Change Control

Change Control. No changes to approved processes, materials, equipment, specifications, manufacturing site, or testing methods shall be implemented without prior written approval through the formal change control process. The Party initiating a change shall submit a Change Control Request that includes: (a) a detailed description of the proposed change; (b) the rationale and justification for the change; (c) a risk assessment of the potential impact on product quality, safety, and efficacy; (d) a validation or qualification plan, if applicable; (e) a regulatory impact assessment identifying any required submissions or notifications to regulatory authorities; and (f) a proposed implementation timeline. Both Parties shall review and approve all Change Control Requests prior to implementation. Changes classified as major shall require regulatory approval before implementation. The Manufacturer shall maintain a complete change control log documenting all changes, their classification, approval dates, and implementation status.