Implementing HPUS Guidelines for FDA Compliance, Part 2

 

By Mark Land, AAHP President

 

AAHP’s newsletter editor asked me to write an article explaining the importance of the upcoming June 15 Summit: Implementing HPUS Guidelines for FDA Compliance, Part 2. This Summit is the second installment of a compliance program being developed by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS) and presented by AAHP. This program aims to develop guidance for manufacturers and FDA related to the challenges of working with micro-dilutions of active ingredients.

The HPCUS proposes to include five new guidelines in the areas of starting materials receipt and inspection, dilution process validations in liquid and solid phases, uniformity of dosage units, and finished product testing. During this year’s Summit, we will examine nearly-completed work on starting material receipt and inspection and a concept paper on process validation study design for liquid Hahnemannian dilutions.

Dr. William Shevin, President of HPCUS, will remark on the history of the Homeopathic Pharmacopoeia of the United States and why it is important to participate in the activities of the HPCUS. Dr. Nelly Bibak will introduce our presenters and update us on the progress across the five topic areas.

Why should you participate in this year’s Summit? In short, you need to know and contribute to what is being discussed because these guidelines will become requirements for your organization in the near future. Implementation of the validation programs and testing plans are foundational to any drug manufacturing process. Changes in these areas require a great deal of time and resources. You can’t afford to be surprised by these requirements. Participation is the best way to inform and prepare yourself and your company for the future.

During the September 2020 Summit we heard from Dr. Grobin on concepts and challenges in the area of homeopathic active ingredients. Now Dr. Grobin will present conclusions in this area and guidelines for manufacturers when receiving homeopathic active ingredients. Specifically important is how do you manage active ingredients that are received in concentrations below the limit of detection.

Also in September we heard from Francis Godwin of FDA. Francis reported on FDA’s compliance observations of homeopathic manufacturing sites. At this Summit we will hear from FDA’s Dr. Richard Lostritto on compliance challenges related to micro dilutions and FDA’s expectations for homeopathic manufacturers in this area.

Isabelle Chanel, an analytical chemist at Boiron’s global headquarters, will present a concept paper on process validation approaches for the manufacture of Hahnemannian liquid dilutions. Her presentation makes recommendations for validation project design, surrogate markers, and risk analysis for substances with known toxicity.

If you haven’t already registered for this event, do so now. There is no better investment of your time on June 15.