Experts

Excipients

Contact Center Expert: Irwin Silverstein, Ph.D., President, IBS Consulting, http://ibsconsulting.home.att.net, and COO, IPEA, www.ipeainc.com

Dr. Silverstein has worked as an independent consultant for the past five years, specializing in excipient auditing and compliance. His clients include several major pharmaceutical companies, which he has helped assess compliance, develop training and auditor training workshops, and evaluate quality programs and failure investigation reports. He previously worked as corporate director of Quality Assurance for ISP. He has a Ph.D. in chemistry from New York University, and is an American Society for Quality Certified Quality Auditor (CQA) as well as a Certified Lead Auditor for ISO 9000. He has taught a course on Pharmaceutical Quality Assurance and Control for the Center for Professional Advancement, and has also presented seminars on GMP and ISO compliance to FDA, AAPS, ISPE, International Institute of Research, Interphex and other organizations. Among several publications, he wrote the chapter on Quality Assurance”for the Kirk-Othmer Encyclopedia of Chemical Technology., Fourth edition, Vol 20, pp. 721-738.

---

Informing customers of a process change
I am making a process change in the manufacture of an excipient. Do I have to inform my pharmaceutical customers?
Category: Excipients

Selling a chemical as USP grade
I produce a chemical that, when tested, meets the requirements in the USP for the excipient grade. Can I sell this chemical as USP grade?
Category: Excipients