Contributors
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Irwin B. Silverstein, Ph.D.
Lead Trainer and Consultant
IPEC-Americas Excipient Learning Lab
Irwin was the ISP Corporate QA Director until 2000 and has worked since 1991 with IPEC to develop appropriate GMP requirements for excipients. He was VP and COO of International Pharmaceutical Excipients Auditing and achieved ANSI accreditation in 2010 for the IPEA Excipient GMP Certification program. Dr. Silverstein is a member of the NSF committee that wrote the American National Standard (ANSI) for Excipient GMP. Irwin now is a consultant to IPEC and conducts audits for USP under their Verification Program. Irwin provides consulting services on Quality and Regulatory compliance with an emphasis on pharmaceutical excipients. -
Jeffrey Brambora
Principal GMP Consultant
BlackTower Quality Group, Switzerland
After studying organic and biochemistry in the United States, Jeffrey Brambora started his pharmaceutical career with Eli Lilly as a manufacturing chemist, later holding multiple roles in QA, including Consultant Supplier Quality Auditor. After moving to Europe, he worked as a Senior GMP Auditor for Novartis Pharma in Basel, Switzerland. Jeffrey has more than two decades of international experience working for multi-national pharmaceutical companies in quality management systems, supply chain quality management, and manufacturing quality. He has audited a wide range of industries and is certified by the American Society for Quality as both a Quality Auditor (CQA) and a Pharmaceutical GMP Professional (CPGP). Jeffrey has co-authored multiple international GMP guidelines and standards, including several IPEC guidelines, NSF/IPEC/ANSI 363 (the United States national standard for excipient GMP), the EXCiPACT® GMP Annex, and the latest version of the IPEC‑PQG GMP Guide. In his consulting work today, Jeffrey concentrates primarily on auditing, lead auditor training, and quality management system optimization.