2009 - IPEC Excipient Information Package

IPEC
EXCIPIENT INFORMATION
PACKAGE (EIP):
TEMPLATE AND USER GUIDE
2009
Copyright © 2009 The International Pharmaceutical Excipients Council

This document represents voluntary guidance for the pharmaceutical excipient industry and the
contents should not be interpreted as regulatory requirements. Alternative approaches to those
described in this guide may be implemented.
FOREWORD
IPEC is an international industry association formed in 1991 by manufacturers and end-users

of excipients. It is an association comprising four regional pharmaceutical excipient industry
associations covering North America, Europe, China and Japan (which are known
respectively as IPEC-Americas, IPEC Europe, IPEC-China and JPEC). IPEC’s objective is to
contribute to the development and harmonization of international excipient standards, the
introduction of useful new excipients to the marketplace and the development of best practice
and guidance concerning excipients.
IPEC has three major stakeholder groups;

1. Excipient manufacturers and distributors, who are called suppliers
2. Pharmaceutical manufacturers, who are called users
3. Regulatory authorities who regulate medicines
Suppliers IPEC Users
Regulatory
Authorities
This document offers best practice and guidance in the establishment of an excipient
information package. The excipient supplier may be a manufacturer or a distributor (or both).
The Guide highlights the factors to consider when preparing such a package.
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ACKNOWLEDGEMENTS
This guideline is the result of the hard work and substantial resources, of IPEC member
companies. IPEC greatly appreciates the many hours the following individuals devoted to
develop this guide and the generous support of their employers for providing the necessary
time and resources.
IPEC-AMERICAS
• Alexa Smith, Colorcon
• Priscilla Zawislak, Hercules Incorporated
• Craig Scott, JRS Pharma LP
• Laura Horne, Mutchler, Inc.
• David B. Klug, sanofi-aventis
• Maria Guazzaroni Jacobs, Pfizer
• Londa Ritchey, Wyeth
• Chris Armstrong, Evonik
• Judy Emmert, Abbott
• Ann Van Meter, Dow
• Cindy Libonati, Purdue Pharma L.P.
IPEC EUROPE
• Iain Moore, Croda
• Kevin McGlue, Colorcon Limited
• Carl Mroz, Colorcon Limited
• Rebecca Roberts, Colorcon Limited
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INTRODUCTION
SCOPE AND PURPOSE
In order to use an excipient, users need to obtain a significant amount of data about the
excipient manufacturer, distributor, where applicable, and the excipient itself. Many users
have resorted to sending questionnaires and surveys to obtain this information using their
own individual formats. Often these surveys and questionnaires address essentially the same
quality and regulatory concerns. It is also difficult in some cases, due to the phrasing of
specific questions, to interpret the intent of the question.
While excipient suppliers want to provide information to the user as quickly as possible,
many excipient suppliers receive such a large volume of questionnaires and surveys from
their customers that they are unable, due to resource constraints, to individually complete
each customer’s specific form. Further, because these surveys and questionnaires vary to
some degree in the specific questions asked, if a change in the information occurs, it is
virtually impossible for the excipient supplier to determine which completed surveys and
questionnaires are affected by the change. Significant time and resources are spent, both by
the user and supplier, to send, complete, return, review and track these non-standardized
questionnaires and surveys.
This guide was developed in order to address these issues. It defines the Standardized
Excipient Information Package that comprises:
• Product Regulatory Datasheet

