Standardizing Excipient Information to Achieve Supply-Chain Security - Pharmaceutical Technology

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Standardizing Excipient Information to Achieve Supply-Chain Security
The use of various documents and guides by the International Pharmaceutical Excipients Council can facilitate the flow of information among excipient manufacturers, distributors, and users.


Pharmaceutical Technology
pp. s18-s21

Format of EIP documents

Each section of the EIP covers specific topics. The minimum information that should be covered in each section are defined; however, additional related information also can be provided at the discretion of the excipient supplier. If particular topics are not applicable to a particular excipient or site, it is indicated in the document. Where information is considered confidential, the document reflects how the excipient user can obtain this information. For example, the document may state that particular information may only be obtained under a confidentiality agreement.

EIPs do not require signatures (similar to material safety-data sheets, which also are not expected to be signed) as signatures do not add value or authenticity; however, they must be an official company document. Alternatively, a supplier may create a document that provides comprehensive details and explanations rather than immediately updating an EIP. The provision of the necessary information by the supplier by means of the EIP is more efficient than filling out specific individual customer questionnaires and surveys and the EIP usually has better, more complete information.

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 are used rather than names.

The EIP documents are 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, EIP template revisions, and notification to customers. The current version of the EIP Template and Guide can be found on the regional IPEC websites (see, http://ipecamericas.org/content/download-ipec-guidance-documents-here).

Application and use

The EIP documents are intended to provide useful information to individuals experienced and competent in the area of evaluating excipient suppliers and are not to be viewed as a replacement for audits. They may serve as pre-audit information to help prepare for a supplier audit so that the auditor's time at the site can be most effective. Although the documents are intended to form a complete package of information, each document within the EIP was designed as a stand-alone document. Some basic information, therefore, may be common among the documents.

To provide additional guidance on specific topics, IPEC–Americas maintains a Regulatory Reference Guide. The Regulatory Reference Guide lists links to the specific regulatory references applicable in different regions to various sections in the EIP documents. These references provide preparers of EIP documents detailed guidance on the information that needs to be included in the various sections. IPEC–Americas' Regulatory Reference Guide is accessible through the IPEC–Americas website ( http://www.ipecamericas.org/).


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