceutical consultants is specialty drug …

  • The Drive Behind Lean Manufacturing Implementation

    … the rise. In 2005, the FDA fined GlaxoSmithKline $650 million due to irregularities at a production facility in Puerto Rico. · Fewer block-buster drugs are being produced. Consequently, it’s increasingly difficult to justify the burgeoning costs of drug development and to gain investors for future development. With all these hurdles reducing profitability, pharmaceutical executives are now actively seeking to remodel production and boost efficiency. The first issue to receive consideration …

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

    … -Laboratory certification documents -Drug accountability records -Each subject’s signed informed consent -Assess support areas, like pharmacy or lab, to make sure they are properly prepared.  The FDA may tour the facility Be ready to answer these questions: –    Where was the study done? –    What special equipment was used? –    Who assisted in doing the study? –    What were each person’s specific responsibilities? –    Describe the …

  • How to Get Through a Successful Pre-Approval Inspection

    … commitments to ensure the authenticity and accuracy of any data contained in your company’s submitted application file.  It is the inspector’s job to thoroughly inspect your facility, as well as any records or data you have available, to make sure that your site produces reliable data information, and that all key GMP systems are up to code with current GMP standards. Thorough preparation work is absolutely paramount when ensuring that your company is successful in getting through …

  • Novel Stem Cell Technology for Bone Fractures Developed

    … different interested parties joined forces to establish a clinical-grade protocol for the use of immuno-isolated MSC’s. The head of orthopedics at Hadassah University Hospital, the Good Manufacturing Practice facility at Hadassah, and the Gazit group at the Faculty of Dental Medicine, conducted a clinical trial in order to establish the foundation for the use of immuno-isolated MSC’s in orthopedic surgery. Seven patients have benefited so far from the treatment of combining their own …

  • Be Prepared When the FDA Knocks on Your Door

    … way to ensure a successful FDA inspection is to ensure the facility complies with FDA regulations.  Every employee must be aware of the products and processes’ FDA standards for the area he or she tends to.  Employees have to be trained to stay calm, be respectful, and follow the FDA official’s requests, as well as to know their rights about what they have, or not have, to say or show the FDA. 2.    Identify and work on weaknesses Smart professionals work on identifying the weaknesses …

  • Ensuring QC for Laboratory Operations

    … to drug development processes. There are regulations to ensure that the products comply with certain standards of safety, efficacy, purity, and stability.  These regulatory inspections are conducted anytime, without warning by the FDA, thus, laboratories must perform regular self-evaluations to ensure they meet the regulatory standards. Following are several basic elements of a laboratory control system that ensure the production of high-quality products: 1.    The facility It should be of  …

  • Creation of a Winning Business Plan

    … facility, and what are your plans for keeping it productive and controlling costs?  What qualifications and standards must you meet in order to be able to release product, and how long will it take? A Go-to-Market plan is essential to any complete business plan, and details your strategy for receiving market focus and actually selling your product.  Here, you should describe your Marcom plan as well as your sales channel plan.  Without a plan to reach actual customers, no product can be …

  • Disposable Components In Bioprocessing Production Lines

    … facilities will be strategically placed so as to allow multiple configurations of storage tanks, reactors, filters, hoses and other common components. The time it will take for a bioprocessing facility to switch from one product to another or from one batch volume to a larger or smaller one, will become shorter and shorter as more disposable components become available. Indeed it seems disposables are here to stay. If you enjoyed this article, please feel free to post it to your site or blog and …

  • What If You Fail The FDA Pre Approval Inspection?

    … or individual increases dramatically. Apart from being terribly disruptive to the company, it has a negative impact on your workers’ morale. DELAY IN APPROVAL FOR PRODUCTS NOT YET MARKETED: If the FDA considers your facility at fault, they will not approve any pending NDAs. The argument is simple: faulty cGMPs. IMPACT ON ONGOING RESEARCH: As in the case of clinical research under IND exemption, and especially when manufacture or clinical testing has been performed in the same facility of the …