Contents
- 1. Marketing authorisation holders shall establish and implem…
- 2. The quality management system shall be described in the ph…
- 3. Marketing authorisation holders shall ensure that the qual…
- 4. Marketing authorisation holders shall ensure that the qual…
- 5. Marketing authorisation holders shall ensure that the qual…
- 6. Marketing authorisation holders shall ensure that the qual…
- 7. Marketing authorisation holders shall clearly define the r…
- 8. Marketing authorisation holders shall set up a quality man…
3.Marketing authorisation holders shall ensure that the quality management system includes detailed policies, processes and procedures on document management, training, audits, and change management covering the activities in accordance with Articles 5 to 9. Those policies, processes and procedures shall provide for a review of the quality management system at regular risk-based intervals, based on pre-defined criteria.
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