At its meeting in Seville in November 2011, the ICH Quality Implementation Working Group finalised three Points to Consider topics covering: Role of Models in Quality by Design (QbD); Design Space; and Process Validation/Continuous Process Verification. The three topics were added to the three existing Points to Consider topics which were released in June 2011. This additional material, relevant to the implementation of ICH Q8(R2), Q9 and Q10, further complements the existing Questions & Answers and workshop training materials already produced by this group.
The ‘Points to Consider’ are based on questions raised during the ICH Q-IWG training workshop sessions in the three regions. They are not intended to be new guidelines but rather to provide clarity to both industry and regulators and to facilitate the preparation, assessment and inspection related to applications filed for marketing authorizations.
The development approach should be adapted based on the complexity and specificity of product and process; therefore, applicants are encouraged to contact regulatory authorities regarding questions related to specific information to be included in their application.
Using the Quality by Design (QbD) approach does not change regional regulatory requirements but can provide opportunities for more flexible approaches to meet them. In all cases, GMP compliance is expected
The updated Points to Consider document is available here
Source: Press Release ICH