Excipients related – Qvents

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Updated on April 21, 2025

Updated on April 21, 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 Americas (International Pharmaceutical Excipients Council Europe) –Document Depot (For several resources on Excipients (Standards, Test Methods, Discussion papers).
IPEC Americas – S. Drug Master File Guide For Pharmaceutical Excipients (Download from Document Depot)
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)

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