November 2018 | VOLUME # XVIII| ISSUE # 1B
  Letter from the COO
The leaves have fallen, baseball season has transitioned into football season, and students are settled in back at school, all sure signs that Autumn has arrived. Here at Q Laboratories, we consider every season back-to-school season because we recognize the need always to continue learning.
Elemental Guidance
As the one-year anniversary of the implementation of new elemental impurities requirements for brand and generic drug products approaches on January 1, the FDA has released a Guidance Document entitled, “Elemental Impurities in Drug Products: Guidance for Industry.”
New Chapter
The United States Pharmacopeia (USP) has proposed a new chapter to address one of the most prevalent microbiological threats in the pharmaceutical and healthcare industries. USP proposed Chapter <60> “Microbiological Examination of Nonsterile Products—Tests for Burkholderia cepacia Complex ," provides, for the first-time, compendial methods for detecting these troublesome microorganisms.  
New Hire
Jason Brown has been named Manager of the Analytical Chemistry Department at Q Laboratories. Jason will be responsible for the day-to-day operation of the Chemistry Laboratory including sample flow-through, analyst training and compliance. He will also work to optimize the work flow of the laboratory to increase efficiency and minimize turn-around times for testing.
Jason has a B.S. in Chemistry from George Fox University in Newberg, Oregon. He previously worked as QC Laboratory Supervisor at Fujimi Corporation in Tualatin, OR.
Updated Protocol
In September, the SIDI TM Workgroup released an updated version (Version 3.0) of the Standardized Information on Dietary Ingredients (SIDI TM ) Protocol. A group comprised of the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA), and their member companies produced this most recent version. | | (513) 471-1300
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