• Site Quality Overview
• Site And Supply Chain Security Overview
The primary goal of the template is to provide standards for the exchange of data between
excipient suppliers and users that will simplify this process. By responding to surveys,
questionnaires and other requests for information in this format, excipient suppliers can
respond in a timely and efficient manner to all requests as well as ensure that consistent
information is provided. Excipient users will be able to anticipate the type and format of the
standard data that they receive from excipient suppliers. This will assist both users and
suppliers in the task of information management. In the future, electronic transmission of this
data for direct download may be possible. Additionally, this standardization will facilitate any
necessary change notifications pertaining to previously supplied information further
strengthening the excipient suppliers’ change notification program.
FORMAT OF THE EXCIPIENT INFORMATION PACKAGE DOCUMENTS
The Excipient Information Package (EIP) is set up much like a Material Safety Data Sheet
(MSDS) with designated sections to include specified data. Each section covers specific
topics. The minimum topics that should be covered in each section are defined, however,
additional related information can also be provided at the discretion of the excipient supplier.
If particular topics are not applicable to a particular excipient or site, it should be so indicated
in the document. Where information is considered confidential, the document should reflect
how the excipient user can obtain this information. For example, the document may state that
the information may only be obtained under a confidentiality agreement.
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The presentation and format of the information is at the discretion of the supplier Short,
bulleted formats are encouraged. Specific phrasing is not prescribed but suggested phrasing is
provided in some sections and can be used if desired. Job titles should be used rather than
names.
These documents should be version controlled by the excipient supplier. Suppliers should
have a process in association with their management of change policy for updating EIP
documents in a timely manner including updates to company and product information and
EIP template revisions. The current version of the EIP template can be found on the IPEC
website.
The documents do not require signatures, however they must be an official company
document.
APPLICATION AND USAGE
The EIP documents are intended for individuals experienced and competent in the area of
evaluating excipient suppliers and should not be viewed as a replacement for audits. While
the documents are intended to form a complete package of information, each document
within the EIP was designed to also be functional as a stand-alone document and therefore,
some basic information may be common among the documents.
In order to provide additional guidance on specific topics, IPEC maintains a Regulatory

Reference Guidance. The Regulatory Reference lists links to the specific regulatory
references applicable in different regions to various sections in the EIP documents. These
references can provide preparers of EIP documents detailed guidance on the information that
needs to be addressed in various sections. IPEC’s Regulatory Reference Guidance is
accessible through the IPEC-Americas website at the following address:
www.ipecamericas.org.
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SECTION BY SECTION EVALUATION OF THE EXCIPIENT INFORMATION
DOCUMENTS
I. Product Regulatory Datasheet
The Product Regulatory Datasheet is designed as a means to assist in communicating to

the user important physical, manufacturing and regulatory information specific to the
excipient. This information is intended to facilitate the use of the excipient in drug
products. Not every point is necessarily applicable to each excipient.
The following sections are expected to be included in the document unless otherwise
specified.
Section 1 – General Product Information

This section provides identification information for the product .
Topics for this section:
• Product name/code
• Scope of document
• Other general product information (optional)
Section 2 – Manufacturing, Packaging, Release Site and Supplier Information

This section provides general information about where the product is manufactured
and other supply chain information. Include cross references to the Site Quality
Overview and Site and Supply Chain Security Overview, where applicable.
• Sites of manufacturing, processing, packaging, product release
and other related sites such as warehousing, terminals, contract
labs, etc.
• Exclusive distribution channels (if applicable)
• GMP or GDP compliance statement, as applicable
• Multi purpose / dedicated equipment
Section 3 – Physico-chemical Information

This section provides general information about the chemistry and physical
characteristics of the product and its manufacture.
• CAS number
• Origin information (synthetic, animal, vegetable, mineral,
product of biotechnology, product of fermentation, etc.)
• Synonyms (including INCI name if applicable) (Optional)
• Morphological form (Optional)
• Brief description of manufacture (blend, reaction, continuous /
batch process etc.)
• Mixed excipient ingredient statement
• Country of origin for ingredients used in mixed excipients
(optional)
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Section 4 - Regulatory Information
This section includes information related to the regulatory status of the excipient as
well as addressing pertinent product specific topics of general regulatory concern.
• Compendial compliance (for example, USP-NF, FCC, PhEur or
BP, JP, JPE, JSFA) and other regulatory status (For example,
21 CFR, GRAS, other status as a food additive, European
cosmetic directive compliance)
• Drug Master File (DMF) or EDQM Certificate of Suitability or
other Master File availability
• BSE / TSE Information (both related to the product and the
potential for cross-contamination). EDQM Certificate of
Suitability information, if applicable
• Viral safety, if applicable
• Allergens / Hypersensitivities Information (both related to the
product and the potential for cross-contamination) – Reference
the Regulation or specific allergens evaluated.
• GMO Information
• Residual Solvents Information
• Metal catalyst and metal reagent residues
• Kosher / Halal status
• Irradiation treatment, if applicable
• Bioburden/pyrogens (Optional)
• Other concerns, as applicable, such as Proposition 65,
aflatoxins or other toxins, preservatives, latex, silicones, status
with respect to use in foods labelled as organic or as containing
organic ingredients, etc. (Optional)
Section 5 - Miscellaneous Product Information

