February 2019 | VOLUME # XVIII| ISSUE # 2B
Letter from the COO
Time and time again when working with a client to isolate the source of contamination in their products or manufacturing facility, we ultimately determine that water is the source of the problem.
     Although it may seem like a benign agent in the manufacturing and cleaning process, our experience has shown that water is frequently the root of many contamination or product quality problems.  
Compounding Attention
In December 2018, the FDA released a Draft Guidance entitled, “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.”
    According to the document, the FDA intends to promulgate new regulations pertaining to compounding pharmacies that register as “outsourcing facilities” under Section 503B of the FD&C Act.
Supplement Work
On December 12, during a speech at the Food and Drug Law Institute (FDLI) Enforcement, Litigation, and Compliance Conference, FDA Commissioner Scott Gottlieb M.D. announced the formation of the FDA Dietary Supplement Working Group.
Q Laboratories has promoted Benjamin Bastin to the role of Microbiology Research and Development (MRD) Laboratory Supervisor. Ben will be responsible for assigning studies to research teams, working with clients and accreditation bodies to draft and optimize study protocols, and supervising all functions of the MRD Laboratory. Ben holds a Biology degree from Urbana University in Urbana, Ohio. He has been with Q Laboratories since 2013.
Probiotics Best Practices
While not possessing statutory authority, a helpful guide for manufacturers of probiotics products is, “Best Practices Guidelines for Probiotics,” created through a partnership between The Council for Responsible Nutrition (CRN) and the International Probiotics Association (IPA).  
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