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

Latest Issue

Latest Issue
PharmTech Europe

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

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.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here