This section should be used by the supplier to provide any additional information that
may be pertinent to the product but is not covered elsewhere in this document or in
the other EIP documents.
• Explanation of the lot/batch numbering system
• Description of batch definition
• Expiration date and/or recommended re-evaluation interval
• Specific storage and shipping conditions which are required to
assure excipient quality
• Common uses (Optional)
• Nutritional information (Optional)
• Packaging e.g. specification, size, types, new/recycled, bulk
tankers, type of tamper evidence devices and labelling
information (Optional)
Section 6 – Revisions
This section provides information related to version control for the document. The
document should have a date and a version number. This section should also describe
the changes made since the last revision.
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Section 7 - Contact Information
This section explains how the user should contact the supplier to get additional
information, if needed, regarding the topics provided in this document.
II. Site Quality Overview
The Site Quality Overview is a tool to assist in evaluating the manufacturing practices
and quality systems of suppliers, as well as a reference to inform users of the systems in
place to assure appropriate GMP requirements. The “Joint IPEC-PQG Good
Manufacturing Practice Guide for Pharmaceutical Excipients 2006" was used as the
basis to construct this document and should serve as the primary source for evaluating
responses provided by the supplier. Users of this document should be familiar with the
introduction, definitions, and general guidance that are contained within the IPEC-PQG
GMP Guide, and should refer to the guide if further details are needed.
The Site Quality Overview is intended to communicate a summary of the Quality

Systems and GMP used to manufacture the excipient(s). It may not necessarily include
all of the details covered in an audit, nor are all of the points necessarily appropriate to
every site.
specified.
Section 1 - Site Overview

The purpose of this section is to describe the supplier’s organization and production
capabilities.
• Scope
− Site Name(s)
− Address(es)
− Excipients covered by this document (optional)
• Corporate ownership (if different from site identified in Scope)
• Customer audit policy (optional)
• Site Details
− General Site Information (e.g. size, history, number of
employees, shift operations, site plan, union workforce
(optional), etc)
− Site activities conducted (e.g. blending, packaging, testing,
R&D)
− Primary applications of products produced at this site
(pharmaceutical, food, cosmetic, etc)
− Facility production of antibiotics, steroids, or hormone
products
− Organizational chart (including responsibility for product
release)
− Use scope and control of sub-contractors, if applicable
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Section 2 - Compliance Evidence
This section should be used to describe any specific compliance information pertinent
to the facility being described.
Suggested examples of compliance information:
• ISO registration information e.g. 9001, 14001, OHSAS 18001, etc.
(number, registrar, copies of certificates)
• GMP Inspections by Competent Authorities (Regulatory Agencies)
including outcome
• General GMP statements
• Other certifications or external audit programs: IPEA, AIB, GMA-SAFE,
BRC, etc.
Section 3 – IPEC-PQG GMP Compliance Details:

This section should be used to address how the supplier complies with each applicable
element of the IPEC-PQG GMP Guide. Non-applicable elements should be noted as
such. For more detail on the specific items that may be covered under each topic,
please refer to the IPEC-PQG GMP Guide. Parenthetical references in the document
template refer to sections in the IPEC-PQG GMP Guide. Additional reference
information can be found in the IPEC-PQG GMP Audit Guideline for Pharmaceutical
Excipients.
Section 4 - Miscellaneous Site Information

This section should be used by the supplier to provide any additional information that
may be pertinent to the site but is not covered elsewhere in this document or in the
other EIP documents. This section is optional and should be used as needed.
Suggested topics for this section:
• Risk management plans such as HACCP
• Statistical Process Control / Process Analytical Technology (PAT)
This section provides information related to version control for the document. The
document should have a date and a version number. This section should also describe
the changes made since the last revision.

