International Pharmaceutical Excipients Council – IPEC Federation
Guidelines - IPEC Federation
IPEC Quality Agreement Guide and Templates(s) – ToC
Version 3 - 2024
General availability on 20 May.
Technically Unavoidable Particle Profile (TUPP) Guide – ToC
Version 2 - 2024
General availability on 5 May.
IPEC General Glossary of Terms and Acronyms
Version 3 - 2023
IPEC Significant Change Guide
Version 5 - 2023
IPEC Excipient Information Package User Guide – Sustainability
Version 1 - 2023
Part 4 – Sustainability Overview
IPEC Excipient Stability Guide
Version 2 - 2022
IPEC Certificate of Analysis (CoA) Guide
Version 2 - 2022
IPEC-PQG Good Manufacturing Practices Guide
Version 5 - 2022
IPEC Safety Guide
Version 1 - 2021
IPEC Good Distribution Practices (GDP) Audit Guide
Version 3 - 2021
IPEC Validation Guide
Version 1 - 2021
IPEC Excipient Information Package User Guide
Version 4 - 2020
IPEC Excipient Information Package Templates
Version 4 - 2020
IPEC Qualification of Excipients Guide
Version 2 - 2020
IPEC Good Distribution Practices Guide
Version 2 - 2017
IPEC Quality-by-Design Guide
Version 1 - 2020
PDA-IPEC Technical Report 54.6 Formalized Risk Assessment for Excipients
Version 1 - 2019
Purchase the document: https://techpubportal.pda.org/
IPEC Excipient Composition Guide
Version 2 - 2020
IPEC Quality Agreement Guide and Template(s)
Version 2 - 2017
An updated version is available to IPEC Members.
General availability: 20 May.
QA Responsibility Table – Distributor’s Template
Version 2 - 2017
An updated version is available to IPEC Members.
General availability: 20 May.
QA Responsibility Table – Manufacturer’s Template
Version 2 - 2017
An updated version is available to IPEC Members.
General availability: 20 May.
QA – Manufacturer’s Quality Statement
Version 2 - 2017
An updated version is available to IPEC Members.
General availability: 20 May.