Compliance

4 Simple Ways to Keep Your Homeopathic Manufacturing Process Safe and Effective

February 2, 2021

Each day AAHP works to promote excellence in the practice of homeopathic manufacturing. While achieving true excellence is a lofty goal, it begins with a few simple principles you can start to implement today.

We’ve reviewed recent Warning Letters from the U.S. FDA—which highlight some of the most common missteps and shortcomings—and have put together these four basic ground rules that can help any homeopathic manufacturer or marketer strive toward excellence.

The Anatomy of a Compliant Homeopathic Label

May 20, 2020

By Eric L. Foxman, R.Ph., AAHP Secretary | Before examining the details of a compliant homeopathic drug product label, it is important to consider labeling in relation to the FDA Draft Enforcement Guidance.

Is the Homeopathic Industry Underinvesting in Quality Systems?

May 20, 2020

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.

Homeopathy Mentioned Twice in FDA 2021 Budget Is Telling of Issues to Come

March 18, 2020

By Mark Land, AAHP President | In February, the White House released the President’s Fiscal Year 2021 Budget. Correspondingly, each agency publishes a detailed budget justification…

In Times of Public Health Crisis, Vulnerable Consumers Look to Us for Sound Advice

March 18, 2020

By Mark Land, AAHP President | I have experienced many infectious disease crises thus far in my lifetime and each one was characterized by fear and uncertainty…

3 Homeopathic Compliance Hot Spots to Watch

February 13, 2020

All drug products, homeopathic and allopathic alike, must be safe and effective. That means they have to be manufactured correctly, containing only the ingredients and potencies they claim to have. In short, all drugs must comply with Current Good Manufacturing Practice (CGMP). It is not only FDA’s responsibility to ensure these medications fulfill the CGMP requirements of safety, identity, strength, quality, and purity—it’s the industry’s responsibility, too.

Dilution Process Validation Is Complex and Data Driven

September 16, 2021

There are more than 1,300 substances currently approved for inclusion within the Homeopathic Pharmacopoeia of the United States (HPUS). Based on discussions with homeopathic manufacturers, many companies work with 300 and 500 different substances. Because each manufacturer works with a different list of substances, most of the 1,300 substances are in commercial production. That’s a…

New FDA Report on the State of Pharmaceutical Quality Fiscal Year 2020

August 18, 2021

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Homeopathy’s Path Ahead: 5 Ways We’re Moving the Needle Together

June 7, 2021

  Homeopathy’s path forward is a collective effort between manufacturers, scientists, homeopathic practitioners, and regulators. Stemming from AAHP’s first Summit in 2019 with FDA keynote speaker Francis Godwin, the industry identified five key areas where quality control compliances are murky. Resolving these issues to avoid individual interpretations will reduce the risk of FDA warning letters…

The Importance of AAHP’s 2021 Summit

June 7, 2021

Implementing HPUS Guidelines for FDA Compliance, Part 2     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…

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