information, if needed, regarding the topics provided in this document.
III. Site And Supply Chain Security Overview
The Site And Supply Chain Security Overview is designed to provide users with
information concerning the supplier's plans to ensure the protection of the product and
the continuity of supply. It is intended to provide a high level overview of these plans
while preserving confidential information.
specified.
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Section 1 - Scope
The purpose of this section is to identify the manufacturing site and distribution
site(s) (where applicable) covered by this document.
• Scope
• Site Name(s)
• Address(es)
• Excipients covered by this document (optional)
• Corporate ownership (if different from site identified in Scope)
Section 2 - Supply Chain Security

The purpose of this section is to describe how the supplier assures the integrity of
the excipient during storage and distribution and also complies with appropriate
regulations to the user. Also covered should be any arrangements to comply with
appropriate regulations concerning the transportation of the excipient. More
details on these issues can be found in the IPEC Good Distribution Practices
Guide 2006.
• Controls to assure the integrity and security of the product in transit
from manufacturer to end user. The following are suggested areas
that may be discussed where applicable:
− Evaluation of carriers
− Tamper evident packaging
− Environmental control (if appropriate)
− Qualification of distributors
− Qualification of forwarders/brokers
− Qualification of intermediate storage locations
− Repacking/relabelling activities
• Registrations with the FDA under the BioTerrorism Act, if
applicable
• C-TPAT or AEO Participation, if applicable
• Approved distributors and how material pedigree/traceability is
assured (where applicable) (Optional)
Section 3 - Security Information

The purpose of this section is to describe the elements of the supplier’s overall
security program.
• Scope of security plan including:
− Roles and Responsibilities, including title of person responsible
for implementing security
− Policies & Procedures
− Training
− Data and computer system protection
− Site access control (e.g. security fencing, visitor registration,
employee badges, employee training, vehicular access, camera
monitoring)
• Personnel security
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− Pre-employment background checks
− Background checks on temporary and contract personnel
− Training
− Termination of employees or contractors and preventing
subsequent access to the site and computer systems
Section 4 - Safety & Environmental Information

The purpose of this section is to describe the supplier’s personnel safety and
environmental programs.
• Description of documented health and safety program
• Registrations to ISO 14001, OHSAS 18001 and/or Responsible
Care etc.
• Description of documented emergency response plan
Section 5 - Miscellaneous Site Information

This section should be used by the supplier to provide any additional information
that may be pertinent to the site but is not covered elsewhere in this document or
in the other EIP documents. This section is optional and should be used as needed.
Suggested topics for this section:
• Corporate social responsibility programs
• Business continuity plans
This section provides information related to version control for the document.
The document should have a date and a version number. This section should
also describe the changes made since the last revision.

information, if needed, regarding the topics provided in this document
.
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EIP DOCUMENT TEMPLATES
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COMPANY LOGO/LETTERHEAD/OFFICIAL STATIONERY/COMPANY DOCUMENT
PRODUCT REGULATORY DATASHEET
Section 1 – General Product Information
Product name/code
Scope of document
Other general product information (optional)
Section 2 – Manufacturing, Packaging, Release Site and Supplier Information
Sites of manufacturing, processing, packaging, product release and other related sites such as
warehousing, terminals, contract labs, etc.
Exclusive distribution channels (if applicable)
GMP or GDP compliance statement, as applicable
Multi purpose/dedicated equipment
Section 3 – Physico-chemical Information
CAS number
Origin information (synthetic, animal, vegetable, mineral, product of biotechnology, product
of fermentation, etc.)
Synonyms (including INCI name if applicable) (Optional)
Morphological form (Optional)
Brief description of manufacture (blend, reaction, continuous / batch process etc.)
Mixed excipient ingredient statement
Country of origin for ingredients used in mixed excipients (optional)
Section 4 - Regulatory Information
Compendial compliance and other regulatory status

Drug Master File (DMF) or EDQM Certificate of Suitability or other Master File availability
BSE/TSE Information (both related to the product and the potential for cross-contamination)
EDQM Certificate of Suitability information, if applicable
Viral safety, if applicable
Allergens/Hypersensitivities Information (both related to the product and the potential for
cross-contamination) – Reference the Regulation or specific allergens evaluated
GMO Information
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Residual Solvents Information
Metal catalyst and metal reagent residues
Kosher/Halal status
Irradiation treatment, if applicable
Bioburden/pyrogens (Optional)
Other concerns, as applicable (Optional)
Explanation of the lot/batch numbering system

