What is the ELAP Certification and why is it important? We are happy to announce that Q Laboratories is now approved by the New York State Department of Health’s Environmental Laboratory Approval Program (ELAP). New York ELAP approval is required in New York as part of the Protection Against Legionella regulation which was passed in July, 2016. This
Bactericidal Considerations to the FDA Briefing Document As you may or may not have heard, the FDA has released a Briefing Document in March of 2020 that proposes an alternative organism panel from the Tentative Final Monograph (TFM) for consumer and healthcare antiseptics. Amongst growing interest from our clients on this topic, we have authored
Raw Material Testing for Material Identity, Purity and Quality Are you in need of a raw materials testing partner? Are you in the process of qualifying new material suppliers for your supply chain, and need raw materials testing? Raw Material Testing & Analysis Registered with the FDA for pharmaceutical testing (Reg. #1527260), cGMP/GLP Compliant and
Q Labs Provides A Wide Range Of Efficacy Testing Services To Support Label Claims For Your Products Sanitizers and disinfectant products make label claims that indicate the effectiveness of their products. Hand Sanitizers, disinfectant wipes, and cleaning products all do it. In fact, if you look at the label of several popular household disinfectants, it
In January, the FDA released the second revision of the Draft Guidance, “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” The Agency initially submitted the Draft Guidance in 2014 and followed up with Revision One in December 2018. Currently, GMPs for drug
After a series of negative reports regarding the cannabidiol (CBD) industry, recent developments have given stakeholders a ray of hope. A December 2019 article on this BLOG discussed the recent Food and Drug Administration (FDA) activities intended to reiterate that CBD is not an approved ingredient for use in foods and dietary supplements,
Title II, Section 202 of the Food Safety Modernization Act (FSMA), signed into law in January 2011, instructed the Food and Drug Administration (FDA) to establish a program for the testing of food by accredited laboratories. FSMA stipulated that accredited labs must possess “a demonstrated capability to conduct one or more sampling and analytical testing
Recent activity by the Food and Drug Administration (FDA) has taken some wind out of the sails of the burgeoning cannabidiol (CBD) industry. In a Consumer Update released in late November, the FDA reminded constituents that CBD is not approved for use in food or dietary supplements for humans or animals. Citing a paucity of
Q Laboratories Director of Sales for the Food Industry, Will Melnyczenko is the Special Guest and Featured Speaker at the Institute of Food Technologists (IFT) Florida Section Holiday Dinner on December 3rd in Orlando. The topic of the presentation will be, “Challenge Testing vs Shelf Life Testing – Navigating the Differences.” Will has nearly 20
The Food and Drug Administration has extended the comment period regarding the New Era of Smarter Food Safety initiative. Originally targeted for November 20th, the new “comment by” date is now December 20th. Smarter Food Safety Intended to build upon the Food Safety Modernization Act (FSMA), the Smarter Food Safety initiative emphasizes utilizing modern technology
In September, at the AOAC International Annual Meeting in Denver, Q Laboratories’ Chief Scientific Officer Erin Crowley was announced as President-elect of the AOAC International Board of Directors. She will complete one year as President-elect and then serve as President of the BOD for 12 months beginning with the 2020 AOAC Annual Meeting in Orlando. Erin is Chair of the AOAC
You pour your heart and soul into your products. You spend eight hours a day (who am I kidding, at least eight) assuring items are safe and of the highest quality. Except for your family, you spend more time caring for and nurturing your products than anything else in your life. How can you be
According to data compiled by the Centers for Disease Control and Prevention (CDC), approximately 1 in 31 (3.2%) of U.S. hospital patients contract a healthcare-associated infection (HAI). This amounts to approximately 2 million nosocomial infections per year in the US, resulting in 90,000 deaths and incurring a cost of $28- $45 billion to hospitals, Medicare/Medicaid,
Due to concern over, “the continuing outbreaks of foodborne illness associated with the consumption of raw and lightly-cooked sprouts,” the FDA recently released a Draft Guidance entitled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting Guidance for Industry.” After reviewing 50 outbreaks of foodborne illness associated with sprouts between 1996-2018, resulting
Stakeholders familiar with the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) may have noted the Agency’s efforts to minimize the financial and time-consumption burdens placed on smaller regulated establishments who may not possess the vast resources of larger firms. Companies designated as “Small Businesses” are granted more time to reach compliance with
In 2004, responding to an increase in foodborne illnesses caused by allergens, the United States Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA). Implemented in 2006, FALCPA established clear guidelines for labeling foods regarding the presence of allergens, providing consumers with more straightforward and accessible information to protect their families and themselves.
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
High Quality Testing Of Drug Substances & Drug Products Stability testing is utilized to determine if the quality of a drug substance or drug product is altered over time by various environmental factors, such as light, temperature, and humidity. A drug “substance,” often referred to as an Active Pharmaceutical Ingredient (API), is defined as the
Q Laboratories is the first United States-based laboratory to include Norovirus and Hepatitis A testing in food, water and environmental samples listed on their ISO 17025 Scope of Accredited Methods. An A2LA Assessor was onsite at Q Laboratories on June 15 to evaluate the rapid, qualitative methods and facilities used to screen for the viruses.
Q Laboratories served as the expert laboratory on two studies resulting in AOAC approval of methods recently named Methods of the Year by the AOAC International Official Methods Board. The studies, commissioned by Bruker Corporation, demonstrated proficiency of AOAC Official Method 2017.09 Confirmation and Identification of Salmonella species, Cronobacter species, and Other Gram-Negative Organisms Bruker
On Thursday, May 17th, Cincinnati Mayor John Cranley and Hamilton County Commissioner Denise Driehaus were on hand to help cut the ribbon on Q Laboratories’ new 30,000 sq.ft., $10 Million laboratory building located on Knob Hill in East Price Hill on the Westside of Cincinnati. Q Laboratories’ COO David Goins has been with Q Laboratories
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