EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
Validación de limpieza CIP
Presentado por Bernardo Clavijo. Para dar cumplimiento a los requisitos legales y normativos vigentes, es importante realizar la validación de las medidas de control de la inocuidad, entre las cuales está la limpieza y desinfección de las superficies de contacto. ¿Qué significa esto para su...
What are the Requirements for a Successful DMF Submission for an Active API?
EAS independent consultant, Radhika Rajagopalan answers your questions on DMF submissions in Tablets and Capsules magazine. Under the Generic Drug User Fees Act (GDUFA), the FDA applies a holistic, life-cycle approach to the evaluation of active pharmaceutical ingredients (APIs), featuring...
Find the Right Mix: Flavors and Textures and the Discerning Consumer
By Joe Yun Ph.D. Reprinted with permission from Dairy Foods Magazine. You may have heard the statement, “milk is nature’s perfect food.” Nutritionally speaking, that is true. But is the quality of dairy products we consume always perfect? Have you noticed that when you lift a freshly baked pizza...
Pharmaceutical GMPs, Quality Control, and Data: A Deeper Look at FDA’s FY 2020 FDA Observations
By Amy Scanlin Reprinted with permission from FDLI UpdateGood Manufacturing Practices—those minimum requirements for methods, facilities, and controls used in manufacturing, processing, and packing of drug products.1 Though clearly articulated by FDA, a review of FY 2020 pharmaceutical inspection...
Developing and Implementing a Supplier Qualification Program for Dietary Supplements
Presented by EAS Independent Consultant, Aisha Siddiqui. The FDA regulations dictated in 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, require the establishment of component (Dietary Ingredient)...
CBD and Hemp Manufacturing and Safety
A Three-Part Webinar Series October 20, 27 & November 4, 2021, each at 1pm ETEAS Consulting Group, leaders in FDA, USDA and state regulatory issues, is hosting a three-part series on hemp-derived CBD regulations. From a higher-level look at where federal regulations stand today to a deeper...
Drug and Device Corner July 2021
The FDA has planned a public webinar titled Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency. Please follow the link to register for this webinar scheduled for 25 August 2021. Recently published in the Federal Register, FDA has issued their final...
USDA News: USDA Announces $500 Million for Expanded Meat & Poultry Processing Capacity
USDA has announced a $500 million for expanded meat and poultry processing capacity as part of efforts to increase competition and level the playing field for family farmers and ranchers. This is one of several key steps that USDA intends to take that will increase competition in agricultural...
Did You Know? EFSA No Longer Considers Titanium Dioxide E 171 a Safe Food Additive
The European Food Safety Authority (EFSA) no longer considers titanium dioxide E 171 a safe food additive after safety assessments prompted by a request by the European Commission in March 2020. Using Nanotechnology as part of its assessment, the EFSA determined that titanium dioxide E 171...
Labeling Risk Management – Five Step Plan
By Ronald J. Levine Food labels are under attack. Every day new lawsuits are filed, often as class actions, as well as through regulatory actions. Legal actions concerning words such as “natural,” or “healthy” are all too common. THE FIVE STAGES OF GRIEF While some of the large food manufacturers...
CBP and FSVP: Has Your Product Undergone Substantial Transformation?
Are your FDA-regulated food products made with ingredients sourced from outside the U.S.? If so, and if they are further processed, your food product may have resulted in a new or different product that differs substantially from its original state before processing. In FDA’s and CBP’s (U.S....
FSNS Announcement
We are excited to announce that Certified Group has signed an agreement to merge with Food Safety Net Services (FSNS), a leading provider of laboratory testing services for customers in the food & beverage end-markets. As a result, the newly combined entity will grow to an impressive ~1,580...
Tara Couch Discusses FDA Enforcement of Dietary Supplements in RAPS Regulatory Focus
The pandemic has resulted in an increase in the number of misbranded dietary supplements. As a result, FDA is using updated, alternative, and remote enforcement tools to ensure compliance. Tara Couch, Senior Director for dietary supplement and tobacco services covers what you need to know in a...
Cleaning Validation – Your GMPs Depend on It
Presented by Joe McGuinness, EAS Independent Consultant. For FDA to require that equipment be clean prior to use is nothing new, with the main rationale to prevent contamination or adulteration of drug products. Per FDA’s current Good Manufacturing Practices (cGMPs), the protection against cross...
Did You Know? FDA Amends Standard of Identity for Yogurt
On June 11, 2021, FDA published in the Federal Register a final rule amending the standard of identity for yogurt, 21 CFR 131.200. The final rule, more than a decade in coming, (proposed rule was published in 2009) has been a priority under FDA’s Nutrition Innovation Strategy. Under the final...
Supply Agreements-Defining Acceptable Quality Limits for Packaging
By James Goldman CPP, EAS Independent Consultant “It’s the packaging supplier’s fault!” Package quality disputes between suppliers and customers often start with someone in the filling plant stating “these packages aren’t as good as the ones we ran last week” without any data to support their...
Meet Our Cosmetics Team
Did you know the EAS Cosmetics Team includes former FDA and high-level industry? From colors to claims, from formulation to safety, our experts can answer any manufacturing and regulatory challenge you may have. Stay in compliance with the FD&C Act. Trust EAS!Here are just a few of our EAS...
Drug and Device Corner June 2021
The FDA has published the OMUFA Arrears list on their OTC Monograph User Fee Program webpage, with information as of 11 June 2021. In addition to establishments being named on the arrears list, drugs manufactured at facilities that have not satisfied their OMUFA FY2021 obligation are deemed...
June Drug Registration / Listing
As you are probably aware, per 21 CFR 207.57 FDA drug establishment registrants must review and, if necessary, update listing information each June and December. This includes all drug listings, including bulk products. EAS provides support with facility registrations and product listings and we...
Adverse Event Reporting for OTC Drug Products
By EAS Senior Advisor for OTC Drugs and Labeling Susan Crane The Food and Drug Administration monitors the safety of drug products marketed in the United and requires the pharmaceutical industry to document and, as applicable, report adverse events experienced by consumers when using their...