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Cleaning Validation
Qvents
1 minute read
Uncategorized
Home
Guidelines
Cleaning Validation
Updated on October 11, 2023
Home
Guidelines
Cleaning Validation
Updated on October 11, 2023
APIC
(Active Pharmaceutical Ingredients Committee):
Guidance On Aspects Of Cleaning Validation In Active Pharmaceutical Ingredient Plants
European Medicines Agency (EMA)
:
Guideline on setting health based exposure limits; Questions and answers on Guideline on setting health-based exposure limits
USFDA
Guide To Inspections :
Validation Of Cleaning Processes
PIC/S
:
Guideline On Setting Health Based Exposure Limits For Use In Risk Identification In The Manufacture Of Different Medicinal Products In Shared Facilities (PI 046-1 Annex 1 July 2018)
TGA
:
Cleaning Validation – A regulatory perspective (Presentation)Â
WHO TRS 1033 – Annex 2
:
Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation
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