Sancilio & Company, Inc. (SCI) has established 21 CFR Part 210/211 Compliance Auditing Services for drug manufacturers importing materials, supplies, products and excipients from Asia. The new service is based in Shanghai.

According to Fred D. Sancilio, Ph.D., chief executive officer and chief scientist of SCI, “Recent quality issues discovered in a variety of products from Asia are urging U.S. companies to increase their vigilance in quality while importing when importing materials from overseas. American pharmaceutical, nutritional and food manufacturers typically have responded by physically sending auditors from the U.S. to Asia. Our new facility obviates this approach, as our Chinese auditors—fully fluent in English and Mandarin and trained in U.S. cGMP procedures—are already on the ground.”

Dr. Sancilio added, “Offering hands-on compliance auditing experience, our China-based auditing experts provide extremely fast turnaround, at a small fraction of the present costs to U.S. companies. Direct benefits of our new 21 CFR Part 210/211 Compliance Audit Service are enhanced assurance of compliance, integrity of product, cost effective redundant review of the quality of supply, elimination of long delays at U.S. ports of entry, and drop-in audits at any time.”