IPEC Risk Assessment Guide – ToC

Version 1 - 2025

Table of contents – General availability: 6 August 2025

IPEC Quality-by-Design Guide

Version 2 - 2025

IPEC Good Distribution Practices Guide (GDP)

Version 3 - 2024

IPEC Certificate of Analysis (CoA) Guide

Version 2.1 - 2024

IPEC Quality Agreement – Guide

Version 3 - 2024

IPEC Quality Agreement – Templates

Version 3 - 2024

QA Template(s) – Word document
Manufacturer’s Quality Statement – Responsibility Table – Distributor’s Template – Responsibility Table – Manufacturer’s Template

IPEC Technically Unavoidable Particle Profile (TUPP) Guide

Version 2 - 2024

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-PQG Good Manufacturing Practices Guide

Version 5 - 2022

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 GMP Certification Scheme and CB Qualification Guide

Version 1 - 2020

Download the Template here

IPEC Excipient Composition Guide

Version 2 - 2020

PDA-IPEC Technical Report 54.6 Formalized Risk Assessment for Excipients

Version 1 - 2019

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