Regulatory and cost benefits
In addition, GMP requirements for API manufacture are more explicit because of FDA requirements and guidelines from the International
Conference on Harmonization. Official GMP requirements do not exist for excipients but standards are expressed in industry
produced guidelines, whose application can vary greatly because of the range of processing involved. For example, the application
of GMP standards for a salt producer that mines, purifies, and packages salt for use as an excipient would probably be very
different from that of a synthetic excipient manufacturer.
There is one final significant difference between auditing excipient and API manufacturers. Because excipient manufacturers
have numerous customers as compared with API manufacturers, it is feasible for excipient manufacturers to reduce audit assessment
costs for their customers (and to themselves through a reduction in customer visits) by allowing the sharing of audit reports.
It was for these reasons that IPEC–Americas formed its excipient GMP auditing subsidiary, International Pharmaceutical Excipients
Auditing, Inc. (IPEA) in 2001 to assist excipient producers and their pharmaceutical customers. For example, the report of
an IPEA third party audit requested by an excipient manufacturer can, if the company wishes, be shared with its potential
customers. When this is publicized, it has served to reduce the number of new audit requests producers have received for up
to two years after the IPEA audit.
Of note: An IPEC–China organization is being formed to join IPEC–Americas, IPEC–Europe and IPEC–Japan.Nevin Cheng of Shanghai Coating
Technology, Ltd. will act as general manager for ongoing organizational efforts.
Irwin Silverstein, PhD, is vice-president of International Pharmaceutical Excipients Auditing Inc., the GMP auditing subsidiary of the International
Pharmaceutical Excipients Council of the Americas. For more information, he can be contacted at email@example.com