Irwin Silverstein
Dr. Silverstein is a consultant specializing in quality assurance and regulatory compliance for pharmaceutical excipient ingredients. He also has experience in areas of quality assurance for API, medical device and drug products.
Dr. Silverstein was responsible for the development and implementation of the
IPEA Excipient GMP Conformance Certification Program. IPEA was accredited by the American National Standards Institute (ANSI) as a Conformity Assessment Body and recognized by the U.S. FDA.
He was formerly the Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. He has worked with the International Pharmaceutical Excipients Council (IPEC) since 1991 developing guidance documents for excipient GMP compliance and has represented IPEC at various conferences, to educate the public on these documents, and at the Food & Drug Administration. In addition to working as a consultant to the industry, he is the Chief Operating Officer of International Pharmaceutical Excipients Auditing Inc (IPEA) and a technical consultant to IPEC.
As part of his continuing efforts to improve the conformance of excipient ingredients to appropriate GMP requirements, Irwin has developed a 3-day course titled “Excipient GMPs” for the Center for Professional Advancement. He has also prepared GMP training courses for site management and hourly employees such as operators, maintenance and laboratory technicians. He was a co-developer and lecturer for the 3-day IPEA Excipient GMP Audit workshop. Dr. Silverstein also helped in the design of the American Society for Quality Certified Pharmaceutical GMP Professional (CPGP) and in the preparation of questions for the certification examination.
His recent consulting has broadened to include pharmaceutical firms where he assesses conformance to site requirements. He has audited excipient manufacturers to perform a gap analysis with respect to excipient GMP compliance and has provided detailed guidance as to how to improve their conformance to excipient GMP requirements. As an experienced GMP auditor, with American Society for Quality (ASQ) Certified Quality Auditor (CQA) status as well as ISO 9000 Certified Lead Auditor training, he has developed the IPEA auditor training program and has trained their auditors.