Guidelines

IPEC Good Distribution Practices (GDP) Audit Guide – ToC

Version 3 – 2021

IPEC General Glossary of Terms and Acronyms – Updated

Version 2 – 2021

IPEC Validation Guide

Version 1 – 2021

IPEC Excipient Information Package
Templates

Version 4 – 2020

IPEC Excipient Information Package
User Guide

Version 4 – 2020

IPEC Qualification of Excipients Guide

Version 2 – 2020

IPEC-PQG Good Manufacturing Practices Guide

Version 4 – 2017

Read the Statement

IPEC Good Distribution Practices Guide

Version 2 – 2017

IPEC Excipient Composition Guide

Version 2 – 2020
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IPEC GMP Certification Scheme and CB Qualification Guide

Version 1 – 2020

IPEC Quality-by-Design Guide

Version 1 – 2020

PDA-IPEC Technical Report 54.6 – Table of Contents

Version 1 – 2019
Purchase the Report

Technically Unavoidable Particle Profile (TUPP) Guide

Version 2 – 2015

IPEC Significant Change Guide

Version 3 – 2014

IPEC Quality Agreement
Guide and Template(s)

Version 2 – 2017

QA Responsibility Table – Manufacturer’s Template

Version 2 – 2017

QA Responsibility Table – Distributor’s Template

Version 2 – 2017

QA – Manufacturer’s Quality Statement

Version 2 – 2017

Guides in other languages

Good Manufacturing Practices – French version

Version 2 – 2017

Good Distribution Practices – Spanish version

Version 2 – 2017
The guide was translated by SAFYBI.

Significant Change – Spanish version

Version 1 – 2014
The guide was translated by SAFYBI.