The American Association of Homeopathic Pharmacists (AAHP) recently hosted a webinar on 2017 improvements to the Homeopathic Pharmacopeia of the United States (HPUS). Highlighting new manufacturing best practices in the HPUS—which more than tripled to 175 from 40 in the prior version—the webinar underscored how this extensive resource can help manufacturers produce safe and effective homeopathic drug products.
Recognized by the United States Federal Food Drug and Cosmetic Act, the HPUS is the official compendium of homeopathic active ingredients and manufacturing guidelines. AAHP’s webinar covered two major areas in the document: good manufacturing practices (GMPs) and drug stability guidelines. Eric Foxman, senior scientist with the Homeopathic Pharmacopoeia Convention of the United States (HCPUS), the organization that publishes and updates the HPUS, facilitated the session.
Foxman first covered manufacturing best practices. The result of five years of deliberations, the expansions are designed to be consistent with modern pharmaceutical manufacturing and drug GMP. Additions include new facilities controls around temperature and humidity in manufacturing plants as well as documentation guidelines for supplier and vendor management. The HPUS also saw expanded rules for the sourcing, handling, purity testing and storage of both botanical and chemical raw materials.
“The product of about 2,225 hours of work between the more than 30 members of the HCPUS, the new HPUS covers more than ever before,” said Foxman. “It is a testament to the homeopathic industry’s dedication to continual improvement.”
New drug stability guidelines in the HPUS aim to ensure that drug products will remain in their intended form over the entire period of their use. Foxman explained that manufacturers are now required to identify and document the individuals who are responsible for assessing stability. The expanded stability section also includes guidelines for material usage, risk analysis, expiration dating and retesting of product stability.
“The importance of the HPUS in guiding homeopathic manufacturing and marketing organizations cannot be overstated,” said Mark Land, AAHP president. “And that’s why AAHP continues our educational programming around this and other topics that help our industry set a high bar in manufacturing excellence and product safety and effectiveness.”
The webinar is the first of AAHP’s 2017 Compliance Thru Education series, which aims to help AAHP members and nonmembers alike keep abreast of the latest in regulatory compliance and manufacturing trends affecting the homeopathic industry. Other webinars will cover key issues such as over-the-counter (OTC) labeling and product recall procedures.
For more information, visit www.aahp.info.