Assign risk category for source risk elements. Move the cursor over each Element for guidance on assigning the risk level
| Element |
Risk Level |
Rationale |
|
TSE / BSE Risk
Low: Not of animal origin or Animal origin but no TSE / BSE risk (e.g. milk-based); Medium: Animal origin but not bovine, or high-risk tissues; High: From bovine / other animals with high TSE / BSE risk, high risk tissues like brain, spinal cord etc.
|
|
|
|
Viral Safety Risk
Low: No Animal or Human source or Animal origin but no Viral safety risk (e.g. milk-based); Medium: Animal source but not from cell lines / organs / tissues, Have effective controls for viral contaminants like heat treatment, pasteurisation etc; High: Derived from cell lines / organs / tissues of animal or human source, blood / urine or biological fluids
|
|
|
|
Microbiological Contamination Risk
Low: Not of animal or plant origin, Synthetic/mineral origin, non- nutrient source for microbial growth; Medium: Not of animal or plant origin, Synthetic/mineral origin but can be nutrient source for microbial growth High: Animal / plant origin, can be nutrient source for microbial growth, High water activity
|
|
|
|
Aflatoxin / Pesticide Risk
Low: Not vegetable origin, not prone to aflatoxins / pesticides; High: Vegetable origin with no controls for aflatoxins, pesticide residues in raw materials
|
|
|
|
Process Impurities Risk
Low: No solvents/catalysts involved in manufacturing process; Medium: Manufacturing process involves solvents / catalysts, risk assessment or specification controls in place for process impurities High: No risk assessment or specification controls for process impurities
|
|
|
|
Sterility Risk
Low: Excipients for non-sterile products, non-sterile excipients; High: Excipients for sterile products, sterile excipients
|
|
|
|
Contamination Risk (Equipment)
Low: Dedicated facility / equipment; Medium: Multiproduct facility, risk assessment /cleaning validations in place High: Multi product facility, cleaning practices in adequate, no cleaning validation
|
|
|
|
Nitrosamines Risk
Low: No solvents / reagents with risk of nitrosamines, nitrosation; Medium: Excipient process has nitrosation reaction / reagents and amines / amine contributing reagents in different steps High: Excipient process has nitrosation reaction / reagents and amines / amine contributing reagents in same steps
|
|
|
|
Stability Risk
Low: Stable excipient; High: Excipient not known to be highly stable / No formal stability data
|
|
|
|
Storage Conditions Risk
Low: No specific storage / transport temperature conditions for excipient; High: Excipient requiring controlled temperature or cold chain transport
|
|
|
|
Supply Chain Complexity
Low: Purchased directly from manufacturer, from regions with controls on security, no repackaging; Medium: Minimum intermediaries, contracts in place; High: many intermediaries, complex supply chain, regions with security concerns
|
|
|
|
Packaging Integrity Risk
Low: Low supply chain complexity, tamper-proof seals in place; High: poor tamper proof pack, seal integrity
|
|
|
|
Manufacturer Reliability Risk
Low: Established excipient manufacturer, good history of supplies; Medium: Minimal experience with manufacturer / some quality or performance issues; High: History of quality failures, excipient variability
|
|
|