Discussion forum for Pharma Quality events, Regulatory Actions

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

FDA updates guidance for Reconsideration

This guidance provides procedures for ANDA applicants who wish to pursue a request for reconsideration

Qvents
January 11, 2024

FDA revise Quality guidance for Ophthalm

FDA has published a revised guidance on quality considerations for topical ophthalmic drug products –

Qvents
December 29, 2023

Ph.Eur pre-publishes revised monograph f

The revised monograph for Propylene Glycol (PG) includes test for Ethylene Glycol (EG) and Diethylene

Qvents
December 11, 2023

Nitrosamines, NDSRIs and Predicting carc

USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry

Qvents
August 9, 2023

EMA Updates Nitrosamines Q&A documen

EMA updates Q&A document on N-Nitrosamines. In the Rev 16 (dated 7 July 2023) limits

Qvents
July 19, 2023

USFDA Implements ICH Q9(R1)

USFDA announced implementation of the ICH Q9(R1) guideline Quality Risk Management. Earlier ICH had adopted the Revision

Qvents
May 22, 2023

USFDA has issued a new
Qvents
May 11, 2023

IPEC issues Questionnaire for Excipient

IPEC Federation announced the availability of the “Questionnaire for Excipient Nitrosamines Risk Evaluation” (version 1,

Qvents
February 27, 2023