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- All activities and checks are recorded in standard operating procedures and working instructions.
- Processes are managed based on risk analyses and the recording of deviations.
- GDP validated sourcing processes are supported by available documentation:
- Certificate of Analysis (COA)
- Batch Release Certificate (BRC)
- Certificate of Origin (COO)
- Pedigree statement
- Material Safety Data Sheet (MSDS)
- Patient Information Leaflet (Pil)
- Summary of Product Characteristics (SPC)
- A network of qualified suppliers.
- High storage and transport standard.
- Support from a strong quality team.