Guidelines

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 Composition Guide

Version 2 – 2020
.

IPEC Excipient Information Package
Templates

Version 4 – 2020

IPEC Excipient Information Package
User Guide

Version 4 – 2020

Good Distribution Practices Guide

Version 2 – 2017

IPEC General Glossary of Terms and Acronyms

Version 1 – 2014

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

The 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

PDA-IPEC Technical Report 54.6 – Table of Contents

Version 1 – 2019
Purchase the Report