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- Title
Points to consider on the different approaches -- including HBEL -- to establish carryover limits in cleaning validation for identification of contamination risks when manufacturing in shared facilities.
- Authors
Gigante, Valeria
- Abstract
The article discusses the points to consider on the different approaches including Health-Based Exposure Limits to establish carryover limits in cleaning validation for identification of contamination risks when manufacturing in shared facilities. Topics include discuss the different possible approaches – including methods that account for pharmacological and toxicological data; and clarification on cleaning validation and approaches to cleaning validation in multiproduct facilities.
- Subjects
CLEANING compounds; DOCUMENTATION; DRUG adulteration; DOSAGE forms of drugs; PHARMACEUTICAL industry; QUALITY assurance; RISK assessment; RISK management in business; MANUFACTURING industries; EQUIPMENT maintenance &; repair
- Publication
WHO Drug Information, 2020, Vol 34, Issue 2, p146
- ISSN
1010-9609
- Publication type
Article