Description of batch definition batch sizes
Expiration date and/or recommended re-evaluation interval
Storage and shipping conditions (where necessary to assure excipient quality)
Common uses (Optional)
Nutritional information (Optional)
Packaging e.g. specification, size, types, new/recycled, bulk tankers, type of tamper evidence
devices and labelling information (Optional)
See User’s Guide for other optional information to include in this section
Section 6 Revision history

See User’s Guide for suggested information to include in this section
Section 7 Contact Information

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SITE QUALITY OVERVIEW
Section 1 Facility Overview
Scope
− Site Name(s)
− Address(es)
− Excipients covered by this document (optional)
Corporate ownership (if different from site identified in Scope)
Customer audit policy (optional)
Site Details
− General Site Information (e.g. size, history, number of employees, shift
operations, site plan, union workforce (optional), etc)
− Site activities conducted (e.g. blending, packaging, testing, R&D)
− Primary applications of products produced at this site (pharmaceutical, food,
cosmetic, etc)
− Facility production of antibiotics, steroids, or hormone products
− Organizational chart (including responsibility for product release)
− Use scope and control of sub-contractors, if applicable
Section 2 - Compliance Evidence
Include as applicable:
ISO registration number and registrar certificates
GMP Inspections by Competent Authorities (Regulatory Agencies) including outcome
General GMP statements
Other certifications or external audit programs
Section 3 – IPEC-PQG GMP Compliance Details:
Site compliance with the IPEC-PQG GMP Guide 2006 (if another level of GMP are
used please specify). Parenthetical references are from the IPEC-PQG Good
Manufacturing Practices Guide for Pharmaceutical Excipients 2006.
Quality Management Systems-Excipient Quality Systems (4)

− General Requirements (4.1)
− Documentation Requirements (4.2)
− Change Control (4.3)
Management Responsibility (5)

− Management Commitment (5.1)
− Customer Focus (5.2)
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− Quality Policy (5.3)
− Planning (5.4)
− Responsibility, Authority and Communication (5.5)
− Management Review (5.6)
Resource Management (6)

− Provision of Resources (6.1)
− Human Resources (6.2)
− Infrastructure (Facilities and Equipment) (6.3)
− Work Environment (6.4)
Product Realization (7)

− Planning of Product Realization (7.1)
− Customer-Related Processes (7.2)
− Design and Development (7.3)
− Purchasing (7.4)
− Production and Service Provision (7.5)
− Control of Measuring and Monitoring Devices (7.6)
Measurement, Analysis and Improvement (8)

− General (8.1)
− Monitoring and Measurements(8.2)
− Control of Nonconforming Product (8.3)
− Analysis of Data (8.4)
− Improvement (8.5)
Section 4 Miscellaneous Site Information (Optional)



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SITE AND SUPPLY CHAIN SECURITY OVERVIEW
Section 1 - Scope
Site Name(s)
Address(es)
Excipients covered by this document (optional)
Corporate ownership (if different from site identified in Scope)
Section 2 - Supply Chain Security
Controls to assure the integrity and security of the product in transit from manufacturer to end
user. The following are suggested areas that may be discussed where applicable:
− Evaluation of carriers
− Tamper evident packaging
− Environmental control (if appropriate)
− Qualification of distributors
− Qualification of forwarders/brokers
− Qualification of intermediate storage locations
− Repacking/relabelling activities
Tamper evidence
Registrations with the FDA under the BioTerrorism Act, if applicable
C-TPAT or AEO Participation, if applicable
Approved distributors and how material pedigree is assured (where applicable) (Optional)
Section 3 - Security Information
Scope of security plan including:

− Roles and Responsibilities, including title of person responsible for implementing
security
− Policies & Procedures
− Training
− Data and computer system protection
− Site access control (e.g. security fencing, visitor registration, employee badges,
employee training, vehicular access, camera monitoring)
Personnel security
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− Pre-employment background checks
− Background checks on temporary and contract personnel
− Training
− Termination of employees or contractors and preventing subsequent access to the site
and computer systems
Section 4 - Safety & Environmental Information
Description of documented health and safety program

