Quality Culture, Regulatory Focus News Letter, Your Partner

DEVELOPMENT OF A QUALITY CULTURE

Hi, Greetings from FWQRC……

Today’s topic is about the development of a Quality Culture and the supporting role of international standard development

Quality Culture is a term being discussed with increasing regulatory among quality professionals as well as more widely outside of the quality profession, as organisations and governments consider continuous challenges including productivity, competitive strategy and reputation protection.Within a quality culture, everyone is involved in the ongoing pursuit of excellence

Pharmaceutical culture of quality

Each worker or team is both a supplier & customer within their organisation and takes responsibility for the quality of their output. In this setting, there is no need to check the final products as an incremental review has occurred on an ongoing basis at each stage

Conversely, the absence of a quality culture is likely to be characterized by an absence of individual or team responsibility and the need for costly & time consuming inspection and test regimes which add little value

Conclusion: Given the more elusive nature of culture compared to other facts of organisation life, it is not unreasonable for individuals to look for external sources of guidance. Assistance may be required to understand current culture, determine that culture which might best address requirements and to help define & deliver actions to support the quality culture journey.

Write to fwqrcservices@gmail.com to understand your organisations current culture, determine that culture and deliver actions to support the quality culture

Agriculture, Food, Regulatory Focus News Letter, Your Partner

FDA, USDA and EPA announce joint platform to streamline information about agricultural biotechnology products

Hi,Welcome to FWQRC Regulatory Focus News Letter…

Today, in recognition of January 2020 as National Biotechnology Month, the U.S. Food and Drug Administration, the Department of Agriculture and the Environmental Protection Agency launched a Unified Website for Biotechnology Regulation. The website streamlines information about the three regulatory agencies charged with overseeing agriculture biotechnology products and is part of President Donald J. Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.

“This is a time of unprecedented scientific innovation. Agricultural biotechnology promises to bring dynamic new products to the marketplace,” said FDA Commissioner Stephen Hahn, M.D. “At the FDA, we are committed to fostering flexible, risk-based approaches in this field while upholding our mission of protecting and promoting both human and animal health and animal well-being, for example by reducing their susceptibility to diseases like novel influenzas and resistance to zoonotic or foreign animal diseases. Our approach balances our internationally respected, science-based review standards with our ongoing risk-based regulatory approaches to ensure the safety of our food supply.”

The Unified Website for Biotechnology Regulation describes the federal review process for certain biotechnology products and allows users to submit questions to the three agencies. The goals of this website are to provide enhanced customer service to innovators and developers, while ensuring Americans continue to enjoy the safest and most affordable food supply in the world and can learn more about the safe use of biotechnology innovations.

In October 2018, the FDA announced its Plant and Animal Biotechnology Innovation Action Plan, which focuses on the agency’s risk-based regulatory approach. This approach will help secure confidence in the reliability and performance of plant and animal-based innovative products for consumers and America’s global trading partners. Making sure these products are safe is critical to maintaining consumer and commercial confidence in them and will help them to realize their full potential benefits for human and animal health.

The FDA uses a flexible, risk-based approach to the oversight of plant- and animal- derived products of biotechnology, focusing on safety and, where applicable, effectiveness. The agency’s approach includes, when appropriate, updating and clarifying science-based policies to support innovation and ensure that our regulatory processes are efficient, predictable, and proportionate to risk.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Your Partner

New year greetings

We wish that all your wishes are fulfilled this year.

Stay connected with FWQRC…

Food, Healthcare Institutions, Life Sciences, Regulatory Focus News Letter

Investigation of Listeria monocytogenes

Welcome to FWQRC Regulatory focus news LetterHere we are going to review on the Outbreak Investigation of Listeria monocytogenes Linked to Hard-Boiled Eggs, December 2019FDA, CDC, and state and local partners are currently investigating a multistate outbreak of Listeria monocytogenes infections linked to foods that contain hard-boiled eggs. On December 20, 2019, Almark Foods recalled and suspended production of hard-boiled and peeled eggs in pails due to the potential for contamination with Listeria monocytogenes. These hard-boiledand peeled eggs were sold in pails under the following names: Rainbow Select Hard-cooked Eggs, Rainbow Select Hard-cooked Eggs in Vinegar, Nic’s Salad Hard-boiled Eggs, Almark Hard-cooked Eggs, and Sutherland Select Hard-cooked Eggs. A full list of recalled products is included below.RecommendationFood processors, restaurants, and retailers should not sell or serve any of the recalled hard-boiled and peeled eggs in pails from Almark Foods. These products were not sold directly to consumers.Additionally, FDA recommends that food processors, restaurants and retailers who have received Almark Foods bulk, fresh hard-boiled eggs, use extra vigilance in cleaning and sanitizing any surfaces that may have come in contact with these products, to reduce the risk of cross-contamination.Background:As of December 17, 2019, a total of seven people infected with the outbreak strain of Listeria monocytogenes have been reported from five states. In interviews, ill people answered questions about the foods they ate and other exposures in the month before they became ill. Of the five people for whom information was available, four reported eating products containing eggs. Three of these people reported eating hard-boiled eggs in deli salads purchased from grocery stores and in salads eaten at restaurants. Illnesses started on dates ranging from April 10, 2017 to November 12, 2019.Additionally, based on whole-genome sequencing, the Listeria monocytogenes found in environmental samples collected at the firm’s processing facility during an FDA inspection conducted in February 2019 is a genetic match to the outbreak strain. FDA is conducting additional inspections and sampling. Almark Foods has been cooperating with the ongoing investigation and announced a voluntary recall of hard-boiled and peeled eggs in pails on December 20, 2019.This outbreak strain was found during environmental sampling in 2017 of one other food facility. That facility is not currently handling food and ceased operation in 2018.Thank you for viewing FWQRC blogs….