2003N-0059 - Pharmaceutical Current Good Manufacturing Practices for the 21st Century: A Risk-Based Approach
  


  

  
FDA Comment Number : 
  

  
EC34
  



  

  

  



  

  
Submitter : 
  

  
Mr. Dennis Tajiri
  

  
Date & Time: 
  

  
06/17/2003 10:06:22
  



  

  
Organization : 
  

  
Mr. Dennis Tajiri
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Risk Management Automated Enterprise Software solution:



I have performed risk assessments for companies that have responded to FDA 483s for Computer Systems.  The format of the risk assessment was comprehensive for production automated systems.  Various aspects of risks surrounding the manufacturing environment were assessed and a subjective ranking system was used to poll various members of the risk assessment team.  The team was composed of the facilitor, QA, Engineering, Calibration, Maintenance, Operations, and validation.  Incorporated in the risk assessment were business risks, physical safety to machine and operators, product quality, failures both in operations and in defect detection, if applicable, labeling errors, etc.



From this experience, I have been working with several software firms to automate this process.  It would be more of an enterprise solution and encompass a wider part of the organization than just operations.  The software as currently conceived would include but not be limited to operations, drug development, process development, process analytics, clinical development, discrepancy management, quarantined products and raw materials, validation, process validation, regulatory compliance, quality management, audits, recalls, and other key aspects involving risk management and analysis.  The software would have the abilty to rank risk by frequency and probability using mathematical models and statistical simulation tools.  If a moderate or high risk is detected, an email alert will be sent automatically to notify the responsible party.  This is part of the risk management tool for mitigating high risks.



We are looking for a forward thinking company that would like to fund the development of such an enterprise solution and tailor make the software to fit your organization's needs and priortities.  Feel free to contact me, Dennis Tajiri, dtajiri@mindspring.com, or by cell phone 707-803-2071 to discuss this in greater detail.



The future is now!!