Cleaning Validation – Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

1 minute read Uncategorized

Updated on October 11, 2023

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)
WHO TRS 1033 – Annex 2: Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation

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