Nitrosamines – Qvents

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Updated on October 11, 2023

Updated on October 11, 2023

USFDA: Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs; Updated 2/24/21
USFDA Updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products
USP General Chapter <1469> Nitrosamine Impurities – Presentation; (Also Refer USP General Chapter)
EMA (European Medicines Agency) Nitrosamine impurities
EMA Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
EMA Guidance for marketing authorisation holders
EMA Active substance-derived nitrosamines
CMDh Information On Nitrosamines For Marketing Authorisation Holders
EMA (Adopted by CHMP) Assessment report Nitrosamine impurities in human medicinal products
European Pharmacopeia General Monographs : Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619) for Ph. Eur. approach to N-nitrosamine impurities (Access through Ph Eur (EP)
APIC (CEFIC) Additional guidance on the assessment on the risk assessment for presence of N-nitrosamines in APIs
APIC (CEFIC) Template for Nitrosamine Risk evaluation of APIs
IPEC Europe: Questionnaire for Excipient Nitrosamines Risk Evaluation
IPEC Americas: Federation Announces Updated Nitrosamines Questionnaire
WHO Information Note Nitrosamine impurities
Health Canada Nitrosamine impurities in medications: Guidance

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