Self-inspection
Article 9
1. Regular self-inspections shall be conducted to monitor the implementation of the arrangements regarding personnel, premises, equipment, documentation, production, quality control, quality management system, batch release and arrangements to deal with quality-related complaints and recalls. 2. The self-inspections shall verify the suitability of arrangements referred to in paragraph 1, ensuring that the active substances meet the required quality standards and comply with good manufacturing practice. 3. Self-inspections shall be recorded. Reports shall include the observations made and, where applicable, proposals for corrective measures. The actions subsequently taken shall also be recorded.