Formulation and Quality – Chemical
2019 PharmSci 360
The talk will address key strategies to be taken for implementing ICH Q12 based change management. ICH Q12 underlines the success of regulatory authority collaboration. The efforts show that the ccommunication between regulators has started. As an organization, it is high time to ask whether we are ready for this change. The guidance is under consultation while harmonization efforts are ongoing. The life cycle guidances such as quality risk management (QRM), quality by design (QbD) approach, and pharmaceutical quality system (PQS) are well established in the industry. Now it is up to each one of us to regularize use of the post approval change management protocol for the benefit of patients, organizations, and regulators.