Now Available - IQ Change Management in Development White Paper

August 9, 2016

Change management in the clinical development phase is fundamentally different from change control in commercial manufacturing.  During development, product and process understanding is still evolving and changes occur frequently.  The ICH Q10 guideline recognizes that “There is generally a difference in formality of change management processes prior to the initial regulatory submission and after submission”.  The ICH Q10 guideline also states that “Change is an inherent part of the development process and should be documented; the formality of the change management process should be consistent with the stage of pharmaceutical development”.  

The goal of this white paper is to create a better understanding of how to implement a change management system in the clinical development phase of a product’s lifecycle including the appropriate level of oversight for change management activities at CMOs.  This white paper:
•    describes the regulatory requirements for a change management system
•    provides a summary of a brief survey to establish a baseline for current change management practices within the IQ member companies
•    describes the key elements of a change management system
•    describes effective oversight of change management at CROs/CMOs
•    provides final conclusions