The early part of the 20th century was a time of incredible growth and achievement in the pharmaceuticals industry. Yet for all of the advances in medicine that have helped patients to overcome illness or improve the quality of their lives, tragedies also occurred. Patients lost their lives ingesting the very medications intended to help them due to adulterated or contaminated ingredients used in medicines. Clearly, some type of oversight of the pharmaceutical industry was badly needed.

In light of this need, the International Pharmaceutical Excipients Council (IPEC) was born. Like most organizations, it started slowly and modestly, but through the hard work and dedication of it's founding members the organization gained momentum. It soon became a worldwide presence focused on safeguarding drug product ingredients to protect the lives of individuals around the globe for over a quarter of a century, and will continue to do so into the 21st century and beyond.

Why IPEC is Needed

Under U.S. law, a new pharmaceutical excipient, unlike an active drug, has no regulatory status unless it can be qualified through one or more of the three approval mechanisms available for components used in finished drug dosage forms, e.g.:

> GRAS determination pursuant to 21 CFR 182, 184, and 186;

> approval of a food additive petition in 21 CFR 171; and

> as contained in an NDA approval for a specific drug product and for a particular function or use in that dosage form.

All three mechanisms are time consuming, inordinately expensive, and have become increasingly complex in recent years. None has a formal safety evaluation process or suitable approval process specifically for excipients.

In addition, varying national drug registration or approval systems and differences in excipient monograph specifications among the three major pharmacopoeias, the PhEur, JP, and USP make it virtually impossible to produce a single finished drug formulation that can be marketed on a global basis.

This situation is unlikely to change until:

> National drug approval systems are expanded to permit reasonable procedures for acceptance of new excipients and new excipient uses;beginning with how they are produced through recognized good manufacturing practices standards;

> An appropriate system exists for qualifying excipient suppliers and their products;

> Harmonization of compendial standards for more widely used pharmaceutical excipients is achieved among the major pharmacopoeias; and

> There is mutual recognition and mutual acceptance of pharmaceutical safety and effectiveness data from other national systems among the industrialized countries.

These, as noted in the IPEC-Americas Mission Statement, are major Council goals.

IPEC Guidance; How it Came about

In 1995, IPEC-Americas, IPEC Europe, and their member companies jointly adopted, published and implemented for the first time, industry developed good manufacturing practice standards for bulk pharmaceutical excipients. These were the result of a three-year effort in consultation with US and European regulatory authorities and their counterparts at the World Health Organization (WHO). This later led WHO to adapt the IPEC guidance for use by its national member states and, following release of updated IPEC guidance in 2001, for the United States Pharmacopoeia to include it as a general chapter in USP/NF, e.g., <1078>.

Later, beginning in 2003, IPEC-Americas and IPEC Europe entered into an arrangement with the Pharmaceutical Quality Group, an organizational unit of the Institute of Quality Assurance, an industry association headquartered in the United Kingdom, to produce appropriate new and updated standards for the manufacturing of excipients for pharmaceutical use. This was published jointly by the three participating organizations in January 2006 and is now being widely used on a global basis. World Health Organization authorities are reviewing the guidance to update present WHO guidance, and European Union regulators are considering its use as a standard to implement GMP requirements for certain excipients produced or sold in European Community countries. USP also has indicated that it intends to update its general chapter to include the new information.

Nearly 20 guidance documents on various subject have been produced by IPEC since 1995. Initially in print only, today all are available electronically—along with other publications— through the IPEC-Americas Public Library. IPEC will continue producing these documents to keep the excipient industry abreast of changing standards in order to facilitate dissemination of critical guidance.