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The presenter discussed what a pharmaceutical company should do when their excipient supplier won’t allow an on-site audit. For various reasons, excipient manufacturers are not always able to accommodate site audits by all their customers. However, the FDA encourages - and may soon expect - that pharmaceutical companies include site audits as a part of their excipient supplier qualification process. Currently site audits of excipient manufacturers are encouraged by the Falsified Medicines Directive, which has recently been adopted as guidance by PIC/s. So, what is a pharmaceutical company to do?
This webinar introduced several alternatives to 2nd party audits that should satisfy current and emerging regulations in this area.
1. Identify alternatives to excipient manufacturer audit by the customer
2. Determine Quality Management System requirements for use of third-party audit and certification as part of a supplier qualification program
3. Identify appropriate controls for use of a food additive, dietary ingredient, or cosmetic GMP compliant material in lieu of an excipient
Dr. Irwin B. Silverstein. Irwin is a consultant to IPEC and the excipient industry 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.
For 17 years he was Corporate Director of Quality Assurance for International Specialty Products (ISP) with responsibility for their excipient, API, and medical device products. Since 1991, he has worked with the International Pharmaceutical Excipients Council (IPEC) developing guidelines for excipient GMP compliance and has represented IPEC at various conferences and at the Food & Drug Administration.