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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. 

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.

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

  • Quality Control/Quality Assurance
  • Regulatory Affairs

Todd Graham is a Masters-level Bench Scientist and Medical Technologist with a host of experience in both the clinical diagnostics and biotechnology fields. Mr. Graham has worked for a number of start-up firms in the clinical diagnostics and biotechnology industries, as well as worked for larger firms within both industries.

Todd has a broad level of expertise in assay development for quality control, pharmaceutical development, and clinical diagnostics. His particular levels of expertise are molecular diagnostics, PCR, ELISA, quality control and training of bench level personnel in clinical diagnostics and biotechnology. He is also in the process of establishing a consultancy that assists academic labs in transitioning their research to industry by verifying and improving the quality of their work.

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