Establish and reassess HBELs
Establish HBELs for medicinal products and reassess supporting data periodically.
CV-REQ-000020
HBEL and cross-contamination: questions and answers§ Q1
SOURCE DOCUMENT / EMA
HBEL and cross-contamination: questions and answers
Questions and answers · EMA/CHMP/CVMP/SWP/246844/2018
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Published: 19 Apr 2018
References in this document
Qualify the HBEL assessor
HBEL development requires suitable toxicological and pharmacological expertise.
CV-REQ-000021
HBEL and cross-contamination: questions and answers§ Q4
Distinguish HBELs from cleaning alert limits
An HBEL is not automatically the operational cleaning limit.
CV-REQ-000022
HBEL and cross-contamination: questions and answers§ Q6
Justify the changeover control strategy
Reduced analytical testing requires robust justification, including visual-inspection capability.
CV-REQ-000023
HBEL and cross-contamination: questions and answers§ Q7–Q8