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.
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.