By George Bernstein, PhD
If you have participated in AAHP Summits over the past couple of years, you are no doubt aware that FDA has raised the bar regarding compliance by homeopathic manufacturers with 21 CFR Part 211 (GMPs). I have been present in the audit room during FDA inspections of homeopathic manufacturers in the U.S. and internationally and have noted that FDA is becoming more knowledgeable of homeopathic manufacturing. Observations made during inspections now include supplier qualification, ID and bioburden testing of incoming homeopathic substances, process validation (attenuation, impregnation, content uniformity for tablets), and stability programs for both homeopathic substances and finished products.
With this, homeopathic manufacturers face challenges, namely, how to meet those expectations and respond to the auditor’s questions when there are no prescribed answers. For example, how would you explain how you confirmed the identity of 1M Arsenicum that you’ve purchased from a supplier? Or how would you justify that the surrogate used to validate a mixing process meets the FDA’s expectation of “performed under actual conditions of use?”
In my years as a consultant, deviation investigations have been an area of interest for me and a particularly weak area for most allopathic and homeopathic manufacturers. Most of you (I hope) understand that root cause analysis is an essential component of these investigations. I thought that it would be interesting to see if there might be a root cause for the number of FDA Warning Letters issued to homeopathic manufacturers over the past few years.
To me, an inexperienced quality assurance department is the most likely root cause, while changes in FDA expectations and enforcement actions are contributing factors. An experienced quality assurance department should be proactive in addressing the shifting FDA inspection “minefield” relatively unscathed.
So, what corrective and preventive actions (CAPAs) should homeopathic manufacturers make in order to be better prepared? Some have suggested that it’s GMP (Get More Paper), and others have suggested it’s GMP (Get More People). However I’d argue that the best investment a homeopathic manufacturer can make is to hire an experienced quality assurance manager. Yes, it’s true that this may be a difficult and expensive undertaking, but the costs associated with FDA compliance actions can be significantly more, including consultant costs, loss of revenue, and the potential closure of your business.
Author: George Bernstein, PhD is President of MAI Consulting, Inc. (www.ConsultMAI.com). His expertise ranges from GMP compliance, facility design, construction, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many clients with audit preparation, remediation activities, and communications with FDA. And for 30 years, his family (including pets) have used homeopathic medicines. Dr. Bernstein served as the Quality Track Leader for AAHP’s 2019 Summit and can be reached at 919-434-3005.