Who Should Attend?
The interactive workshops will explore the USP excipient GMP requirements and will review the various methods of ensuring conformance, emphasizing site audit. The USP excipient GMPs were developed from the IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients which serves as the basis for this workshop.

Both workshops will emphasize excipient GMP auditing techniques. They are intended for pharmaceutical and chemical company auditors whose duties require them to asses the practices followed in excipient manufacturing. Distributors of food, drug and dietary supplement ingredients and products who wish to asses the practices of companies they represent should also attend.

Half-day workshop attendees will learn how to focus an excipient audit on the most significant compliance issues typically found at such manufacturing sites. Those from excipient user companies, for example, will benefit by learning how to conduct more effective audits. Makers of excipients for use in pharmaceuticals will gain an understanding of where their resources may need to be refocused to prove GMP compliance and distributors will be better equipped to assess whether their suppliers' practices are adequate to offer the material as excipient grade.

The full-day workshop will begin with a detailed discussion of the half-day workshop content and include added details on common site deficiencies and requirements to achieve a minimal level of excipient GMP compliance. At the completion of the full-day workshop, attendees will be able to focus on the compliance issues that are important to the manufacture of excipients as opposed to those of API or dosage form manufacture. Participants also will gain an understanding of risk-based excipient auditing and thereby should be able to assess an excipient GMP quality system to ascertain if it can achieve a satisfactory level of compliance for one to consider a chemical as an excipient ingredient.

Workshop materials will be based on IPEC GMP Guide standards as set forth in USP28/NF23 chapter <1078>. Irwin Silverstein, Ph.D., IPEA COO, will present the workshops.