Provisions of standardized excipient information
Because not all products are sent from the manufacturer directly to the end user, it is beneficial for a user to create distributors'
quality agreements when buying from distributors. Similar principles apply for distributors and manufacturers with regard
to information sharing. It is imperative that the distributor has similar agreements with its excipient manufacturers, particularly
with regard to change notification.
IPEC recommends the use of its guides (e.g, Quality Agreement, Excipient Composition, Excipient Qualification, EIP, Excipient GMPs, and Significant Change) for users to obtain information about the excipient distributor, manufacturer, and the excipient itself. The EIP is one of the best tools for sharing information using a standard format as it allows excipient suppliers to respond in a
timely and efficient manner to all requests as well as ensure that consistent and up-to-date information is provided.
The EIP User Guide explains the standardized excipients information package and is available at http://ipecamericas.org/content/download-ipec-guidance-documents-here. It is divided into the following sections:
Product regulatory datasheet: The product regulatory datasheet includes information that the maker and/or supplier provides regarding the product in general,
manufacturing, the packaging release site, supplier information, physicochemical information, regulatory information, revision
control, and contact information. This section would contain animal origin and raw-material sourcing information.
Site quality overview: The site-quality overview includes the site overview information, compliance evidence, IPEC–PQG GMP compliance details,
and miscellaneous site details.
Supply-chain security: Supply-chain security information includes the scope of the supply chain, details on supply-chain security, and specific
security information while the excipient is within the supplier's control, subject to agreements with, for example, the distributor,
and safety and environmental information.
IPEC–Americas encourages excipient suppliers to prepare and keep EIPs up to date for their excipients and to react proactively when alerts are issued for the latest concern or perceived threat.
By updating their EIPs and re-issuing them to their customers, much additional work is avoided by all parties, and patient safety is better ensured.
IPEC–Americas encourages excipient users to use information provided in the EIP format to obtain reliable details regarding the excipients they buy and their related supply chains by supporting the use
of a standardized format that facilitates open communication in a more efficient manner. Excipient users should always ask
their suppliers if they can provide them with an EIP document rather than requesting that suppliers fill out a questionnaire. Only if the excipient supplier declines to supply
an EIP should the excipient user send a questionnaire. By adopting such an approach, the entire paradigm for information exchange
between excipient makers, distributors, and excipient users will change and become much more productive for all parties while
ensuring that the best information is obtained by the user to be able to better control their drug product and ensure patient
1. FDA, Notification to Industry: Products Using Oils, Glycerin, or Protein That Were Derived from the Jatropha Plant May Have Toxic
Effects (Rockville, Md, July 6, 2012).
Bretta Erskine Lichtenhan is North American regulatory affairs manager, MM-Q Regulatory Services, Pharm Chemical Solutions, EMD Millipore, member of
the International Pharmaceutical Excipients Council (IPEC)–Americas Executive Committee and chair of IPEC–Americas Excipient
Qualification Committee, email@example.com