Compliance

A New Emphasis on Safety Levels & Other Highlights from the HPCUS 2019 Annual Meeting

By Eric Foxman, Senior Scientist, HCPUS and Secretary, AAHP   The Homeopathic Pharmacopeia Convention of the United States (HCPUS) held its annual meeting in April 2019. The HCPUS—the group of homeopathic professionals responsible for publishing the Homeopathic Pharmacopoeia of the United States, our industry’s recognized compendium—came together to identify key readm more…

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Summit Photos: Experience the Excitement

The AAHP community is still abuzz from all the excitement, networking, and learning that took place at last month’s Quality and Safety Summit in Baltimore! Between the opening reception and following day of sessions, we hosted more than 100 people from five countries across the globe. With a keynote session readm more…

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Educational Webinar Resources Available

Missed an education opportunity? Need materials for your mandated employee training? You have a second chance! AAHP webinars can help fulfill your required mandatory staff training requirements. Homeopathic manufacturers and marketers have found AAHP to be an excellent third-party source for this training.   All DVD’s include an MP4 recording readm more…

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A First Look at AAHP Summit Speakers

We are thrilled to offer a first look at the speakers and sessions for our upcoming Summit on Challenges and Solutions in Quality & Safety of Homeopathic Drug Products! This unique one-day workshop is designed to help you manufacture safe products while complying within FDA and FTC guidelines. Some of readm more…

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How to Work with FDA on Voluntary Recalls

By Mary Borneman, Sr. Director, Communications & Public Affairs, Standard Homeopathic Company/Hyland’s, Inc.   In April 2019, U.S. Food & Drug Administration (FDA) published a draft guidance* Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C (“the Draft Guidance”). The purpose of this new guidance is “to clarify readm more…

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Safe Drugs, Happy Consumers: Sterility Assurance Programs

By Kristina Skowronek, Director of Quality and Regulatory Compliance, Boiron USA USP GENERAL CHAPTERS, GENERAL INFORMATION, 〈1211〉 STERILIZATION AND STERILITY ASSURANCE OF COMPENDIAL ARTICLES If we were to manufacture a drug product that is purported to be sterile but cannot be terminally sterilized without ingredient or package degradation, a sterility readm more…

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Initiation of Voluntary Recalls: Draft Guidance for Industry and FDA Staff

By Mark Land, AAHP President   Product recalls are an important tool that manufacturers and the U.S. Food and Drug Administration (FDA) use to minimize exposure to potentially harmful or ineffective products.1 Drug product recalls are voluntary — that is to say, FDA does not have legal authority to recall readm more…

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Overview: Membership Meeting 2019

The membership of AAHP came together on March 8 for the association’s semiannual Membership Meeting. Taking place during Natural Products Expo West in Anaheim, Calif., AAHP members convened to hear updates on projects and initiatives, network, and elect new leadership before hitting the tradeshow floor. Three-Pronged Strategic Approach for 2019 readm more…

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Reduce Risk with Product Substantiation

Susan J. Hewling   When bringing products to market, it is essential to build a platform that allows all information generated to be available for future use,” advised Susan J. Hewlings, PhD, RD, during a preview for her workshop this June at the AAHP Summit in Baltimore. Guest speaker at readm more…

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Why Pharmacovigilance Matters

By Mark Land, AAHP President Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.1 Serious adverse events for non-prescription drugs including homeopathic drug products have been required to be reported to FDA since 2007.2  Today readm more…

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