By Robert Iser, Vice President, PAREXEL Consulting
Following the ICH meeting in November 2017, ICH published the long-sought after Q12 guideline titled Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management [ICH webpage link, http://www.ich.org/products/open-consultation.html]. Soon the guideline will be available for public comment in the ICH member regions. The draft guideline lays out the key areas to be considered and tools that may be used to more effectively and efficiently manage drug and biologic products throughout the lifecycle, and tying to other current ICH quality guidelines (including Q8, Q9, Q10 and Q11).
Managing a product over its lifecycle requires a robust Pharmaceutical Quality System (Q10); use of Quality Risk Management approaches to develop and maintain product quality (Q9); and designing quality into APIs and drug products using science and risk based development approaches (Q8 and Q11). ICH Q12 ties all these quality guidelines together and adds best practices from throughout the world (e.g., risk-based categorization of changes, identifying established conditions, lifecycle change management summaries, effective change management principles, and options for currently marketed products) to provide an important guide to companies managing changes to approved products and submitting regulatory dossiers to health authorities.
PAREXEL Consulting’s global cadre of subject-matter experts can provide crucial advice to companies developing products and preparing regulatory submissions leveraging the lifecycle management tenets found in ICH Q12 and the other ICH quality guidelines. PAREXEL currently supports numerous clients in developing and implementing regulatory and compliance strategies to support submissions of new drug, biologic and generic products throughout the world.