ICH Q10, The Pharmaceutical Quality System – Bring the Pharmaceutical Industry Into the 20st Century

ICH  Q10  describes  one  comprehensive  model  for  an  effective  pharmaceutical  quality  system that is based on International Standards Organisation (ISO) quality concepts, includes applicable Good Manufacturing Practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management”. ICH Q10  is  a  model  for  a  pharmaceutical  quality  system  that  can  be  implemented  throughout the different stages of a product lifecycle. Much of the content of ICH Q10 applicable    to    manufacturing    sites    is    currently    specified    by    regional    GMP    requirements. ICH Q10 is not intended to create any new expectations beyond current regulatory  requirements.  Consequently,  the  content  of  ICH  Q10  that  is  additional  to  current regional GMP requirements is optional. ICH  Q10  demonstrates  industry  and  regulatory  authorities’  support  of  an  effective  pharmaceutical  quality  system  to  enhance  the  quality  and  availability  of  medicines  around  the  world  in  the  interest  of  public  health.  Implementation  of  ICH  Q10  throughout    the    product    lifecycle    should    facilitate    innovation    and    continual improvement  and  strengthen  the  link  between  pharmaceutical  development  and  manufacturing activities. 

• Objectives of ICH Q10
• Enablers of ICH Q10
• Management responsibilities
• Life Cycle Management
• Pharmaceutical Quality System Management
• Continuous Improvement of the Quality System

When marketing products all over the world, there will be a need to deal with the regulatory systems of various nations.  The ICH Q10 rules are an effort to minimize the differences between these regulatory systems to simplify the submission process.  Aligning your quality system with these rules will make life easier.  You can ensure that the information that your company has on the development process can be used in multiple contexts without the need to reformat information or perform additional work.

• Quality Control/Quality Assurance
• Regulatory Affairs

Todd Graham is a clinical laboratory scientist for a large hospital system in the New York Tri-State Area, as well as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world, and R1 Research Level Universities. During his time as a clinical laboratory scientist in his current role, Todd has improved sample workflow and improved laboratory quality and sample turnaround time while expanding laboratory services to vulnerable health populations in the New York area. He has also provided outreach to the local community by serving as a mentor to students training in clinical laboratory science, as well as the scientific community by serving as a technical resource for his peers in the laboratory.

Through his work as a consultant, he has worked to improve the spread of key technical information in a variety of mediums. He has written several market research reports used by Fortune 500 biotechnology firms in strategic planning and led webinars on key quality issues that impact the biotechnology community. He has served R1 Research Level Universities by advising them on strategic technology transfer opportunities and has been called upon as a key knowledge leader internationally for the biotechnology industry.

Todd graduated in 2006 with an M.A. in Biology at Queens College (City University of New York) after conducting published research in Molecular Evolution in the laboratory of Dr. Stephane Boissinot. He graduated as a Dean’s List student and James Dickson Carr Scholar from Rutgers University in 2001 with a BS in Biotechnology, where he continues to mentor Biotechnology students. He is a member of the Society for Laboratory Automation and Screening. He is also licensed as a Clinical Laboratory Technologist in New York State and is certified in Molecular Diagnostics by the American Society for Clinical Pathology.