CMC Change Impact Assessment Template (CTD Module 3)
3 200 SEK
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Purpose:
Provides a structured framework to assess and document the potential impact of chemistry, manufacturing, and control (CMC) changes on CTD Module 3 content to support controlled change management activities.
Regulatory Alignment:
Aligned with EU GMP expectations for change control and lifecycle management, including ICH Q10 (Pharmaceutical Quality System) and ICH Q12 (Pharmaceutical Product Lifecycle Management).
Included Files:
• CMC change impact assessment template
• CTD Module 3 impact mapping table
• Guidance fields to support consistent evaluation and documentation
Format:
Microsoft Word or Microsoft Excel (fully editable)
Intended Users:
Pharmaceutical manufacturers, regulatory affairs, quality assurance teams, and technical functions responsible for GMP change control and CMC impact assessment.