Consider the FDA and CDER in Guiding Your SOP

Three letter acronyms are annoying. Four doesn’t make it any easier.

Many people hear The Center for Drug Evaluation and Research (CDER) and Food and Drug Administration (FDA) and it has the same appeal and reaction as human gas in a packed elevator on the long ride to the “Top of the Rock” in New York City. The agency’s role is to protect the people in USA from people intentionally and unintentionally making products that are not safe for human consumption.

So, I encourage an open mind about them and not throw the baby out with the bath water when considering your Standard Operating Procedures (SOP).

As so many people are identifying and implementing the BEST principles and practices (below), the next question is what to measure and how to measure and making real progress. The current operations are state of the art facilities focused on BEST, but also looking to improve constantly.

Figure 1. BEST Principles and Practices

BEST Principles and Practices

The Center for Drug Evaluation and Research (CDER) and Food and Drug Administration (FDA) have placed a document for draft review in Botanical Drug Development Guidance for Industry.

It is a detailed draft, but the one that so many people are currently striving for is articulated well in its detail, as well as guidance on how to achieve this in section B (page 12) about Chemistry, Manufacturing, and Controls (CMC). In many respects it discusses specific criteria which I have seen so many companies striving to achieve but trying to write themselves. It encompasses the idea “you can’t manage what you can’t measure.”

Does it include everything you might be concerned about in a state regulation? No, but it will give you a chance to adapt to what you are writing yourself. It includes growing plants within repeatable guidelines as well as any additives that can be used, like pesticides. It includes the same concerns I hear about moisture and molds.

It is worth reading and deciding which parts are applicable to your operation, and I would be interested in your thoughts about it.

Hope you extract the best from your day.

John A. MacKay, Ph.D.

John A. MacKay earned a B.A. in Chemistry from St. Lawrence University (SLU), and a Ph.D. from the University of Vermont (UVM), in Inorganic Chemistry. After positions teaching at Davidson College, Lyndon State College and University of Vermont (UVM), John joined Waters Corporation in 1983. In 1990 John joined Otsuka Electronics as Director of Strategic Development, and then joined Analytical Technology Incorporated, to aid in building a multi-technology company. In 1994, he rejoined Waters after the management buyout from Millipore.

John retired from Waters in March 2017. He founded Synergistic Technologies Associates, LLC works with botanical companies to help maximize their total operations based on Six Sigma principles and practices. In January 2019 he joined New Bridge Global Ventures as the Chief Technology Officer to expand the unique extraction and analytical tools the company will use across its vertical platform.

His career has included many roles in innovative product development and marketing. John is widely recognized as a scientific expert in extraction in the botanical space; he is bringing the synergy from what were disparate technologies together to optimize workflow as well as providing consulting and education services through Genus, NewBridge Global Venture company.

With the expertise and desire to spread the science throughout the industry, John has taken on roles as contributing journalist and science editor for Terpenes and Testing Magazine and was the editor of the early issues of Extraction Magazine and now is contributing journalist and scientific advisor. Synergistic Technologies Associates is focused on the continuing education and source of examining new technologies and practices in the hemp market. He has also been appointed the Educator Assistant Professor on the Volunteer Pathway, Department of Pharmacology at the Robert Larner, MD College of Medicines.

John can be reached at:
[M]+1 774-462-8363
[E] [email protected] or
[E] [email protected]

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