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International Pharmaceutical Excipients Council – IPEC Federation

ABOUT US
- History
- Structure
- Board
- Members
Resources
News
Events
Contact
My Fed

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Guidelines

IPEC General Glossary of Terms and Acronyms – Updated

Version 2 – 2021

IPEC Validation Guide

Version 1 – 2021

IPEC Qualification of Excipients Guide

Version 2 – 2020

IPEC Excipient Information Package
Templates

Version 4 – 2020

IPEC Excipient Information Package
User Guide

Version 4 – 2020

IPEC GMP Certification Scheme and CB Qualification Guide

Version 1 – 2020

IPEC-PQG Good Manufacturing Practices Guide

Version 4 – 2017

Read the Statement

IPEC Excipient Composition Guide

Version 2 – 2020
.

IPEC Quality-by-Design Guide

Version 1 – 2020

IPEC Good Distribution Practices Guide

Version 2 – 2017

Technically Unavoidable Particle Profile (TUPP) Guide

Version 2 – 2015

PDA-IPEC Technical Report 54.6 – Table of Contents

Version 1 – 2019
Purchase the Report

IPEC Quality Agreement
Guide and Template(s)

Version 2 – 2017

IPEC Significant Change Guide

Version 3 – 2014

QA – Manufacturer’s Quality Statement

Version 2 – 2017

QA Responsibility Table – Manufacturer’s Template

Version 2 – 2017

QA Responsibility Table – Distributor’s Template

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.

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Guidelines

IPEC General Glossary of Terms and Acronyms – Updated

IPEC Validation Guide

IPEC Qualification of Excipients Guide

IPEC Excipient Information Package Templates

IPEC Excipient Information Package User Guide

IPEC GMP Certification Scheme and CB Qualification Guide

IPEC-PQG Good Manufacturing Practices Guide

IPEC Excipient Composition Guide

IPEC Quality-by-Design Guide

IPEC Good Distribution Practices Guide

Technically Unavoidable Particle Profile (TUPP) Guide

PDA-IPEC Technical Report 54.6 – Table of Contents

IPEC Quality Agreement Guide and Template(s)

IPEC Significant Change Guide

QA – Manufacturer’s Quality Statement

QA Responsibility Table – Manufacturer’s Template

QA Responsibility Table – Distributor’s Template

Guides in other languages

Good Manufacturing Practices – French version

Good Distribution Practices – Spanish version

Significant Change – Spanish version

IPEC Excipient Information Package
Templates

IPEC Excipient Information Package
User Guide

IPEC Quality Agreement
Guide and Template(s)