Compliance is More than a Monograph; Other Essential Guidelines Within the HPUS

An Interview with Eric L. Foxman, Pharm. (Ret.)

Beyond monographing more than 1,300 substances, the Homeopathic Pharmacopeia of the United States (HPUS) offers other vital information specific to procuring, producing, and packaging homeopathic products. In May 2017, AAHP presented a webinar on two important guidelines added/updated to the HPUS at that time. These guidelines on GMPs and stability testing are as important today as then, which is why AAHP is taking this opportunity to refresh and remind readers about these valuable homeopathic-specific resources.

NetworkNews: In a nutshell, what did you present in that webinar that continues to be highly relevant today?

Eric L. Foxman: At the time of the webinar, the Homeopathic Pharmacopeia Convention of the United States (HPCUS) had just posted two guideline documents to the HPUS. Those documents and the guidance information contained in them are essential for every homeopathic company. Whether a company manufactures or just markets homeopathic drug products, that information in the HPUS also has a bearing on every product’s compliance status.

NN: What were those two documents?

ELF: The first was a major revision of the HPUS Homeopathic Good Manufacturing Practices Guidelines (accessible by subscription). At first glance, it obviously became much longer. But the changes were more than just additional verbiage. A closer examination reveals the previous version had covered about 40 important considerations; the revised version addresses more than 175 points that manufacturers and marketers need to be aware of and all of which impact procurement, production, and packaging of all homeopathic products. Without awareness of these guidelines, products can fall far short of compliance with overall requirements — even if the company thinks its homeopathic active ingredient(s) meets specifications in the respective monograph(s). It is important to bear in mind that monographs do not exist in isolation but are only the most product-specific part of the HPUS. The guidelines encompass a part of the compliance “terrain” with which products must conform.

NN: And the other document?

ELF: The other new HPUS guideline at the time was the Homeopathic Drug Stability Guidelines (accessible by subscription). It addresses issues concerning stability testing and retest periods; these are subjects that also directly impact every homeopathic product marketed in the United States.

NN: Can you give some examples of the manner in which stability issues are addressed in that guideline document?

ELF: First, the HPUS makes clear that homeopathic products do not get “a pass” when it comes to addressing stability. At the same time, the guidelines note it is not possible to test that certain characteristics of all but the first few attenuations. However, other characteristics, including container/ closure integrity, can certainly be monitored over time; changes in them may well be indicative of changes in the more subtle characteristics which are not measurable.

The guidelines make distinctions regarding stability periods of starting materials (which can be tested, and retested, over time for conformance with all specifications), low attenuations (some of which can be tested over time for conformance, possibly, with a more set of the initial specifications), higher attenuations and finished products (all characteristics of both are unlikely to be testable over time). For all categories, storage conditions are, perhaps, the most important factor to take into consideration. Retest periods — when analytically possible — or examination are essential components of any stability program.

Throughout the guideline, suggested retest periods are stated, but those must be accepted as just that: “suggested.” The HPUS is unable to provide “hard and fast” time intervals as conditions and circumstances will vary from one company and facility to the next. Further, it is incumbent upon companies purchasing starting materials and/ or intermediates to perform audits to ensure their suppliers are providing purchasers with materials that conform to HPUS guidelines. This is especially essential when materials have not been produced from the raw materials immediately preceding shipment.

AAHP previously presented a webinar on Emerging Regulatory Issues, which was a high-level overview of stability considerations. The PowerPoint file from this webinar is available from the AAHP office as a helpful reference document. For those wishing more detailed information, the AAHP’s archive recording of a two-part webinar on Stability Studies for Homeopathic Products is also available from the AAHP office. (This video is accompanied by more than a dozen key CFR and ICH documents on the topic.) For information on ordering either of these, contact the AAHP office.

NN: You have presented or co-presented more than a dozen webinars for AAHP, the majority of which have provided insights into the contents of the HPUS. How long have you been involved with the Homeopathic Pharmacopeia Convention of the United States?

ELF: I am what one might call a charter member of the HPCUS. Looking back, I realize that I have been involved with this Convention for 45 years — since its establishment in 1980. For many years, I was the chair of the Pharmacopeia Revision Committee. I am now in my 18th year on the HPCUS Board of Trustees and for almost as long I have served as the Chair of the Council on Pharmacy. In these capacities, I am active in the ongoing revision and updating of the contents of the HPUS. I also serve on the Monograph Review Committee, and continue, after almost 35 years, on the Standards and Controls Committee. I guess that’s why I have felt the necessity to continually educate the homeopathic industry on the value of and resources within the HPUS.