principles of validation to non-actives.

ALEXANDRIA, VA--Excipient makers are debating whether to apply validation principles to their products, as the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the

European Community
..... Click the link for more information. and individual members continue to discuss extending GMPs to all excipients excipients,
n.pl all the constituents of a remedy that lack medicinal properties. See also adjuvant, auxiliary substance, and vehicle.
..... Click the link for more information., especially in light of events--mostly in the 1990s--where hundreds of patients died due to deadly ingredients in drug products.

Members of the International Pharmaceutical Excipients Council International Pharmaceutical Excipients Council is a global organization representing producers, suppliers, and end users of excipients. The body has three divisions in Europe, Japan, and the United States, each of which focuses on local regulations concerning the excipients
..... Click the link for more information. of the Americas (IPEC IPEC International Programme on the Elimination of Child Labour
IPEC International Pharmaceutical Excipients Council
IPEC International Power Electronics Conference
IPEC International Power Engineering Conference
IPEC Integrated Petroleum Environmental Consortium
..... Click the link for more information.) met in Washington Sept. 11 to discuss an internal guidance to apply some level of validation to non-actives used in drug products.
Sidney Goode, project leader for Global GMP GMP (guanosine monophosphate): see guanine. SME (1) (Small and Medium-sized Enterprise) See SMB.

(2) (Subject Matter Expert) An individual who is well-versed in the policies and procedures of a particular department or division. for Dow Chemical, Harbor Beach, MI, and chair of the IPEC GMP Committee, wrote in an email: "The final guidance, if not called validation, will employ the principles of validation focused on providing process and systems that produce consistent quality products to market."

He said, "the scope is to include equipment, processes, methodology and computer systems." The "next project will be to guide the group in working with IPEC Europe to develop guidance defining the validation needs/requirements for the excipient excipient /ex·cip·i·ent/ (ek-sip´e-int) any more or less inert substance added to a drug to give suitable consistency or form to the drug; a vehicle.
ex·cip·i·ent
n. industry."

Goode said FDA FDA
abbr.
Food and Drug Administration

FDA,
n.pr See Food and Drug Administration.
FDA,
n.pr the abbreviation for the Food and Drug Administration. is involved in these discussions and the next meeting will be in December. David Schoneker, chairman of IPEC, and director of regulatory affairs at Colorcon, West Point, PA, said the trade group hopes to issue a document by the first quarter of 2008. IPEC recently provided members with a "Phase One Guideline" on the qualification of excipients used in drugs.

At an IPEC regulatory affairs conference that week, participants learned that there are more than 8,000 non-actives used in drug products worldwide, and that the various pharmacopoeias are approaching nearly 20,000 monographs.

Janeen Skutnik, director and team leader for compendial affairs and regulatory monitoring for Pfizer's European Service center, said firms are conducting "redundant, non value-added testing, that is providing no benefits to patients."

Goode also said there is a proliferation of master files at FDA, too. He said: "If you don't have to submit a drug master file Drug Master File or DMF is a document prepared by a manufacturer in the pharmaceutical industry and submitted solely at his discretion to the Food and Drug Administration (FDA). There is no requirement by law or FDA regulation to present a DMF. on one, please don't." FDAers at the meeting said they are trying to get a grip on the proliferation of master files.

Skutnik and other speakers said most excipient makers--at least the major and reputable ones--are "self regulating" and trying to apply facets of risk-based regulation and quality systems approaches used for active ingredients and finished drug products to excipients.

Skutnik said many firms are wise to look at ICH See Intel Hub Architecture. guidance documents Q8, Q9 and Q10 concerning quality systems.

FDAers said the agency will likely embrace the IPEC guidance for regulatory purposes. But Edwin Rivera-Martinez, chief of the Manufacturing Assessment and Pre-approval Compliance Branch in the Center for Drugs Division of Manufacturing and Product Quality, said that for FDA to devise guidance of its own is "difficult because there is a wide array of products."

He was largely referring to APIs, noting "there is wide diversity of API manufacturers. It is difficult to develop guidance for a specific industry and all excipients."

And, executives at the conference noted that when it comes to non-actives, often the same plants produce the same ingredients for foods and other products. In addition, makers of the finished dosage forms are largely held responsible for the excipients and APIs, and they are supposed to make drugs following GMPs.

By Ken Reid,