International Pharmaceutical Excipient Council

International Pharmaceutical Excipients Council (IPEC) guidelines, 21 168, 169 International Programme on Chemical Safety (IPCS), 18 540-541 International Society of Blood Transfusion (ISBT), 12 151... 

According to the International Pharmaceutical Excipients Council, the following are the most commonly used excipients in the United States ... 

GAMP4, IPEC, International Pharmaceutical Excipients Council, 2002 (http //www.ipec.org). 

International Pharmaceutical Excipients Council (IPEC) (2006), Good Manufacturing Practices, IPEC, Washington DC. 

Abbreviations. FDA, Food and Drug Administration IPEC, International Pharmaceutical Excipients Council ADME, adsorption, distribution, metabolism, and excretion. 

Efforts to create mechanisms for obtaining some indicia of regulatory acceptance of excipients have been more successful. One notable effort by industry along these lines was the creation of the International Pharmaceutical Excipients Council (IPEC) in 1991. IPEC was formed to represent the interests of both excipient manufacturers and users (pharmaceutical companies), and is notable for a number of initiatives on behalf of the industry these include the following ... 

Table 3 indicates the preclinical safety studies for CAPTISOL (25) conducted as of 2005. The strategic safety plan for CAPTISOL was designed based on the guidelines discussed in the 1990s by the International Pharmaceutical Excipients Council which resulted in the May 2005 issuance of the FDA Guidance (26) Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients. These studies and others in the CAPTISOL Drug Master File have delineated the safety of CAPTISOL (SBE7-P-CD) for parenteral, ophthalmic, oral, nasal, and inhalation administration. 

Blecher L. The formation of the International Pharmaceutical Excipients Council. Pharm Technol 1991 15(6) 54, 56. 

Tableting process, since being introduced in the early 1840s, has witnessed numerous changes in the form of stringent regulatory requirements for the excipients and product stability. Increasing regulatory pressure on purity, safety, and standardization of the excipients has catalyzed the formation of an international body, the International Pharmaceutical Excipients Council (IPEC) (13). IPEC is a tripartite council with representation from the United States, Europe, and Japan, and has made serious efforts to harmonize requirements for purity and functionality testing of excipients (14).

This chapter will deal with the objective of manufacturing excipient ingredients to appropriate good manufacturing practices (GMP) requirements, as stipulated by the United States Pharmacopeia (USP) (1) and the International Pharmaceutical Excipients Council excipient GMP guide (2). It is beyond the scope to address the many quality techniques for minimizing variation in excipient quality. However this chapter will address the issues concerning assurance that all excipient material within each batch meets compendial or manufacturer s specification. 

Excipients are used in drug substance formulations to provide an acceptable drug product. The FDA considers excipients as BPCs, but has not issued specific GMP regulations for them. The International Pharmaceutical Excipient Council (IPEC), however, issued a proposed GMP for excipients in 1995 and a guide, Significant Change for Bulk Pharmaceutical Excipients BPEs, in the year 2000. 

The International Pharmaceutical Excipient Council in the United States (Arlington, Virginia 703-521-3338) has issued a GMP guideline for excipient bulk pharmaceutical chemicals. In conjunction with both the European and Japanese Pharmaceutical Excipient Councils, the council is currently engaged in establishing international harmonization excipient monographs for the more popular pharmaceutical excipients. A list of important and popular pharmaceutical excipients is given in Table 1. 

Source Data supplied by the International Pharmaceutical Excipient Council. 

International Pharmaceutical Excipients Council (IPEC). GMPs for Excipients (1995). Martinez, Rivera, E. FDA perspective on BPC GMPs. Pharm Eng (May/June 1994). Pharm. Inspection Convention (PIC). GMP Guidelines for APIs Manufacturers (July 1997). 

International Pharmaceutical Excipients Council. Good Manufacturing Practices for Bulk Phamaceutical Excipients www.ipec.org (rev. 2001). 

International Pharmaceuticals Excipients Council. Good Manufacturing Practices Audit Guideline for Bulk Pharmaceutical Excipients. (1997). 

International Pharmaceutical Excipients Council—Americas. What are pharmaceutical excipients . Available at http //www.ipecamericas.0rg/public/faqs.html questi0nl. Accessed September 9, 2007. 

International Pharmaceutical Excipients Council of the Americas (IPEC-Americas)... 

E-mail Address info ipecamericas.org Web Address www.ipecamericas.org International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) is a trade organization that promotes standardized approval criteria for drug inert ingredients, or excipients, among different nations. The organization also works to promote safe and useful excipients in the U.S. 

Good Manufacturing Practice Guide for Bulk pharmaceutical Excipients. International Pharmaceutical Excipient Council. Arlington, VA, 1995. 

Progress in drug delivery systems and new proteins/ peptides being developed for parenteral administration has created a need to expand the list of excipients that can be safely used. An informational chapter included in the USP 24, presents a scientifically based approach for safety assessment of new pharmaceutical excipi-ents.f This chapter is based on the excipient safety evaluation guidelines prepared by The Safety Committee of the International Pharmaceutical Excipient Council, with appropriate reaction. Table 14 summarizes the approach in developing a new excipient. 

Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients The International Pharmaceutical Excipients Council Arlington, VA, 2000. 

The International Pharmaceutical Excipients Council Guideline for Distribution of Bulk Pharmaceutical Excipients, 2000. 

International Pharmaceutical Excipients Council Europe. IPEC Europe News Jan 2003. 

Progress on the comparison of monographs for excipients published in The International Pharmacopoeia and those adopted in the Pharmacopoeial Discussion Group (PDG) process was noted. The Committee was pleased to note the offer of technical assistance by the International Pharmaceutical Excipients Council (IPEC). 

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