Charlotte McIlvaine is senior manager-North America Pharma Quality at Univar Solutions. Charlotte is an analytical chemist experienced in quality control and quality assurance. Charlotte joined Univar Solutions over 9 years ago to oversee quality in 2 districts focusing on the quality needs for Univar Solutions’ pharmaceutical customers.

Charlotte McIlvaine 

Scientist Examining Medical Documents Near Ampoules and Pills | Image Credit: ©PixelPulse-stock.adobe.com

Traditionally, supplier questionnaires from pharmaceutical companies have been an essential part of most quality management systems to ensure that information related to an ingredient and its supplier is documented. This information can include almost anything from the raw materials used in manufacturing to packaging materials as well as the distribution channels used for sourcing. Questionnaires have historically been used to assist excipient users with qualifying and periodically reassessing a supplier’s potential risk. Questionnaires present numerous challenges, including those related to time requirement for completion, consistency with the information shared, and the ability to have version control. The sheer number of questionnaires that are submitted by pharmaceutical companies for completion by suppliers is immense and non-standardized. Conversely, the number of questionnaires to which suppliers must respond as well as the varied questionnaire formats submitted exacerbates the challenge. This often results in slowed response times, decreased information accuracy, and non-value-added increased workload. To overcome the challenges, the International Pharmaceutical Excipients Council (IPEC) has established the Excipient Information Package (EIP) User Guide and Templates to streamline information exchange, reduce response times, and increase accuracy through a standardized information sharing format.

IPEC’s EIP addresses the most commonly requested information by clearly articulating the type and level of information that users need to support use of the excipient. EIPs and the associated templates are also organized in a standardized format that can be shared efficiently, quickly, and updated easily. The EIP has another benefit; the ability for excipient makers to update excipient users with changes that may affect a previously completed questionnaire, keeping key information current.

The EIP is not new. First introduced 20 years ago, the EIP continues to improve as the scope of requested information evolves. For instance, in 2023 a new section on sustainability was included. More importantly, EIP development is, and has been, a collaborative effort among excipient stakeholders, specifically manufacturers, distributors, and users. Since its inception, the EIP has undergone some modest changes while maintaining a standardized approach to information sharing. Further, the EIP has been adopted globally, making it easier to share information internationally.

Key benefits of the EIP include the following:

Excipient users can receive complete information in a standardized format to support their regulatory filings.

Change control is facilitated through periodic reviews and updates.

The opportunity for electronic-data transfer makes information exchange more effective and efficient.

Streamlines what is an otherwise labor-intensive activity and allows for quick delivery of information to the user.

Distributors can respond to information requests expeditiously and independently while ensuring consistent, accurate information.

EIP document templates, currently in four parts, are designed to provide relevant information to individuals experienced and knowledgeable with excipient supplier evaluation. The EIP is not intended to replace audits. EIP review may serve as pre-audit preparation to assist with a supplier audit, particularly if it is the first time visiting an excipient manufacturing site. The EIP documents are intended to generate a detailed comprehensive information package. Each EIP part or section is designed as a standardized, stand-alone document that addresses information requests typical of questionnaires. Some information, therefore, may be common among the documents.

Part I: Product Regulatory Datasheet. The Product Regulatory Datasheet is designed to communicate important physical, manufacturing, and regulatory information specific to the excipient.

Part II:Site Quality Overview. The Site Quality Overview is intended to communicate a summary of the quality systems and good manufacturing practices/good distribution practices used to manufacture/distribute the excipient(s) at a particular site or sites.

Part III:Supply Chain and Security Overview. The Supply Chain and Security Overview is designed to provide users with information concerning the product supply chain from manufacturing site through delivery to the user site, including security of the product.

Part IV: Sustainability Guide. The Sustainability section facilitates the communication of the excipient supplier's information on sustainability policies and related matters.

What Is the Value of the EIP to Stakeholders?

An accurately prepared EIP is dependent on a suitable interpretation of IPEC’s Excipient Information Package User Guide and Template, commonly referred to as the EIP Guide. A regulatory reference page is provided on the IPEC–Americas website (https://ipecamericas.org) to assist excipient manufacturers with preparing EIP documents.

The EIP provides an efficient process for sharing information compared with completing a questionnaire, which is labor intensive and time consuming. Many companies have elected to maintain EIPs on their company website, making the retrieval process even more efficient.

The EIP streamlines the sharing of information for excipient maker, distributor, and user by eliminating the need for developing, submitting for completion at defined frequencies, and tracking the return of completed questionnaires. Response times for EIP requests are shortened compared to traditional questionnaires. Depending on receipt of the information request, the EIP can typically be furnished within 24 to 48 hours or less. Questionnaires, on the other hand, can take months from receipt to return and may not be complete. Missing or inadequately completed questionnaires can delay supplier or excipient qualification, which can delay drug product development, manufacture, and commercialization.

It is important that information shared between excipient supplier and user is current. The EIP offers an important advantage over completing traditional questionnaires in this regard. Because the EIP can be integrated into the excipient supplier’s change management process, updates to the EIP, when required, become routine. Although requested by pharmaceutical companies, questionnaires provide no mechanism for update in the event of changes by the excipient manufacturer. The EIPs are version controlled, with an established revision process to ensure that information provided in the EIP remains current. EIPs are standardized similar to a Safety Data Sheet, which facilitates preparation, maintenance, and use of information.

What Is the Benefit to Excipient Manufacturers?

