By Mark Land, AAHP President
I’ve been pondering this question for some time, ever since preparing for my presentation on FDA enforcement trends during AAHP’s Quality and Safety Summit last June in Baltimore.
As I pored through various FDA databases, the statistics began to tell an interesting story—one that possibly illuminates an important opportunity for our industry to improve.
Did you know that, in the three years between 2015 and 2018, the number of labelers of homeopathic products in the United States almost doubled? And, according to FDA data, there were 160 homeopathic manufacturing sites worldwide making products destined for American consumers at that time.
As of my June 2019 presentation, the FDA had inspected about 140 of those sites, and they were in process to close the gap and visit the other 20. The agency usually does 30 homeopathic site inspections per year, and therefore homeopathic manufactures should expect an inspection every five years.
So, what comes of those inspections? Quality systems are the most cited problem areas. In fact, between 2009 and 2018, 11 of the top 20 citations were in the quality system.
Which leads me back to my question: are we underinvesting in our quality and laboratory systems? This data suggests that the answer could be yes. If we remember our most important goals—to produce high-quality products and to protect and promote consumer health—this underinvestment could spell trouble for our industry.
I suggest that every homeopathic drug manufacturer take a look at quality performance. How is your overall compliance with cGMPs? Do you have well-documented procedures and specifications? What about change control, reprocessing, batch release, annual record review, validation protocols, and reports? If these areas are lacking, get the right people to help. Make sure your quality system is in tiptop shape—not only so you will pass FDA inspection, but to ensure the safety of the consumers who count on you.
Homeopathic Establishments Citations by Sub Part 2009 – 2018