The Excipient Information Package, A Win-Win Solution - Pharmaceutical Technology

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The Excipient Information Package, A Win-Win Solution
The EIP process addresses the problems encountered with numerous questionnaires when qualifying excipient manufacturers.


Pharmaceutical Technology


It is important that information transferred from excipient maker to user is and remains current. The EIP offers an important advantage over completing a questionnaire in this regard. Because the EIP is integrated into the excipient maker's management of change process, maintaining the accuracy of the EIP relies upon a properly functioning quality system. Although sometimes requested by excipient users, questionnaires provide no mechanism for update in the event of changes. The EIP Protocol and the EIP are version controlled, with an established revision process for the EIP Protocol to ensure that information provided in the EIP remains current.

EIP format. The EIP is provided in a standardized format similar to a material safety data sheet, which facilitates preparation, maintenance, and use of the information. The EIP documents are meant to be used by individuals experienced and competent in evaluating excipient suppliers and are not intended as a replacement for audits. The EIP Site Quality Overview, however, may be used as an adjunct to audits for vendor qualification and ongoing assessment. Additionally, the Site Quality Overview could minimize the time needed for an onsite audit. By serving as a conduit to notify excipient user companies of changes, maintenance of an EIP may reduce the frequency of on-site audits under appropriate conditions.

Excipient manufacturers

From the excipient manufacturer's perspective, the challenge of receiving, completing, and returning numerous customer questionnaires is daunting. Each questionnaire is formatted differently. Questions are sometimes difficult to understand and therefore, difficult to answer properly. Most importantly, because of the manual nature of the process, the hand-completed documents are typically not incorporated into the excipient manufacturers' quality management system.

The EIP concept was developed as a way to elevate the transfer of information from supplier to customer (maker to user) from an inadequate process to a system of reliable, peer-reviewed documents that are managed with the quality system.

The EIP is an integral part of the excipient maker's quality management system. As such, users can be assured that EIPs are prepared by qualified professionals and are internally reviewed for accuracy. EIPs are document-controlled with periodic review, and any changes or updates are managed through revision history and version control. The integration into the quality management system and the management of change process ensures that the EIP is always current and meets the needs of the intended target marketplace.

There are other benefits of the EIP process. These include:

  • Users can easily compare suppliers on an equal basis because suppliers provide information in a common format
  • Users may request EIP updates on an ongoing basis
  • Users can quickly identify changes by reviewing the EIP's revision history
  • New industry-wide information needs can be incorporated into the EIP Protocol.

Distributors

Although supplier-information requirements are the same for both large and small pharmaceutical customers, it can be difficult to obtain the completed questionnaires necessary to qualify an excipient if volume history or potential is minimal. Distributors routinely facilitate the delivery and follow-up of their customers' questionnaires. The volume of work associated with this customer-service function requires significant resources. The EIP permits the resources that handle this critical customer-service function to provide meaningful information instead of spending hours tracing the whereabouts of a single questionnaire. Increasingly, upon receipt of a questionnaire from a distributor, the targeted manufacturer is able to respond in a timely manner with a product-specific EIP.

Future vision

The future vision of the EIP process is that, as new requirements come along, the EIP Protocol will be updated accordingly. Although IPEC–Americas has led the development of the EIP process, the goal is to harmonize globally, which will further enhance the benefits of the process. The International Pharmaceutical Excipients Council Europe will publish the harmonized version of the EIP Protocol in early 2008. The EIP Protocol for use in Japan will be published by the Japan Pharmaceutical Excipients Council in the fourth quarter of 2007.

David Klug is senior manager of GMP at sanofi-aventis US LLC,
and member of the executive committee of the International Pharmaceutical Council of the Americas (IPEC–Americas). Ann Van Meter is a senior quality system specialist with Dow Chemical Company, and Laura Horne is the US account executive (Southeast) for Mutchler Ingredients. All three authors are members of the excipient qualification and GMP committees for IPEC–Americas.


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