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      • R-023-001_001 Change control
      • R-023-001_002 Change control
      • R-023-001_003 Change control
      • R-023-001_004 Change control
      • R-023-001_005 Change control
      • R-023-001_006 Change control
      • R-023-001_007 Change control
      • R-023-001_008 Change control
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  • GP-023 Change control management
  • R-023-001_007 Change control

R-023-001_007 Change control

DRAFT

This change control record is pending implementation.

Description​

  • Change name: Change of AEMPS Technical Responsible
  • Change description: Change of the Technical Responsible registered with AEMPS (Spanish Agency for Medicines and Medical Devices) from Alfonso Medela to Taig Mac Carthy. This involves updating the AEMPS manufacturer license to reflect the new Technical Responsible and ensuring compliance with Spanish national requirements.
  • Source of change: Internal organizational change and regulatory compliance with Spanish national requirements.

Impact analysis​

  • Regulatory impact: is the change classified as significant?
    • Yes (it requires notification to Regulatory Authorities): AEMPS was notified to update the manufacturer license with the new Technical Responsible.
    • No (it does not require notification to Regulatory Authorities)
  • Risk analysis impact: No impact on risk analysis. The new Technical Responsible meets all qualification requirements established by AEMPS.
  • Quality documentation impact:
    • AEMPS manufacturer license - Updated with new Technical Responsible
    • Quality manual (organizational structure section)
    • Annex 2 - Organizational chart
    • Technical Responsible qualification evidence
    • AEMPS notification and approval documentation

Approval​

The change is pending approval.

Plan​

  • Submit notification to AEMPS for change of Technical Responsible.
  • Update AEMPS manufacturer license with new Technical Responsible information.
  • Update the organizational chart in Annex 2.
  • Update the Quality manual organizational structure section.
  • Document Technical Responsible qualification evidence per AEMPS requirements.
  • Archive AEMPS approval documentation.

Implementation​

Implementation date: TBD (pending AEMPS approval)

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
  • Approver: JD-001 General Manager
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R-023-001_006 Change control
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R-023-001_008 Change control
  • Description
  • Impact analysis
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  • Plan
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