Registrations to ISO 14001, OHSAS 18001 and/or Responsible Care etc.
Description of documented emergency response plan



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DEFINITIONS AND GLOSSARY
21 CFR Title 21 of the United States Code of Federal Regulations

Product Regulatory Datasheet – Section 4
AEO Authorised Economic Operator – status applied to organisations in
Europe which permits them to regulatory relief from customs
inspections and documentary requirements. Akin to C-TPAT in
that it also requires supply chain security measures to be
implemented.
Site and Supply Chain Security Overview – Section 2
Aflatoxins The aflatoxins are a group of structurally related toxic compounds
produced by certain strains of the fungi Aspergillus flavus and A.
parasiticus. Under favorable conditions of temperature and
humidity, these fungi grow on certain foods and feeds, resulting in
the production of aflatoxins. The most pronounced contamination
has been encountered in tree nuts, peanuts, and other oilseeds,
including corn and cottonseed. Aflatoxicosis is poisoning that
results from ingestion of aflatoxins in contaminated food or feed.
AIB The American Institute of Baking
Site Quality Overview – Section 2
Allergens A substance that causes an abnormal response by the immune
system to certain proteins found in the substance.
Animal Sourced Contains starting materials of animal origin.
Active Pharmaceutical Any substance, or mixture of substances, intended to be used in the
Ingredient (API) manufacture of a drug product and that, when used in the
production of a drug, becomes an active ingredient of the drug
product. Such substances are intended to furnish pharmacological
activity or other direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease or to affect the structure or any
function of the body of man or animals.
Batch/Lot A specific quantity of material produced in a process or series of
processes so that it can be expected to be homogeneous. In the case
of continuous processes, a batch may correspond to a defined
fraction of the production. The batch size can be defined either by a
fixed quantity or by the amount produced in a fixed time interval.
Bioterrorism Act The United States Public Health Security and Bioterrorism
Preparedness and Response Act of 2002
BP British Pharmacopoeia
BRC British Retail Consortium
BSE Bovine Spongiform Encephalopathy, a slowly progressive,
degenerative, fatal disease affecting the central nervous system of
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adult cattle. The exact cause of BSE is not known but it is generally
accepted by the scientific community that the likely cause is
infectious forms of a type of protein, prions, normally found in
animals cause BSE. In cattle with BSE, these abnormal prions
initially occur in the small intestines and tonsils, and are found in
central nervous tissues, such as the brain and spinal cord, and other
tissues of infected animals experiencing later stages of the disease.
There is a disease similar to BSE called Creutzfeldt-Jacob Disease
(CJD) that is found in people. A variant form of CJD (vCJD) is
believed to be caused by eating contaminated beef products from
BSE-affected cattle.
CAS Number Chemical Abstracts Service Registry Number. The CAS Registry is
the largest substance identification system in existence. When a
chemical substance, newly encountered in the literature, is
processed by CAS, its molecular structure diagram, systematic
chemical name, molecular formula, and other identifying
information are added to the Registry and it is assigned a unique
CAS Registry Number.
Certificate of Certification granted to individual manufacturers by the European
Suitability to the Pharmacopoeia when an excipient or active ingredient is judged to
European be in conformity to a monograph or General Chapter 5.2.8 on
Pharmacopoeia (CEP) "Minimising the risk of transmitting animal spongiform
encephalopathy agents via medicinal products"
Country of Origin Country of manufacture, meaning the last country in which a
substantial transformation of the product occurred. A substantial
transformation occurs if a new article with a different name,
character, and use is created.
C-TPAT Customs-Trade Partnership Against Terrorism is a joint government
(US Customs)-business initiative to build cooperative relationships
that strengthen overall supply chain and border security.
Drug Master File A Drug Master File (DMF) is a submission to the Food and Drug
(DMF) Administration (FDA) that may be used to provide confidential
detailed information about facilities, processes, or articles used in
the manufacturing, processing, packaging, and storing of one or
more human drugs.
EDQM European Directorate for the Quality of Medicines
