Tag Archives: investigation

  • SCG’s thoughts on the last 10%

    For the Pharmaceutical industry, it is difficult for consumers to tell the difference between an excellent, acceptable or poor quality product.  For this reason, safety, quality and reliability problems can go undetected  until the FDA detects them during an inspection or after investigation for a product recall.  By then, the problems can be out of control and can result in a Warning Letter or Consent Decree. The below excerpt can be found here: “ // // Seth’s Blog: The …

  • The Battle Brewing Over Vaccinations

    A recent CDC investigation shows that a measles outbreak in southern San Diego was caused by parents refusing to have their children vaccinated, even though it is required in many states by law.  Because measles is one of the world’s most highly contagious diseases, this new trend of refusing vaccinations is becoming more and more alarming to the CDC who fears a new, more powerful measles outbreak could be looming.  But how could this be?  Many are blaming ever increasing worry and …

  • Compliance Tips For cGMP Inspections

    … inspection audit, and what do you do if they show up one afternoon at your front door? The FDA inspector must present some form of notice of inspection (FD-482), and should offer proper FDA credentials upon your company’s request.  If the FDA inspector cannot supply you with the proper credentials, then it is within your company’s legal right to not begin the investigation until the person can authenticate their FDA status.  Any persons accompanying the investigator should be able …

  • How to Prepare for the New Structure for Approval of Follow-on Biologics

    … and if you own or license-in the technology involved.  In addition, ask for legal counsel and pharmaceutical consultancy to start a full due diligence investigation so that you are ready to identify the patents that cover your biological product. 2.    Understand your product and manufacturing processes Get your scientists and manufacturing engineers on board and check everything about your product and its creation process, to acknowledge if a generic manufacturer could create something …

  • What If You Fail The FDA Pre Approval Inspection?

    … services to any company with a pending or approved NDA or ANDA. In fact, any company submitting an NDA or ANDA to the FDA must first certify that no debarred individuals participated in their application process. CRIMINAL investigation: The Department’s criminal investigative powers are the most significant consequence of not passing the inspection. Once the FDA starts thinking that there may be some fraud associated with your NDA submission, your exposure to criminal prosecution as a company …

  • Lean Analysis and Optimization for Pharmaceutical and Biopharmaceutical Manufacturing

    … First, processes need to be defined as value-adding or non value-adding. investigation is then conducted to find out why it does not add value and whether it can be modified or substituted to add value. In this way, process by process, a streamlining of the manufacturing flow takes place, and control systems to ensure efficiency are installed. Typical benefits of lean analysis are: Manufacturing cycle time reduction Lead time reduction Floor space requirement reduction Work-in-process reduction …

  • Lean Operational Compliance in the New Pharmaceutical Industry Environment

    … they’ve been doing business for the past decades and move toward waste reduction, inventory reduction, higher capacity utilization,  higher productivity and attempt to achieve the goals of zero lost information, zero defects, zero bureaucracy, zero misalignment, and zero lost opportunities. The focus of lean systems is to eliminate waste and reduce processes to their most streamlined and value-adding expressions. The same definition of such processes, their investigation and streamlining to …

  • Risk analysis and Quality Systems in Development of LEAN Compliance Systems in Pharmaceutical Development and Manufacturing

    … misalignment, team based operations, zero lost information, zero defects and zero waste of creativity in quality control systems. The risk is then controlled by installing quality systems within the process and doing away with the end-process testing view of quality and compliance. Risk analysis and quality system analysis then go hand-in-hand when defining the elements of the development and manufacturing process, the investigation of each element, the streamlining process and the controls set …

  • Congress Oversight Of Pharmaceutical Industry

    … influence in the increase of safety concerns? Might Mr. Grassley have paid attention to and attempted to curtail a true phenomenon? The jury is out, and a lot more investigation is needed. In the meantime, it is said some FDA staff and many executives at major pharmaceutical companies are keeping their fingers crossed, as this could mean a break for them after five years of tough scrutiny. As they say, though, you must be careful what you wish for… there could always come a replacement with a …