IPEC Federation Guides and Papers of 2021

The collaborative efforts of the five IPECs helped publishing four IPEC Federation guides and one position paper in 2021. Here is a short summary of all guides and papers published by the IPEC Federation.

Position Papers

Pharmaceutical Lactose used in oral preparations is a low-risk excipient 

Regulatory authorities worldwide increasingly seek to classify pharmaceutical excipients according to the risk they may present to patients when used in dosage forms.
Although lactose is derived from an animal derived material (whey), this position paper seeks to support pharmaceutical grade lactose as a low-risk excipient in oral dosage forms. IPEC Federation considers that pharmaceutical grade lactose has a low risk profile with respect to chemical and biological risks when used in oral pharmaceutical preparations. Read here the full press release.

Read the Position Paper


IPEC Validation Guide 

The guide was developed to help describe activities taken by excipient manufacturers to test and evaluate their systems, processes and methods in order to provide a high degree of assurance that they consistently produce results meeting predetermined acceptance criteria. It recognizes that an excipient manufacturer often does not perform “validation” activities in the same manner or to the same extent as the pharmaceutical industry, however, many activities that they do perform leads to the same degree of assurance. Read here the full press release.

Download the IPEC Validation Guide

IPEC Glossary of Terms and Acronyms

First published in 2014, the updated Glossary of Terms and Acronyms introduces a new set of criteria for terms/definitions to be included in future versions of the glossary. Read more about these criteria here. Another new feature to this Glossary is a column that includes reference to a list of external sources where the term has been defined.  Several of the sources include ICH Guidelines and WHO Technical Reports where the definitions are often more applicable to API than excipient; therefore, the defined definition in this Glossary may have been modified to be more appropriate for an excipient. Read here the full press release.

Download the IPEC Glossary of Terms and Acronyms

IPEC Good Distribution Practices Audit Guide

The IPEC GDP Audit Guide provides a comprehensive tool for companies auditing the supply chain of pharmaceutical excipients. Several incidents in the past were caused by a lack of supply chain security and inappropriate handling of pharmaceutical excipients. This has moved regulators, users, manufacturers and distributors to take action.
The GDP Audit Guide should be used in conjunction with the IPEC Good Distribution Practices Guide. It serves as a valuable tool to help the auditor conduct a complete audit of all relevant GDP principles for pharmaceutical excipients. Read the full press release.

Download the IPEC GDP Audit Guide

IPEC Safety Guide

The IPEC Safety Guide has been designed to give an overview on recommended toxicological studies for different therapeutic applications, routes of administration and treatment periods. Toxicological safety studies described in this guide are intended for consideration by excipient manufacturers who market excipients for use in drug formulations and excipient users who conduct toxicology studies required for the initial approval of a novel excipient in a drug formulation. Read here the full press release.

Download the Table of Contents of the IPEC Safety Guide