The Excipient Information Package, A Win-Win Solution

The EIP process addresses the problems encountered with numerous questionnaires when qualifying excipient manufacturers.
Nov 02, 2007
Volume 31, Issue 11

Excipient questionnaires have long been a thorn in the side of quality groups. Covering everything from feedstock used in the manufacturing process to distribution channels, questionnaires are meant to help an excipient user qualify a vendor or an excipient based on potential risk. Although a necessary and worthwhile endeavor, questionnaires present their own set of challenges.

Excipient questionnaires

The Standardized Excipient Information Package (EIP) Protocol and EIP.
The challenge in completing excipient questionnaires is that every excipient user has a unique survey format. Vendors are not only overwhelmed by the number of questionnaires to which they must respond, but the varied survey formats further compound the challenge. The end results are slow response times and a loss of data integrity.

Quality groups cite other challenges in using surveys for information gathering. Questionnaire items are often focused on active pharmaceutical ingredients instead of excipients. The Standardized Excipient Information Package (EIP) Protocol clearly defines the level of information required at the excipient level.

Change control is another concern. The manufacture of excipients is an evolving industry. The absence of a standardized format impedes the excipient makers' ability to update excipient users of changes that may affect a previously completed questionnaire. This situation affects the integrity of the information transferred.

A solution for information gathering

In early 2006, the International Pharmaceutical Excipients Council (IPEC) addressed the industry-wide dilemma of data integrity by issuing its EIP Protocol. The development of the EIP Protocol was a joint effort of excipient users and makers. The EIP Protocol is now being used by individual excipient makers to create their own EIPs.

Some benefits that may be derived from an industry-wide standardized excipient information process include:

  • Excipient users have the ability to receive complete data in a standardized format
  • Change control is facilitated through periodic reviews
  • The opportunity for electronic-data interchange makes information gathering more pliable and efficient.

Applying technology to what has historically been a labor-intensive process allows excipient makers an opportunity to provide important information to excipient users in real time. Distributors are better able to ensure the integrity of the excipients they supply and the manufacturers they represent.

The value of an EIP

The EIP concept was developed with the primary objective of providing industry standards for the transfer of information from excipient maker to user to simplify and improve the process. It was developed using the collective wisdom of the maker, user, and regulatory communities. Numerous global pharmaceutical company questionnaires were reviewed as part of the development process. Information was included based on the pharmaceutical industry's need for the information.

Regulatory reference page. An accurately prepared EIP is dependent on a correct interpretation of the EIP Protocol. A regulatory reference page is provided on the IPEC–Americas website (ipecamericas.
org) to assist maker companies in preparing the EIP. The regulatory reference page is periodically reviewed and updated as necessary.

Information transfer. The EIP is a very efficient process for the transfer of information as compared with completing a questionnaire. Some companies have elected to maintain the EIP on a website, making the process even more efficient in terms of human resources. Increased efficiency of the process offers an opportunity to potentially reduce the cost of pharmaceuticals for the patient.

The EIP process streamlines the supplier information process for the user by eliminating the work process of developing supplier questionnaires, sending a copy to suppliers at defined frequencies, and tracking the return of completed questionnaires from the suppliers. Turnaround time for EIP requests is remarkably improved vis-à-vis questionnaires. The EIP is often furnished on the same day as the request. Questionnaires, on the other hand, often take many months to receive and may not be fully completed. Missing or improperly completed questionnaires delay the approval process for materials and suppliers.

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