IPEC-Americas

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 submitted by pharmaceutical companies for completion by suppliers is immense and nonstandardized. 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 a 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 quickly and efficiently 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. 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 otherwise a labor-intensive activity and enables 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 4 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 preaudit 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 may, therefore, 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 the 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 to develop, submit for completion at defined frequencies, and track the return of completed questionnaires. Response times for EIP requests are shorter than those for traditional questionnaires. Depending on the 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 the information shared between the excipient supplier and the user is up to date. 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 updating 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 that 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 information is shared and how it is shared. Additionally, due to the manual nature of the process, “hand-completed” questionnaires are typically not incorporated into the excipient manufacturers' quality management systems.

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 of 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 the handling of this essential function to provide meaningful information rather than dedicating many hours to 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 preaudit 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, industrywide information requirements can easily be incorporated into the EIP.

Resource consumption from redundant activities can be minimized.

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 helps 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 EIPs throughout the industry to improve rapid information exchange, reduce costs, and improve timely distribution of key excipient information. Utilizing EIPs 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 of technical service at 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 the 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 Reynolds-Cummings is the regulatory and product stewardship manager at Evonik Corporation. Candy spent 15 years at GlaxoSmithKline, starting as an analytical chemist and QA validation manager in the OTC area (specifically oral care). She is currently working at Evonik as the regulatory and product stewardship manager for the Silica business line, supporting regulatory compliance in the US, Canada, and Mexico, and is the chair of the 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 health care business, as well as regulatory manager of the Dow Corning Healthcare Industries Materials Site. Kathy is a technical specialist for IPEC-Americas.

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.

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.

IPEC’s Excipient Information Package: A Standardized Communication Platform for Sharing Excipient Information as an Alternative to Questionnaires

Microcrystalline cellulose, refined wood pulp, texturizer, anti-caking agent, fat substitute, emulsifier, used in vitamin supplements or pills. | Image Credit: ©RHJ - stock.adobe.com

Note: This article has been updated by the authors to clarify examples of co-processed excipients.

The International Pharmaceutical Excipients Council (IPEC) defines a co-processed excipient as a combination of 2 or more compendial or non-compendial excipients designed to physically modify their properties in a manner not achievable by simple physical mixing, and without significant chemical change.

In some instances, formation of necessary components may occur, such as in situ salt formation.

In modern pharmaceutical formulations, co-processed excipients (CPEs) enable drug product manufacturability, stability, and performance that are not achieved when the CPE components are used individually in a simple blend. With the increased functional performance, formulators are turning to CPEs, which are engineered combinations of 2 or more excipient components integrated at the particle level (

Figure 1. "Simple" microcrystalline cellulose/fumed silicon dioxide blend (top right) compared to the co-processed silicified microcrystalline cellulose (bottom right).In co-processing, fumed silicon dioxide is added to microcrystalline cellulose slurry before drying creating an integrated system. Figure courtesy of the authors.

With the demonstrated benefits of CPEs in batch processing, it was a natural progression to their use in continuous manufacturing, which enables higher throughput and patient-centric dosage forms. Understanding the nature, benefits, and regulatory implications of CPEs is becoming indispensable for product formulators and supply chain decision-makers.

Historical Context and Current Prevalence of CPEs

The idea of co-processing is not new. The pharmaceutical industry has long used co-processed excipients. Several examples of co-processed excipients with a long history of use exist. One that is considered an early adoption of CPE use is the co-processed combination of carboxymethylcellulose sodium (NaCMC) and microcrystalline cellulose (MCC) grades developed (and introduced in the 1970s) to improve liquid delivery. Other widely used cellulose combinations such as MCC and lactose; lactose and powdered cellulose (both developed in the 1980s); and silicified microcrystalline celluloses (SMCC – developed in the 1990s) are examples where combining functional materials has produced practical benefits for decades. Today, more than 100 co-processed excipients exist, many of which are reported to be in commercial use, spanning direct-compression excipients, multifunctional binders, disintegrant-binder combinations, and specialty performance excipients, such as those used for orally disintegrating tablets (ODTs). Several of the co-processed materials identified above have achieved compendial recognition within the United States Pharmacopeia (USP). The growing number of CPEs reflects both historical safety experience and the practical manufacturing advantages they offer.

It is important to recognize that the individual components used in the manufacture of many CPEs are not isolated as single, compendial excipients prior to co-processing; however, they are carefully controlled. CPE manufacturers may employ different approaches to co-processing depending on the manufacturing processes used, components comprising the CPE, and the targeted physical and functional characteristics. In principle, there are 3 manufacturing pathways to produce CPEs. Each pathway yields an excipient whose composition is designed to work synergistically without significant chemical change to the components.

In practice, co-processing can be accomplished by several manufacturing routes:

Use of commercial excipients: Finished excipients are combined and subjected to a process (eg, milling, granulation, spray drying, or agglomeration) that integrates the components into particles comprising those materials (

A commercial excipient is introduced and combined with an in-process excipient that has not yet been isolated (eg, a polymer solution or slurry), and the combined stream is processed to integrate the components into particles comprising those components (eg, spray drying) (

All CPE components are in-process excipient streams coming together for co-processing: 2 or more material streams (eg, polymer dispersions, microcrystalline cellulose slurries, sugar-based solutions) are combined, mixed, and processed into particles without isolating any of the individual components first (

Figure 2. Commercial or finished excipients used to manufacture co-processed excipient. Figure courtesy of the authors. 

These manufacturing pathways affect physical characteristics, including particle morphology (particle shape and porosity), surface properties, particle size and size distribution, and moisture level, which in turn influence performance properties such as powder flow, compressibility, and robustness in the case of tablet manufacture.

