On November 14th, at FLAVORCON 2018 in Atlantic City, NJ, Erin Crowley will present, "Fit for Purpose: Matrix Verification Studies for Microbiological Methods and Rapid Pathogen Detection."
Method to the Madness
During the validation process, food diagnostic solutions manufacturers attempt to demonstrate that their microbiological test kit or instrument is capable of analyzing a vast array of representative products. Therefore, microbiological methods are routinely validated against several matrices, such as meat, poultry, powdered milk, leafy greens, etc. Since flavors and raw ingredients are often complex, proprietary compounds, these commodities are not routinely included in the validation process. Consequently, when certain diagnostic tests are utilized on non-validated matrices, they can produce false positive or false negative results. Attendees at Erin's presentation will learn how to determine if a particular rapid pathogen detection method is fit-for-purpose for their product(s) and how partnering with a qualified laboratory to perform the verification studies will help them comply with Food Safety Modernization Act (FSMA) regulations and assure the data generated from their pathogen testing program is accurate. (more…)
On September 6, the FDA submitted for comment a Draft Guidance entitled, “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials: Guidance for Industry.”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 milligrams. The World Health Organization (WHO) has established a definition of probiotics as, “live microorganisms which, when consumed in adequate amounts, confer a health benefit on the host.” The FDA defines a live microbial as, “a single-celled prokaryotic or eukaryotic microorganism that is intended to be viable at the point of ingestion.” Therefore, it is problematic to indicate live microbials by metric weight because it does not provide any indication of therapeutic efficacy or strength of the probiotic ingredient(s).The International Probiotics Association (IPA) attempted to reconcile this issue in January 2016 by submitting a Citizen Petition asking the FDA to amend the existing regulation to require listing the quantitative number of probiotics in dietary supplements on product labels as Colony Forming Units (CFU) instead of milligrams. The petition cited CFUs as the best available metric for indicating the number of viable cells. The IPA pointed out that the FDA has previously allowed CFUs as a measurement metric for New Dietary Ingredient (NDI) notifications as well as applications for Generally Regarded as Safe (GRAS) designation. (more…)
Q Laboratories’ Chief Scientific Officer Erin Crowley will present a webinar on October 26, at 10:00am EDT entitled, “Outcomes and Future Work of the AOAC ISPAM Harmonization Project.” The International Association for Food Protection (IAFP), Methods Validation & Verification Interest Group within the Applied Laboratory Methods Professional Development Group (PDG) organized the webinar.According to the IAFP website, “(t)he global marketplace has put significant pressure on Method Developers to validate their new technologies via several different certification organizations, all of which have their own unique components to consider in a study design, there continues to be a wealth of support across the industry to harmonize across several reference methods, validation guidelines and procedures.This session will present the evolution of Harmonized validation guidelines through the ISPAM initiatives, where we are currently aligned and where we need to go from here. Perspectives on what potential activities can be achieved through ISPAM collaborations through global interlaboratory studies and verifications for a more globally representative set of food commodities will also be discussed.”
ISPAM Strives for Harmonized Methods
AOAC INTERNATIONAL formed the International Stakeholder Panel on Alternative Methods (ISPAM) in 2011 to develop harmonized, internationally accepted standard validation guidelines for alternative (rapid) chemical and microbiological methods by leveraging global networks of experts to reach consensus on an analytical validation protocol. The goal is to achieve optimal efficiency and avoid duplication of efforts to meet regulatory and product safety testing requirements. The Panel includes more than 60 stakeholders from industry, government, academia, and international organizations.Erin Crowley, currently the Chair of ISPAM, will be joined by DeAnn Benesh, Global Regulatory Affairs Manager, 3M Food Safety in presenting the webinar.Click here to register for the webinar. http://bit.ly/2OMgwle
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 unformulated material that may subsequently be formulated with excipients to produce a dosage form. A drug "product" is the formulated mixture of the drug substance and excipients comprising the final marketed dosage form.For a drug substance, stability testing determines the "re-test period," the timeframe during which the drug substance is expected to remain within its specification, and therefore can be used in the manufacture of a given drug product. After the established re-test period has elapsed, a drug substance can only be used if additional specification testing is performed, the material passes inspection, and the substance is distributed soon after meeting acceptance criteria.For a drug product, stability testing determines the shelf-life of the product by establishing the duration for which the product is safe to use and retains therapeutic value according to the level of the active ingredient(s). (more…)
Q Laboratories' Director of Quality, Cathleen Owen, will serve as a Workshop Leader at the upcoming Personal Care Products Council (PCPC) 2018 GMP Workshop on July 11th in Los Angeles. The workshop will consist of multiple breakout sessions addressing current topics in Good Manufacturing Practices (GMP). Sessions will include round-table discussions and Case Study presentations. In addition to Cathleen, who currently serves as Chair of the PCPC Quality Assurance Committee, other Workshop Leaders include experts from the Food and Drug Administration, Academia, and representatives from Procter and Gamble, Mary Kay, Edgewell, Revlon and others.
PCPC Workshop Topics
Topics discussed will include: strategies for successful FDA inspections, improving the efficiency of FDA inspections, best practices for responding to 483 observations, FDA expectations regarding electronic records and data integrity, audit trails and data integrity, handling Out of Specification (OOS) test results and documenting OOS investigations, and key aspects that impact imported products and how to avoid common errors related to the entry submission process.The Workshop will be held at the Omni Los Angeles Hotel At California Plaza. For more information or to register for the event Click here.