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My Fed

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

Guidelines

IPEC Validation Guide
Table of Contents

Version 1 – 2021

IPEC GMP Certification Scheme and CB Qualification Guide
Table of Contents

Version 1 – 2020

IPEC Quality-by-Design Guide
Table of Contents

Version 1 – 2020

IPEC Excipient Information Package
Templates

Version 4 – 2020

IPEC Excipient Information Package
User Guide

Version 4 – 2020

IPEC Qualification of Excipients Guide
Table of Contents

Version 2 – 2020

IPEC General Glossary of Terms and Acronyms

Version 1 – 2014

IPEC Excipient Composition Guide

Version 2 – 2020
.

IPEC Good Distribution Practices Guide

Version 2 – 2017

PDA-IPEC Technical Report 54.6 – Table of Contents

Version 1 – 2019
Purchase the Report

IPEC-PQG Good Manufacturing Practices Guide

Version 4 – 2017

Read the Statement

Technically Unavoidable Particle Profile (TUPP) Guide

Version 2 – 2015

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

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Guidelines

IPEC Validation Guide Table of Contents

IPEC GMP Certification Scheme and CB Qualification Guide Table of Contents

IPEC Quality-by-Design Guide Table of Contents

IPEC Excipient Information Package Templates

IPEC Excipient Information Package User Guide

IPEC Qualification of Excipients Guide Table of Contents

IPEC General Glossary of Terms and Acronyms

IPEC Excipient Composition Guide

IPEC Good Distribution Practices Guide

PDA-IPEC Technical Report 54.6 – Table of Contents

IPEC-PQG Good Manufacturing Practices Guide

Technically Unavoidable Particle Profile (TUPP) Guide

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

IPEC Validation Guide
Table of Contents

IPEC GMP Certification Scheme and CB Qualification Guide
Table of Contents

IPEC Quality-by-Design Guide
Table of Contents

IPEC Excipient Information Package
Templates

IPEC Excipient Information Package
User Guide

IPEC Qualification of Excipients Guide
Table of Contents

IPEC Quality Agreement
Guide and Template(s)