Excipient Substances other than the API which have been appropriately
evaluated for safety and are intentionally included in a drug
delivery system.
Expected Elements of the EIP documents that should be included and
addressed in the EIP documents.
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Expiration Date The date beyond which a product may no longer conform to
relevant specifications.
FCC Food Chemicals Codex
GDP Good Distribution Practice deals with the distribution of products,
including requirements for purchase, receiving, storage and export.
GDP regulates the movement of products from the premises of the
manufacturer to the end user, or to an intermediate point by means
of various transport methods.
GMA - SAFE The GMA (Grocery Manufacturers Association) - SAFE
assessment is a thorough description of a food production, handling
or storage facility’s policies and practices, documented by a skilled
auditing practitioner and communicated through a web based data
management & reporting system that allows individual users of the
assessment to determine if the audited facility will meet their own
standards.
GMO Genetically Modified Organism, meaning an organism, with the
exception of human beings, in which the genetic material has been
altered in a way that does not occur naturally by mating and/or
natural recombination.
GMP Good Manufacturing Practice. Requirements for the quality system
under which drug products and their ingredients are manufactured.
Current Good Manufacturing Practice (cGMP) is the applicable
term in the United States. For the purposes of this guide, the terms
GMP and cGMP are equivalent.
GRAS "GRAS" is an acronym for the phrase Generally Recognized As
Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and
Cosmetic Act (the Act), any substance that is intentionally added to
food is a food additive, that is subject to premarket review and
approval by FDA, unless the substance is generally recognized,
among qualified experts, as having been adequately shown to be
safe under the conditions of its intended use, or unless the use of the
substance is otherwise excluded from the definition of a food
additive.
HACCP Hazard Analysis Critical Control Point
Halal The term indicates that an item is permitted and fit for consumption
by Muslims.
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Hypersensitivity A violent reaction by the immune system to a substance that is
normally considered harmless.
INCI Name International Nomenclature of Cosmetic Ingredients as defined in
the Cosmetic, Toiletry and Fragrance Association’s (CTFA)
publication, the Cosmetic Ingredient Dictionary and Handbook.
IPEA International Pharmaceutical Excipients Auditing, Inc.
ISO International Organization for Standardization
ISO 14001 The International Organization for Standardization’s family of
standards on environmental management
OHSAS 18001 International occupational health and safety management system
specification.
JP Japanese Pharmacopoeia
JPE Japanese Pharmaceutical Excipients
JSFA Japanese Standards for Food Additives
Kosher The term indicates that an item is fit for consumption according to
Jewish law.
Mineral Based Contains starting materials of mineral origin.
MSDS Material Safety Data Sheet
Mixed Excipient A mixed excipient is defined as a simple physical mixture of two or
more compendial or non-compendial excipients produced by means
of a low- to medium-shear process where the individual
components are mixed but remain as discrete chemical entities, i.e.
the nature of the components is not chemically changed.
Nutritional The declaration of specific nutritional components such as total
Information calories, calories from fat , total fat, saturated fat, cholesterol,
sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A,
vitamin C, calcium, iron.
Optional Suggested topics that should be considered for inclusion in an EIP
document.
Organic (organically Specific practices addressing livestock breeding, cultivation of
grown) crops, the level of processing and the production of food.
Pedigree Documentation that provides traceability of the material throughout
the supply chain.
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PhEur European Pharmacopoeia
Process Analytical A system for designing, analyzing, and controlling manufacturing
Technology (PAT) through timely measurements (i.e., during processing) of critical
quality and performance attributes of raw and in-process materials
and processes with the goal of ensuring final product quality.
Product of A product derived from any technological application that uses
Biotechnology biological systems, living organisms, or derivatives thereof, to
make or modify products or processes for specific use.

