A little over 18 months since it was established, the strategy and work programs of the International Pharmaceutical Excipients
Council (IPEC) Federation have started to take shape. The federation's overall focus is to provide expertise on excipient
regulatory and scientific issues, to assist in the harmonization of quality standards, and to promote global supply-chain
Originally formed with representatives from the four existing IPECs—IPEC-Americas, IPEC–Europe, IPEC–Japan (JPEC), and IPEC–China—the
IPEC Federation is set to add IPEC-India to its membership. The federation also has formed partnerships in Latin America through
trade associations in Brazil and Argentina and has a partnership with Mexico in the works. The following section summarizes
recent progress made by the organization to date.
One of the federation's priorities is the global harmonization of excipient monographs. The organization has been working
in partnership with the Pharmacopoeial Discussion Group (PDG), which brings together experts from the US, European, and Japanese
pharmacopeias. The two groups met in June 2011, and made progress on several fronts, including the inclusion of additives
in pharmacopoeia monographs, where additives are typically present in commercially available materials, as well as standardization
of methods for measuring viscosity of cellulosics. An IPEC working group will continue to consult within an industry coalition
and plans to run a global workshop on viscosity of cellulosics to develop recommendations for discussion with PDG.
Recognizing that additives can be components in excipients is a major step-forward and work is ongoing to compile a comprehensive
list of additives and processing aids that are typically used in the manufacture of excipients. The goal is to collaborate
with regulatory authorities, including FDA, to find a way to "grandfather" the permitted inclusion of such components in specific
excipients where their historical and safe use can be demonstrated and justified.
One of the biggest projects undertaken since the formation of the IPEC Federation in 2010, is to support the third-party excipient-certification
program known as EXCIPACT. The program is designed to complement other third-party schemes such as the ANSI-accredited International
Pharmaceutical Excipient Auditing (IPEA) program set up by IPEC–Americas. The auditing program provides certification that
an excipient manufacturer meets IPEC–Pharmaceutical Quality Group (PQG) Excipient GMPs. EXCIPACT will provide an equivalent
certification for companies who already may be certified to ISO–9001, the international standard for quality-management systems,
but that need their certification expanded to cover the additional requirements for excipient GMPs and good distribution practices
(GDPs). The latter standards go beyond ISO–9001 to include requirement for contamination control, document traceability, cleaning,
training, and so forth.
GMP and GDP legislation for excipients has been proposed in both Europe and the United States. As a result, excipient suppliers
could be faced with an avalanche of quality audits and related requests to ensure customers and regulators that their facilities
and products meet these new requirements. Excipient users will need to find a way to obtain physical audit information on
every supplier they use and that cannot be done with available in-house audit resources.
Industry experts from the European Fine Chemicals Group (EFCG), IPEC–Europe, IPEC–Americas, PQG, and the European Association
of Chemicals Distributors (FECC) developed the EXCIPACT certification scheme to provide industry with an alternative means
to obtain independent assessment of manufacturers and suppliers of pharmaceutical excipients. Most suppliers are already ISO-certified,
meaning that they meet a defined set of GMP and GDP standards. EXCIPACT and IPEA are two pathways that IPEC will be offering
to achieve the same level of certification as ISO—one for companies that are already ISO-certified and one for companies that
are not ISO-certified and want to go through a full certification to excipient GMPs.
IPEC–Japan recently established Self-imposed Standards for Manufacturing Control and Quality Control of Pharmaceutical Excipients
and its Explanation. The English version of these standards will be published in 2011. IPEC–Japan also began a third-party
certification system in 2005.
These programs demonstrate that excipient suppliers, distributors, and the pharmaceutical industry are fully committed to
the use of high quality excipients and ensuring their integrity throughout the supply chain. The use of EXCIPACT and the
IPEA certification schemes add a significant contribution to ensuring patient safety and supplier quality, while minimizing
overall supply-chain costs.