Guidelines - IPEC Federation

IPEC Quality Agreement Guide and Templates(s) – ToC

Version 3 - 2024

General availability on 20 May.

Technically Unavoidable Particle Profile (TUPP) Guide – ToC

Version 2 - 2024

General availability on 5 May.

IPEC General Glossary of Terms and Acronyms

Version 3 - 2023

IPEC Significant Change Guide

Version 5 - 2023

IPEC Excipient Information Package User Guide – Sustainability

Version 1 - 2023

Part 4 – Sustainability Overview

IPEC Excipient Stability Guide

Version 2 - 2022

IPEC Certificate of Analysis (CoA) Guide

Version 2 - 2022

IPEC-PQG Good Manufacturing Practices Guide

Version 5 - 2022

IPEC Safety Guide

IPEC Safety Guide

Version 1 - 2021

IPEC Good Distribution Practices (GDP) Audit Guide

Version 3 - 2021

IPEC Validation Guide

Version 1 - 2021

IPEC Excipient Information Package User Guide

Version 4 - 2020

IPEC Excipient Information Package Templates

Version 4 - 2020

IPEC Qualification of Excipients Guide

Version 2 - 2020

IPEC Good Distribution Practices Guide

Version 2 - 2017

IPEC GMP Certification Scheme and CB Qualification Guide

Version 1 - 2020

Download the Template here

IPEC Quality-by-Design Guide

Version 1 - 2020

PDA-IPEC Technical Report 54.6 Formalized Risk Assessment for Excipients

Version 1 - 2019

Purchase the document: https://techpubportal.pda.org/

IPEC Excipient Composition Guide

Version 2 - 2020

IPEC Quality Agreement Guide and Template(s)

Version 2 - 2017

QA Responsibility Table – Distributor’s Template

Version 2 - 2017

QA Responsibility Table – Manufacturer’s Template

Version 2 - 2017

QA – Manufacturer’s Quality Statement

Version 2 - 2017

Guides in other languages

Good Distribution Practices – Spanish version

Version 2 - 2017

The guide was translated by SAFYBI.