
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
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IPEC Good Distribution Practices Guide
Version 2 – 2017

PDA-IPEC Technical Report 54.6 – Table of Contents
Version 1 – 2019
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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