The International Pharmaceutical Excipients Council

Excipient
Information Package
User Guide and Template

Part IV: Sustainability Overview

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The International Pharmaceutical Excipients Council – Federation (IPEC Federation) asbl
2023
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W: ipec-federation.org T: +32 2 213 74 40 E: info@ipec-federation.org
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This document represents voluntary guidance for the excipient industry and the contents
should not be interpreted as regulatory requirements. Alternatives to the approaches in thisguide may be used to achieve an equivalent level of assurance for excipient quality.
This guide was created to help companies understand current expectations on this topic and is
not intended for use by third party certification bodies to conduct audits or to certify
compliance with the guide.
The content of this guide cannot be reproduced without the written authorization of the IPEC
Federation Management Body.

FOREWORD
The International Pharmaceutical Excipients Council (IPEC) is an international industry
association formed by excipient manufacturers, distributors, and end-users. At the current writing
there are regional pharmaceutical excipient industry associations located in the Americas,
Europe, Japan, China, and India. IPEC’s objective is to contribute to the international excipient
standards development and harmonization, provide information useful for new excipientdevelopment and introduction, and offer best practice and guidance concerning excipientdevelopment.
IPEC has three major stakeholder groups;
1. Excipient manufacturers and distributors, defined as suppliers in this document,
2. Medicinal (drug) product manufacturers, defined as excipient users in this document,
and3. Public health and regulatory authorities.

This section of the guide is intended to be voluntary, to indicate best practice, and to be globallyapplicable. However, it should be recognized that the laws and regulations applying to excipients

Copyright © 2023 The International Pharmaceutical Excipients Council
The International Pharmaceutical Excipients Council – Federation (IPEC Federation) asbl
Rue Marie de Bourgogne 52 - 1000, Brussels, Belgium
W: ipec-federation.org T: +32 2 213 74 40 E: info@ipec-federation.org
VAT: BE 0823931361 - IBAN: BE73363068125160 - RPM Brussels Capital Region

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will vary from region to region and country to country. In addition, the rules and regulations arecontinually evolving. It is the responsibility of the reader to review the most current version of any
applicable regulatory requirement. Versions referenced in the guide were based on versions
available at the time the guide was published.
In this guide, pharmaceutical excipient(s) will be referred as excipient(s). This guide may beapplied to veterinary medicines, as appropriate and include reference to specific veterinary
guidances and regulations.
Throughout the guide, justification implies that a decision is made based on a scientific, quality
and/or regulatory considerations.
This guide offers best practice and guidance in the establishment of an excipient sustainability
information package. It is not mandatory or binding and each company can make decisions on
their focus areas and specific topics to be included in this section.
Note: Refer to the “International Pharmaceutical Excipients Council Glossary: GeneralGlossary of Terms and Acronyms [1]” for definitions. The first use of a term found in theglossary will be in BOLD.

Copyright © 2023 The International Pharmaceutical Excipients Council
The International Pharmaceutical Excipients Council – Federation (IPEC Federation) asbl
Rue Marie de Bourgogne 52 - 1000, Brussels, Belgium
W: ipec-federation.org T: +32 2 213 74 40 E: info@ipec-federation.org
VAT: BE 0823931361 - IBAN: BE73363068125160 - RPM Brussels Capital Region

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Table of Contents
ACKNOWLEDGEMENTS ............................................................................................... 51

INTRODUCTION................................................................................................ 71.1Background ................................................................................................................ 71.2

Purpose and Scope ................................................................................................... 71.3

Principles Adopted .................................................................................................... 71.4

Format of the EIP Sustainability Section.................................................................. 82

ENVIRONMENT, SOCIAL AND GOVERNANCE INITIATIVES ........................ 8

2.1

Environmental Initiatives........................................................................................... 92.2

Social Considerations ..............................................................................................102.3

Governance ...............................................................................................................113

PRODUCT SUSTAINABILITY ATTRIBUTES ................................................. 124SOURCING AND SUPPLY INITIATIVES ........................................................ 134.1

Corporate Responsible Sourcing/Sustainable Procurement Policy .....................134.2

Suppliers/Subcontractors Engagement ..................................................................134.3

Sourcing of Material .................................................................................................145

HEALTH AND SAFETY ................................................................................... 145.1

Legal Awareness and Industry Standards ..............................................................145.2

Product Safety (Hazard Information) .......................................................................155.3

Transportation Safety ...............................................................................................155.4

Process Safety ..........................................................................................................155.5

Occupation Health and Safety (Worker Protection) ...............................................165.6

Emergency Preparedness ........................................................................................166

BUSINESS CONTINUITY PLAN (BCP) .......................................................... 177REFERENCES................................................................................................. 18

Copyright © 2023 The International Pharmaceutical Excipients Council
The International Pharmaceutical Excipients Council – Federation (IPEC Federation) asbl
Rue Marie de Bourgogne 52 - 1000, Brussels, Belgium
W: ipec-federation.org T: +32 2 213 74 40 E: info@ipec-federation.org
VAT: BE 0823931361 - IBAN: BE73363068125160 - RPM Brussels Capital Region

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ACKNOWLEDGEMENTS
This guide was developed by representatives of the associations which constitute the IPEC
Federation (IPEC). The IPEC Federation greatly appreciates the many hours devoted by the coreteam of individuals and other contributors listed below, to make this guide available to IPEC
members and the broader excipient community. Equally, IPEC extends its thanks to theemployers of those same contributors who provided the necessary time and resources, without
which, this guide would not be possible.
The company representatives who worked on this guide are listed below:

List of Contributors from IPEC-Americas
Meera Raghuram, Lubrizol – Chair
Jill Bronkema, PerrigoDavid Schoneker, Black Diamond Regulatory Consultant
Katherine Ulman, KLU Consulting
Priscilla Zawislak, IFF

List of Contributors from IPEC Europe
Geertrui Haest, Cargill
Viola Hieble-Gerhard, Evonik
Iain Moore, Croda

List of Contributors from IPEC Japan
Hiroshi Watanabe, Shin-Etsu
Fumiaki Ohbayashi, IPEC Japan
Keiko Tsutsumi, Colorcon
Kae Yamamoto, DFE Pharma
Masayo Kuroda, BASF
Hiroyasu Nakanishi, Asahi Kasei
Takayuki Shigematsu, NISSO
Shingo Kikuchi, Shin-Etsu

Copyright © 2023 The International Pharmaceutical Excipients Council
The International Pharmaceutical Excipients Council – Federation (IPEC Federation) asbl
Rue Marie de Bourgogne 52 - 1000, Brussels, Belgium
W: ipec-federation.org T: +32 2 213 74 40 E: info@ipec-federation.org
VAT: BE 0823931361 - IBAN: BE73363068125160 - RPM Brussels Capital Region

5 of 18List of Contributors from IPEC China
Cissy Wang, Ashland
Shine Gao, DKSH China
Elly Song, Dow
Martin Tao, IFF

List of Contributors from IPEC India
Vishakha Metkar, Colorcon
M.K. Naseerulla, SPI Pharma
Aditi Telang, IFF

Copyright © 2023 The International Pharmaceutical Excipients Council
The International Pharmaceutical Excipients Council – Federation (IPEC Federation) asbl
Rue Marie de Bourgogne 52 - 1000, Brussels, Belgium
W: ipec-federation.org T: +32 2 213 74 40 E: info@ipec-federation.org
VAT: BE 0823931361 - IBAN: BE73363068125160 - RPM Brussels Capital Region

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