Excipients related – Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

1 minute read Uncategorized

Updated on September 16, 2025

Updated on September 16, 2025

Excipient Risk Assessment (Europe): Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use ( EC 2015/C 95/02)
PIC/S Document: Guidelines On The Formalised Risk Assessment For Ascertaining The Appropriate Good Manufacturing Practice For Excipients Of Medicinal Products For Human Use
EMA: Guideline On Excipients In The Dossier For Application For Marketing Authorisation Of A Medicinal Product

IPEC Europe (International Pharmaceutical Excipients Council Europe)- How to do document on European Commission Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients (version 5, 2022). IPEC Guidelines
IPEC Europe (International Pharmaceutical Excipients Council Europe) – Resources (on Pharmaceutical Excipients)
IPEC: Technically Unavoidable Particle Profile (TUPP) Guide – Version 2 (2024)
USFDA Using the Inactive Ingredient Database (IID) Guidance for Industry; FDA Guidance; Search the IID
WHO Good Manufacturing Practices for Excipients Used in Pharmaceutical Products (TRS 1060 – Annex 3)

Tags : Excipients

Share: