IPEC Federation to Unify Excipient Usage and Standards

This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

PharmTech: What was the rationale for creating a global IPEC Federation?

Patricia Rafidison, IPEC Federation Chair

Rafidison: The foundation of an IPEC Federation was a natural evolution of our former TRIPEC group (IPEC of the Americas, Europe, and Japan). The number and types of subjects to be discussed regarding excipients have impact beyond the scope and boundaries of the original TRIPEC regions. The IPEC Federation will serve as the forum to address international or intercontinental issues, policies, and standards for excipients.

PharmTech: Last year, IPEC–Americas Chair and new Vice-Chair of the IPEC Federation Janeen Skutnik noted that priority areas for the federation would include: harmonization, heavy metals, risk management/contingency issues, supply-chain security (including counterfeiting), managing global regulatory expectations, and certification. Have these goals changed? Can you briefly address how the federation plans to work in each area?

Rafidison: These priorities have not changed. Harmonization of excipient monographs remains a key focus for the federation, and we are continuing to strengthen our interactions with the Pharmacopeial Discussion Group (PDF, which represents the pharmacopeias of Europe, Japan, and the US) to drive complete harmonization of excipient monographs, rather than standardizing individual attributes. Supply-chain security is high on our agenda because traceable and safe sources of excipient supply are a given expectation from regulators and patients alike. Our global certification project is one way to help mitigate that risk (see details on the certification program). However, that initiative is strongly dependent on harmonized regulatory expectations globally. The federation will address these issues by creating specific international project teams and committees as needed.

PharmTech: IPEC is working with the Product Quality Group (PQG) to update standards for auditing excipient suppliers. What is the status of this initiative?

Across the regions: The International Pharmaceutical Excipients Council

Rafidison: IPEC has had a long association with PQG in the United Kingdom, which resulted in the publication of an IPEC–PQG good manufacturing practice (GMP) guideline for excipients. PQG is a partner in the certification project, Excipact, and will contribute to updating the excipient GMP guide, which will be used as a standard for certification. [Note: Excipact wil provide certification to eexcipient GMP and GDP conformance using an annex to ISO 9001 and approved third-party audit programs to issue certifications.] The certification team is planning its launch for the end of 2010 or early 2011.

PharmTech: Does the federation plan to work directly with national regulatory agencies as well as global organizations such as the World Health Organization (WHO)? If so, in what capacity?

Rafidison: Each IPEC organization is the 'voice of excipients' in a specific country or region and has its own set of issues and regulations to address; this has to be respected and will not change. The IPEC Federation will contribute and interact with regulatory agencies, WHO, and industry partners proactively via the regional IPECs, with the Federation providing the platform to attain globally harmonized positions on excipient matters.

PharmTech: How do you foresee the federation, as a unified global voice, helping to improve excipient standards and quality?

Rafidison: By choosing the right priorities, and continuing the dialogue beyond our current global reach, we should be able to build appropriate plans to influence and improve excipient quality standards and to better protect public health. Speaking with a unified voice, we will have greater impact as our goals are not only to develop common guides but also to communicate and train key stakeholders to mitigate risk. That will be our challenge and remains a key part of our mission.

PharmTech: As the first IPEC Federation chair, what do you envision for the federation in the coming years?

Rafidison: In the short term, our key objective is to set up our operating policies, procedures, and practices to allow us to deliver our mission, and be the recognized organization for all matters related to pharmaceutical excipients. Each regional IPEC continues to provide resources to support our strategies, with a key focus on our common projects as stated previously.

PharmTech: How will the federation's chairmanship work?

Rafidison: The chairmanship will rotate through the various IPEC regions and have a term of at least one year. The Board of the IPEC Federation is charged with establishing rules for the election of the chair and other officers.

PharmTech: Can you describe some of the other federation logistics such as whether there will there be a federation office and staff, and how often the group will meet?

Rafidison: The offices of the federation's secretariat are located in Brussels and the federation is registered as an association in Belgium. The Board will meet face-to-face at least twice a year (the next meeting will be in Tallin, Estonia, in June 2010), and in the interim periods via teleconference. All Board positions are voluntary. A dedicated website will be established in the near future to interface with all IPEC member sites.

PharmTech: Does IPEC have plans to establish additional regional organizations beyond the current four (Americas, Europe, China, and Japan), and if so, what is the timeframe?

Rafidison: It is in our intention to continue to grow membership of the IPEC Federation to increase global representation. As we identify potential candidates, the Board of the Federation will consider them for admission.