Change management in the clinical development process is fundamentally different from change management in commercial manufacturing where clearly defined processes have been validated and submitted to regulatory authorities. 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”. However, in a recent survey of IQ member companies, 41% of the respondents said their companies do not differentiate change management by phase of development.
There is a need for additional guidance on when change should be captured within the normal development process (project meetings, development plan, etc) and when change should be documented within a formal change management system. The Change Management in Development working group plans to:
- Benchmark of IQ member companies on the current status of their change management system in Development.
- Recommendations for how to structure a change management system in the development phase of a product’s lifecycle;
- Recommendations for how to track change management requests;
- Recommendations for how to oversee change management at CMOs.