DOC

IPEC EIP: Template & User Guide 2009

By Jack Daniels,2014-08-09 17:26
8 views 0
The IPEC Excipient Information Package (EIP): Template and User Guide 2009 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.

The 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 Japan PEC). 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

    SuppliersUsers

    IPEC

    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.

    Copyright ? 2009 The International Pharmaceutical Excipients Council

    Page 2 of 24

    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

    Copyright ? 2009 The International Pharmaceutical Excipients Council

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.

    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

    Copyright ? 2009 The International Pharmaceutical Excipients Council

    Page 4 of 24

    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.

    Copyright ? 2009 The International Pharmaceutical Excipients Council

    Page 5 of 24

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.

    Topics for this section:

     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.

    Topics for this section:

     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)

    Copyright ? 2009 The International Pharmaceutical Excipients Council

    Page 6 of 24

    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.

    Topics for this section:

     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.

    Topics for this section:

     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.

    Copyright ? 2009 The International Pharmaceutical Excipients Council

    Page 7 of 24

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.

The following sections are expected to be included in the document unless otherwise

    specified.

Section 1 - Site Overview

    The purpose of this section is to describe the supplier’s organization and production capabilities.

    Topics for this section:

     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

    Copyright ? 2009 The International Pharmaceutical Excipients Council

    Page 8 of 24

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)

Section 5 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.

Section 6 - 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.

    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.

The following sections are expected to be included in the document unless otherwise

    specified.

    Copyright ? 2009 The International Pharmaceutical Excipients Council

    Page 9 of 24

    Section 1 - Scope

    The purpose of this section is to identify the manufacturing site and distribution site(s) (where applicable) covered by this document.

    Topics for this section:

     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.

    Topics for this section:

     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.

    Topics for this section:

     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

    ; Pre-employment background checks

    Copyright ? 2009 The International Pharmaceutical Excipients Council

    Page 10 of 24

Report this document

For any questions or suggestions please email
cust-service@docsford.com