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SOP 1 Quality Manual
SOP 2 System for SOPs
SOP 3 Organization and Training
SOP 4 Vendor selection and management incl. sponsor oversight
SOP 5 Risk evaluations and management
SOP 6 Archiving
SOP 7 Recall
SOP 8 Product complaints
SOP 9 Pharmacovigilance
SOP 10 Monitoring of new regulations
SOP 11 Change Control
SOP 12 CAPA (Corrective and Preventive Actions)
SOP 13 Serious Breach
SOP-14: Prevention and Management of Counterfeit Medicines
SOP-15: Date Format and Rounding Rules
SOP-16: Inspections from Authorities and Partners
SOP-17: Raw Data and Good Documentation Practice
SOP-18: Responsibility and Organization of Operational and Quality Areas
SOP-19: Return and Destruction of Medical Products
SOP-20: Release of Products with Marketing Authorisation Manufactured at CMO
SOP-21: Final Product Item Number
SOP-22: Use of CMO Batch and Item Number Systems
SOP-23: Investigation of Out of Specification (OOS) Analysis Results
SOP-24 Quality Measurements
