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:
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.
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.