BACKGROUND. • The International Council on Harmonisation (ICH) “Q8(R2) Pharmaceutical. Development,” published November 20, 2009, provides information on how to present knowledge gained when applying scientific approaches and quality risk management for developing and manufacturing a product.

What is ICH Q8 guidelines?

The ICH Q8 guideline is (…) is intended to provide guidance on thecontents of Section 3.2. P. 2 (Pharmaceutical Development) for drug productsas defined in the scope of Module 3 of the Common Technical Document (ICHtopic M4).

What is ICH Q8 Q9 Q10?

ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy. This information can be used to identify the type and focus of studies to be performed prior to and on initial commercial production batches.