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ICH Q7 API GMP Q & A

In April, the FDA released a Guidance Document, entitled, “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs) – Questions and Answers – Guidance for Industry.” The document is intended to “provide guidance regarding good manufacturing practice (GMP) for the manufacturing of APIs under an appropriate system for managing quality…and help ensure that APIs

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COO Letter

Within the last few weeks we have begun moving our laboratory operations into our brand new 30,000 ft. facility. This marks another chapter in the remarkable story of Q Laboratories. Those of you who have been clients for a long time have been part of the evolution of the company from a small regional laboratory

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ASTA Spices and Seasonings

For producers of spices and seasonings, preventing microbial contamination can pose a complex problem. The American Spice Trade Association (ASTA) makes available multiple resources on their website to help firms keep these low-moisture commodities free from pathogens and other bacteria. Three beneficial publications are, the “Good Manufacturing Practice (GMP) Guide for Spices (2015),” the “HACCP

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Safe Food For Canadians

Effective on January 15, 2019, the Safe Food for Canadians (SFC) Act and Regulations are now the primary food law in Canada. The Canadian Parliament passed the SFC Act in 2012, and the Canadian Food Inspection Agency (CFIA) published the final version of the regulations on June 18, 2018, setting the stage for January 2019

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Produce Safety Guidance

Data gathered by the Centers for Disease Control and Prevention (CDC) between 1998 and 2008 indicated that produce (raw vegetables, leafy greens, fruit) caused up to 46% of all foodborne illnesses reported in the U. S. each year. The FDA attempted to address this problem by creating the Produce Safety Rule (PSR) as part of

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FDA-FSMA Recall authority

When President Obama signed the Food Safety Modernization Act (FSMA) into law in 2011, it gave the FDA, for the first time, the power to order a recall of a food product determined to potentially present a danger to the public. Prior to FSMA, the FDA could only recommend that a manufacturer perform a voluntary

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Probiotics article CFUs

On September 6, the FDA submitted for comment a Draft Guidance entitled, “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials: Guidance for Industry.” The document addresses how to list the quantity of probiotic ingredients on dietary supplement product labels. Current FDA regulations require listing dietary ingredients, including probiotics, by metric weight such as

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COO Letter

I came across two articles recently that reminded me how complex the science of microbiology remains, and how this complexity continues to present challenges for the food safety industry. The first article was oddly enough entitled, “E. coli is good for you?” and reported on a University of Colorado at Boulder study, appearing in the

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COO Letter

Within the last few weeks we have begun moving our laboratory operations into our brand new 30,000 ft. facility. This marks another chapter in the remarkable story of Q Laboratories. Those of you who have been clients for a long time have been part of the evolution of the company from a small regional laboratory

Read More »

FDA Forces Recall

The Food Safety Modernization Act (FSMA) enacted in 2011 empowered the FDA to order mandatory recalls of food products determined to be potentially harmful to humans or pets due to adulteration such as pathogen contamination, or presence of allergens not indicated on the label. Before implementation of FSMA, the FDA could strongly suggest that a

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