The pitfalls of questionnaires and surveys
Regulatory bodies make no statements regarding any regulatory requirements for suppliers to respond to questionnaires and
surveys for their customers. Additionally, many excipient suppliers sell only a small amount of their products into the pharmaceutical
market and may have little interest in supplying any type of nonstandardized information to pharmaceutical users. Excipient
users typically send detailed questionnaires and surveys to obtain information using their own individual formats, which makes
answering these questionnaires difficult for the excipient manufacturer.
The excipient supplier must carefully read each user inquiry to try to interpret the intent of the user's question, which
may or may not relate to the supplier's specific excipient. This situation is obviously more difficult when a language barrier
exists. Completion of questionnaires and surveys is time-consuming due to their length and complexity as well as the numbers
received by the supplier in all different formats. Furthermore, because these surveys and questionnaires are specific to a
particular user, it is impossible for the excipient supplier to identify which responses to inquiries are affected by a change
in their operations, and therefore, which customer to alert to the change. Significant resources are expended, both by the
user and supplier, to send, complete, return, review, and track these questionnaires and surveys. Finally, for each instance,
these responses are a one-time activity and would rarely be updated by a supplier when something changes because these are
not the supplier's own documents.
Use of the EIP for such information provides not only a document controlled by the excipient manufacturer but also ensures that the pharmaceutical
customer will be provided with each revision. The nature of the EIP, as a dynamic, controlled document with a revision history that is continually updated to address new issues as they arise,
supports and benefits both suppliers and users. The EIP allows both parties to have the most current document from which to make assessments of their excipients. Changes to the
EIP result in a formal revision and notification to the customer.
The primary goal of the EIP is to provide a standard template for the exchange of information between excipient suppliers and users to simplify the process
of information exchange. By responding to surveys, questionnaires, and other requests for information using the standard format
outlined in the EIP, excipient suppliers can respond in a timely and efficient manner to all such information requests as well as ensure that
consistent information is provided and revisions are tracked. The most appropriate course of action when an emerging issue
arises should include notifying IPEC-Americas so that the EIP can be updated, if appropriate.
Excipient users will be able to anticipate the type and format of the standard data packages they receive from their excipient
suppliers when using the EIP. This approach will assist users and suppliers in the management of such information. In the
future, electronic transmission of such data packages for direct download may be possible. Additionally, such standardization
will facilitate the necessary change notifications pertaining to previously supplied information, thereby further strengthening
the excipient suppliers' change-notification program and the excipient user's knowledge and understanding of their excipients
and the sources of the excipients.