Guidance for Industry: Q8, Q9, and Q10 Questions and Answers. Appendix. Q and As from Training Sessions.

摘要

The ICH Quality Implementation Working Group (Q-IWG) has prepared this Points to Consider document covering topics relevant to the implementation of ICH Q8(R2), Q9, and Q10, which supplement the existing guidance Q8, Q9, and Q10 Questions & Answers and workshop training materials already produced by this group. They should be considered all together. The points to consider are based on questions raised during the ICH Q-IWG training workshop sessions in the three regions. The points to consider are not intended to be new guidance. They are intended 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, good manufacturing practice (GMP) compliance is expected.