Figure 3. Commercial or finished excipient(s) are added to the in-process stream of an excipient's manufacture during co-processing. Figure courtesy of the authors.

Figure 4. During excipient manufacture, the in-process streams are combined before drying to produce a co-processed excipient. Figure courtesy of the authors.

What Are the Safety and Regulatory Considerations?

An important safety consideration for CPEs is that no new covalent bonds are formed during co-processing, and that starting material chemical identities are preserved. Therefore, the individual component safety profiles are largely carried forward into the CPE. Because co-processing integrates components at the particle level, some attributes and interactions (eg, surface chemistry, dissolution rate, or microenvironmental pH) may change and should be evaluated.

One regulatory challenge arises when CPE manufacturers cannot claim straightforward pharmacopeial compliance for the co-processed excipient, and not all co-processed excipients have established compendial standards. This gap leads to an open industry question: Would broader pharmacopeial monograph coverage increase acceptance and adoption of CPEs? Many in the field insist yes — standardized monographs could improve transparency, harmonize quality expectations, and streamline regulatory reviews — but developing those monographs requires robust, widely accepted characterization methods for composite materials.

To adopt co-processed excipients responsibly, formulators and manufacturers should apply the following core principles:

Demonstrated safety. Confirm that the component identities and toxicological profiles are acceptable and that no unintended chemical reactions have created new risks.

Consistent composition. Ensure strict control of raw material attributes and manufacturing parameters to maintain reproducible CPE composition.

Reduced variability. Leverage co-processing to achieve more consistent performance from batch to batch versus simple blends.

Process control and monitoring. Implement robust in-process controls and validated manufacturing processes to maintain quality.

Documented performance benefits. Provide evidence that the CPE delivers functionality that cannot be achieved by simple mixtures.

Benefits for Manufacturing, Sustainability, and Innovation

Co-processed excipients provide a range of benefits that address both operational and formulation challenges, such as the following:

Facilitation of continuous manufacturing. CPEs can reduce the number of feeders and simplify input streams, improving feed-rate consistency and enabling more efficient continuous processes.

Sustainability. By reducing development iterations, waste from formulation trials and rejection during production, co-processed excipients can lower environmental impact. Some CPEs support direct compression, avoiding wet granulation and the associated solvent and energy use.

Productivity and cost. Enhanced flow, compressibility, and robustness reduce downtime, rework, and rejection rates, improving throughput and lowering the cost of goods.

Formulation enablement and innovation. CPEs can overcome flow or compaction limitations, reduce strain-rate sensitivity, allow capsule-to-tablet conversions, reduce binder needs, and enhance stability — opening pathways to novel dosage forms or improved patient-centric products.

Co-processed excipients are a practical, increasingly common resource for modern pharmaceutical development and manufacture. By integrating complementary excipient functions at the particle level, CPEs deliver real performance advantages that simple blends cannot match — from enabling continuous manufacturing and improving sustainability to solving difficult formulation problems. Continued development of compendial standards and transparent characterization will further support safe, consistent adoption of these materials across the industry. For formulators and manufacturers seeking reproducible, high-performance inputs, co-processed excipients merit serious consideration to accelerate development and improve product quality.

General glossary of terms and acronyms for pharmaceutical excipients. Version 3. IPEC; 2023. Accessed April 8, 2026. 

IPEC-Americas. Co-processed excipients demystified. 

. 2024;1(2):60-63. Accessed April 8, 2026. 

https://jefc.scholasticahq.com/article/124082-co-processed-excipients-demystified

Gina Marsee is the director, Compendial Compliance and Advocacy at Merck located in West Point, PA, USA. She holds a bachelor’s degree in Chemistry & Biology from the University of Tennessee and has worked in the pharmaceutical industry for 30+ years holding various leadership roles within Quality, Compliance, and Regulatory Affairs. She is also Chair, IPEC-Americas.

Ms. 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

Joseph Zeleznik is owner and president of Zeleznik Consulting.Previously, he was Technical Director – North America at IMCD US LLC. Joseph brings nearly four 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.

Candy Reynolds Cummings spent 15 years at GlaxoSmithKline starting as an analytical chemist and working up to QA Validation Manager in the OTC area (specifically oral care). Currently working at Evonik as the Regulatory and Product Stewardship Manager supporting the business line Silica for regulations in US, Canada, and Mexico.

Priscilla Zawislak is Corporate Regulatory Affairs, ROQUETTE AMERICAS, INC.
Priscilla has over 35 years’ experience in Regulatory Affairs and Quality for excipients, food additives and ingredients for personal care products. She is currently President of the IPEC Federation and the Vice Chair of Science and Regulatory Policy for IPEC-Americas and is also a past Chair of the organization.

Bob Sulouff is Sr. Manager Regulatory Affairs, Health & Pharma Solutions, ROQUETTE AMERICAS, INC. Bob has over 25 years’ experience in Regulatory Affairs and Quality, primarily focused on excipients. He is a member of Roquette’s Health and Pharma Solutions Regulatory team, where he advocates for value added pharma regulatory solutions. He is also Chair-Elect, IPEC-Americas.

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 and is currently the Chair of the IPEC-Americas QbD/Composition Committee.

Co-processed excipients (CPEs) are engineered combinations of two or more excipients integrated at the particle level to deliver functional performance unattainable through simple blending, without significant chemical change. Longstanding examples exist, and more than 100 CPEs are now reported in commercial use, including compendial materials. Manufacture can involve processing finished excipients together or co-processing in-process streams, shaping morphology and key attributes affecting flow and compressibility. Safety expectations hinge on preserved chemical identities, while regulatory adoption is constrained by limited monograph coverage and characterization standardization.

This article details what co-processed excipients are and how they are made.