Establish and reassess HBELs
Establish HBELs for medicinal products and reassess supporting data periodically.
CV-REQ-000020
AUTHORITY / European Union
EMA
European Medicines Agency
Source documents
Connected references
Qualify the HBEL assessor
HBEL development requires suitable toxicological and pharmacological expertise.
CV-REQ-000021
Distinguish HBELs from cleaning alert limits
An HBEL is not automatically the operational cleaning limit.
CV-REQ-000022
Justify the changeover control strategy
Reduced analytical testing requires robust justification, including visual-inspection capability.
CV-REQ-000023