Product of A product derived from a process in which living cells harvest fuel
Fermentation molecules from a substance in order to generate ATP for their own
energy needs. During that process, metabolic and bio-chemical
alteration of the physico-chemical makeup of the fermented product
occurs.
Proposition 65 The California Safe Drinking Water and Toxic Enforcement Act of
1986, better known by its original name of Proposition 65, is “right
to know” legislation regarding substances known to the State of
California to cause cancer or birth defects or other reproductive
harm.
Recommended Re- The period beyond which the bulk pharmaceutical excipient should
evaluation Interval not be used without further appropriate re-examination.
Residual Solvents Residual Solvents, USP/NF General Chapter <467>
Residual solvents are defined as organic chemicals that are used or

produced in the manufacture of active substances or Excipients, or
in the preparation of medicinal products. ICH Q3C Impurities:
Residual Solvents
Responsible Care A voluntary program to achieve improvements in environmental,
health and safety performance.
Adopted by most Chemical Industry associations worldwide.
Site A location where the excipient is manufactured. This may be within
the facility but in a different operational area or at a remote facility
including a contract manufacturer.
Statistical Process Statistical process control involves using statistical techniques to
Control measure and analyze the variation in processes.
Supplier A manufacturer or distributor who directly provides an excipient to
the user.
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Synthetic Products which are not derived from starting materials sourced
from plants, animals or minerals and that are not products of
fermentation. Note: Also see specific regional or national organic
food legislation for additional information on the use of the term
synthetic.
TSE Transmissible Spongiform Encephalopathies. TSE's are rare forms
of progressive neurodegenerative disorders that affect both humans
and animals and are caused by similar uncharacterized agents that
generally produce spongiform changes in the brain. Specific
examples of TSE's include: scrapie, which affects sheep and goats;
BSE, which affects cattle; transmissible mink encephalopathy;
feline spongiform encephalopathy; chronic wasting disease (CWD)
of mule deer, white-tailed deer, black-tailed deer, and elk; and in
humans, kuru, Creutzfeldt-Jakob disease, Gerstmann-Straussler
syndrome, fatal familial insomnia, and variant Creutzfeldt-Jakob
disease (vCJD).
USP-NF United States Pharmacopeia/National Formulary
Vegetable Sourced Contains starting materials of plant origin.
Version 1 May 2009

Page 24 of 24

2009 - IPEC Excipient Information Package

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IPEC

Copyright © 2009 The International Pharmaceutical Excipients Council

IPEC is an international industry association formed in 1991 by manufacturers and end-users

IPEC has three major stakeholder groups;

Suppliers IPEC Users

Version 1 May 2009

Version 1 May 2009

SCOPE AND PURPOSE

• Product Regulatory Datasheet

FORMAT OF THE EXCIPIENT INFORMATION PACKAGE DOCUMENTS

Version 1 May 2009

APPLICATION AND USAGE

In order to provide additional guidance on specific topics, IPEC maintains a Regulatory

Version 1 May 2009

I. Product Regulatory Datasheet

The Product Regulatory Datasheet is designed as a means to assist in communicating to

Section 1 – General Product Information

Section 2 – Manufacturing, Packaging, Release Site and Supplier Information

Section 3 – Physico-chemical Information

Version 1 May 2009

Section 5 - Miscellaneous Product Information

II. Site Quality Overview

The Site Quality Overview is intended to communicate a summary of the Quality

Section 1 - Site Overview

Version 1 May 2009

Section 3 – IPEC-PQG GMP Compliance Details:

Section 4 - Miscellaneous Site Information

Section 6 - Contact Information

III. Site And Supply Chain Security Overview

Version 1 May 2009

Section 2 - Supply Chain Security

Section 3 - Security Information

Version 1 May 2009

Section 4 - Safety & Environmental Information

Section 5 - Miscellaneous Site Information

Section 7 - Contact Information

Version 1 May 2009

Version 1 May 2009

PRODUCT REGULATORY DATASHEET

Section 1 – General Product Information

Section 2 – Manufacturing, Packaging, Release Site and Supplier Information

Section 3 – Physico-chemical Information

Section 4 - Regulatory Information

Compendial compliance and other regulatory status

Section 5 - Miscellaneous Product Information

Explanation of the lot/batch numbering system

Section 6 Revision history

Section 7 Contact Information

Version 1 May 2009

SITE QUALITY OVERVIEW

Section 1 Facility Overview

Section 2 - Compliance Evidence

Section 3 – IPEC-PQG GMP Compliance Details:

Quality Management Systems-Excipient Quality Systems (4)

Management Responsibility (5)

Resource Management (6)

Product Realization (7)

Measurement, Analysis and Improvement (8)

Section 4 Miscellaneous Site Information (Optional)