Articles

Third Party Auditors

January 24, 2014

As in any business, knowing current regulatory standards and your company’s status when compared to those standards is a key to remaining in compliance with both regulatory expectations and client expectations. One way to accomplish this comparison is to hire a third party auditor with the appropriate experience and knowledge to provide an independent perspective on the challenges homeopathic companies encounter under FDA regulations and client requirements.

FDA Is Paying Attention to Retained Samples—Manufacturers Should Too

January 24, 2014

The retention of reserve samples and their annual inspection records are a routine part of most cGMP inspections by the FDA. In the May 31, 2010 Tan Sheet, the publication reported that the FDA had warned Perrigo in a 483 posted May 28th, for failing to annually inspect retained samples.

Radio Frequency Identification (RFID) in the Pharmaceutical Supply Chain

January 24, 2014

RFID is a technology that uses radio waves to automatically identify objects. RFID technology can deliver many benefits, from tracking work in process to speeding throughput in a warehouse.

Prudent Use of Special Warnings on Labels?

January 24, 2014

The HPCUS Council on Pharmacy (CoP) has discussed the appropriateness of warning statements for a number of homeopathic substances. The discussion only focused on low attenuations of three substances.

Customs-Trade Partnership Against Terrorism

January 24, 2014

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 trade community to partner with CBP to design a new approach to supply chain security focused on protecting the United States against acts of terrorism by improving security while simultaneously…

Assisting the Patient Who Uses Homeopathic Medicines

January 24, 2014

The strong growth in natural products has led to an increasing number of homeopathic medicine departments in pharmacies across the country. Because there is still much controversy and misunderstanding by patients surrounding homeopathic medicine, U.S.Pharmacist asked Andy Bormeth, R.Ph. of the American Association of Homeopathic Pharmacists (AAHP), which represents the homeopathic drug industry and works as a liaison with FDA, state boards of pharmacy and pharmacy organizations, to discuss how pharmacists can best assist patients who use homeopathic medicines, the role homeopathy plays in health care, and to answer some basic questions regarding homeopathy.

FDA’s Electronic Filing System for Facility and Drug Registrations

January 24, 2014

On October 23, 2008 the FDA released its draft guidance on the new electronic submission system for drugs and establishment registrations.

Homeopathic Industry Perspectives — Can More Be Better?

January 24, 2014

Natural products’ consumers now have more choices than ever in the homeopathic medicinal category.

Finished Product Testing

January 24, 2014

Current Good Manufacturing Practices (cGMPs) require manufacturers of homeopathic drug products to establish finished product specifications and to ensure product quality by testing products for conformance to specifications prior to release.

FDA Requirements for Final Product Testing: Current State of Regulation and Implications for the Industry

January 24, 2014

Final Product Testing of drug products has been a fixture in Title 21 of the Code of Federal regulations. Since the outset, this requirement has caused some difficulty for the manufacturers of homeopathic drug products (HDPs) since the final drug concentration in the final homeopathic dosage form often fell below the limits of measurement.

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