Tag Archives: recall

  • 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 …

  • Lean Manufacturing Solves Drug Recalls and Bad Press

    … incidents: 9 October 2010 – Reports of an uncharacteristic odor prompted Pfizer to recall the 40-mg bottles of LIPITOR. (fda.gov) 8 October 2010 – FDA pressure led Abbot Laboratories, the manufacturer of Merida (sibutramine), to recall the drug in the US, Canada, and Australia due to the possibility of cardiovascular events after long-term use. (drugrecalls.com) 7 October 2010 – FDA violations of its anti-aromatase ingredient resulted in Gaspari Nutrition recalling all …

  • Pharmaceutical Consulting and BMI’s 4th Quarter Update

    … Additionally, developments in the third quarter of 2010 will almost certainly result in even heavier compliance and regulatory burdens for drug manufacturers, especially with respect to the OTC segment. The events included the recall of 21 lots of medications – among them certain Tylenol products, as well as Benadryl and Motrin – by Johnson & Johnson. In addition, the FDA recently initiated a new program that will make the safety evaluations for recently approved drugs and …

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

    … of clinical studies outside of your specialization field _ The reporting of much better effectiveness, less unfavorable effects, or different laboratory results from other sites studying the same drug _ Having noticeable access to a large number of patients with a specific disease state for the setting _ Complaints from a patient or sponsor in regards to regulations, protocol, or human rights violations -Customer complaints that may trigger a product recall How it all starts It all starts with a …

  • Lean Analysis and Optimization for Pharmaceutical and Biopharmaceutical Manufacturing

    … First-pass yields increase Throughput increase Productivity increase In the pharmaceutical and biopharmaceutical environment, where the risk of contamination or product recall must be eliminated or face extremely high costs and liabilities, an added benefit of lean analysis is the elimination of information waste. Information systems are of great importance in building quality systems and ensuring compliance. …