EIPs offer significant benefit to excipient manufacturers as well. The challenge of receiving, completing, and returning numerous customer questionnaires is time consuming and labor intensive. Aside from differences in questionnaire formatting, questions can be vague, difficult to interpret, or not applicable to excipients. The level of information requested can be as simple as yes/no to providing detailed information which may have limited value to the user. The result is often incomplete questionnaires or sharing incorrect or irrelevant information. When questionnaires are completed by multiple individuals within an excipient company, there can be inconsistencies in what and how information is shared. Additionally, due to the manual nature of the process, “hand-completed” questionnaires are typically not incorporated into the excipient manufacturers' quality management system.

The EIP was designed and developed by subject matter experts to expedite information sharing, transforming the process from inadequate to a system of reliable, peer-reviewed documents that are managed within the quality management system. EIP’s can easily identify confidential information that would need to be shared by an NDA or a drug master file (DMF). As such, excipient users can be assured that EIPs are prepared and internally reviewed for accuracy by qualified personnel.

What Are the Benefits to Distribution Channels?

Increasingly, excipient supply chains rely on distribution channels, particularly for smaller pharmaceutical companies. Distributors routinely facilitate the delivery and follow-up of customer questionnaires for internal use and between their suppliers and customers. This process consumes numerous resources and creates delays for the customers. The supplier EIP can directly provide excipient-related information to all customers rather than requiring the distributor to complete and route customer specific documentation.

EIP streamlines handling of this essential function to provide meaningful information rather than dedicating many hours tracing a single questionnaire. Increasingly, upon receipt of a questionnaire from a distributor, the excipient manufacturer can respond in a timely manner with a product-specific EIP. The EIP provides direct information from the supplier on the supplier’s letterhead ensuring direct transfer of information without interpretation or additional information from the distributor.

The EIP provides the type of information users require to support their intended use. This information is provided directly to the user in an efficient manner, preventing delays typically seen with questionnaires. EIPs are document-controlled with periodic review. Changes are managed through revision history and version control. 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 excipient user.

Other benefits of the EIP process include the following:

The EIP can be used as pre-audit information to facilitate the audit process. However, EIPs should not be used in place of performing audits.

Excipient users can easily compare suppliers because information is provided in a common, standardized format.

Users can quickly identify changes by reviewing EIP revision history.

New, industry-wide information requirements can easily be incorporated into the EIP.

Minimize resource consumption from redundant activities.

IPEC’s Excipient Information Package User Guide and Templates facilitates a streamlined, consistent approach to information sharing among stakeholders (excipient manufacturers, distributors, and pharmaceutical companies). The EIP provides information using an international standardized format and addresses the requirements common to many questionnaires. EIPs shorten response times which help expedite supplier qualification. EIPs are not a substitute for audits but can help with audit preparation and risk assessment. The EIP facilitates the rapid exchange of key excipient information throughout the supply chain. The EIP content is routinely updated and managed with version control.

The IPEC EIP was developed as a means of efficiently communicating a significant amount of information about the excipient (Part I), the excipient manufacturer (Part II) and the distribution and supply chain (Part III), and sustainability (Part IV).

 The information provided facilitates and aids the excipient user in their qualification of the excipient supplier and the excipient.

IPEC Americas encourages the use of EIP’s throughout the industry to improve rapid information exchange, reduce costs, and improve timely distribution of key excipient information. Utilizing EIP’s would be a significant improvement over the use of customer questionnaires to obtain necessary information. The EIP Guide and Templates are available for no charge by visiting the Public Library of the 

IPEC Federation announces the revised IPEC Excipient Information Package Guide. IPEC Federation. Accessed June 23, 2026. 

https://ipec-federation.org/ipec-federation-announces-the-revised-ipec-excipient-information-package/

Regulatory references. IPEC Americas. Accessed June 23, 2026. 

https://ipecamericas.org/reference-center/regulatory-references

Guidelines. IPEC Federation. Accessed June 23, 2026. 

Joseph Zeleznik is director, Technical Service; IMCD US LLC. Joseph brings nearly 4 decades of experience in pharmaceutical excipient and formulation development. His expertise spans high-functionality and novel excipients, continuous manufacturing, and advanced formulation strategies. Additionally, he is a member of IPEC-Americas Executive Committee, currently serving as Immediate Past Chair.

David R. Schoneker is currently the president/owner of Black Diamond Regulatory Consulting, LLC, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food, and related industries. Dave has been involved in the excipient industry for over 48 years. He is a former Chair of IPEC-Americas and is currently the Chair of the IPEC-Americas QbD/Composition Committee.

Candy Reyolds-Cummings is Regulatory and Product Stewardship Manager at Evonik Corporation. Candy spent 15 years at GlaxoSmithKline starting as an analytical chemist, QA Validation Manager in the OTC area (specifically oral care). She is currently working at Evonik as the Regulatory and Product Stewardship Manager supporting the business line Silica for regulations in US, Canada, and Mexico and is the Chair of IPEC-Americas Excipient Qualification Committee.

Katherine Ulman is the owner and Primary for KLU Consulting, LLC. She retired from Dow Corning Corporation after more than 40 years of employment. While at Dow Corning, she held positions as a global regulatory compliance manager for their healthcare business as well as regulatory manager of the Dow Corning Healthcare Industries Materials Site. Kathy is a Technical Specialist for IPEC-Americas.

Articles

Supplier questionnaires remain central to pharma quality systems but are increasingly inefficient due to nonstandard formats, high volume, slow turnaround, inconsistent responses, and weak version control. IPEC’s Excipient Information Package (EIP) offers a standardized, globally adopted, document-controlled alternative that accelerates information exchange, supports regulatory submissions, and integrates with supplier change management. The EIP comprises four modular templates covering product regulatory data, site quality systems, supply chain/security, and sustainability. It streamlines qualification workflows for manufacturers, distributors, and excipient users while complementing, not replacing, audits.

IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.