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Third Party Auditors
By Jonathan Priest As in any business, knowing current regulatory standards and your company’s status when compared to those standards is a key to remaining...
FDA Is Paying Attention to Retained Samples—Manufacturers Should Too
By Mary Beth Watkins The retention of reserve samples and their annual inspection records are a routine part of most cGMP inspections by FDA. In...
Radio Frequency Identification (RFID) in the Pharmaceutical Supply Chain
By Joerg Zimmer Summary: RFID is a technology that uses radio waves to automatically identify objects. RFID technology can deliver many benefits, from tracking work...
Prudent Use of Special Warnings on Labels?
By Eric L. Foxman, R.Ph. The HPCUS Council on Pharmacy (CoP) has discussed the appropriateness of warning statements for a number of homeopathic substances. The...
Customs-Trade Partnership Against Terrorism
By Joerg Zimmer and Mark Land Introduction: In direct response to 9/11, the US Customs Service, now U.S. Customs and Border Protection (CBP) challenged the...
Assisting the Patient Who Uses Homeopathic Medicines
By Andy Bormeth, Originally appeared in U.S. Pharmacist, April 2002 The strong growth in natural products has led to an increasing number of homeopathic medicine...
FDA’s Electronic Filing System for Facility and Drug Registrations
By Jonathan Priest On October 23, 2008 the FDA released its draft guidance on the new electronic submission system for drugs and establishment registrations. This...