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As with any pharmaceutical manufacturing, challenges can be many, and processes are highly regulated. This heightens the risk of cross contamination, requiring effective containment solutions, especially when handling highly potent powders. Please check your email to download the Webinar.
The US Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) declared Salmonella an adulterant in raw breaded stuffed chicken products when contamination levels exceed one colony-forming unit (CFU) per gram. This approach emphasizes stringent testing and preventive measures at earlier stages of the supply chain.
MIT engineers have designed a food sensor , made from an array of silk microneedles, that can pierce through the plastic packaging of foods to sample for bacterial contamination and spoilage. Two kinds of specialized “bioinks” react to the bacterial presence and certain pH levels, which respectively detect contamination and spoilage.
Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety. With operator intervention being a primary source of contamination, finding ways to reduce human contact has been an ongoing challenge and goal in aseptic filling.
Since metal contamination is a common issue in food production, resulting in expensive recalls and lawsuits, the FDA has implemented metal detection standards to ensure the same principles are followed for all companies. So why is metal contamination such a common reason for launching voluntary recalls?
On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Health Canada is accepting comments on the Minister of Health’s proposal to amend the FDR and the Medical Devices Regulations until October 28, 2021.
It does, however, regulate toxins in other consumer products including arsenic, lead and cadmium, and the agency previously declared them dangerous to human health, particularly to babies and children. Currently, the US Food and Drug Administration does not set limits on heavy metals in most baby foods.
A probe has identified 'human errorâ at the Spanish contract development and manufacturing organization, Rovi, as the reason for the presence of metal contaminants in Moderna COVID-19 vaccine doses, leading to Japanese authorities withdrawing 1.6 million doses of the shot in August.
Salmonella Outbreak from Poultry — The US A widespread Salmonella outbreak linked to contaminated poultry affected thousands across multiple states this year. This persistent strain of Salmonella , also known as REPJFX01, not only led to significant illnesses but also prompted a massive recall and stricter regulations on poultry processing.
Quality Assurance is a team effort : From manufacturers to regulators, QA professionals, and beyond, everyone plays a critical role in ensuring the quality and safety of generic drugs. So, what can we learn from the importance of Quality Assurance in generic drugs?
The Environmental Protection Agency for the first time on Tuesday proposed enforceable regulations for “forever chemicals,” also called PFAS, in Americans’ drinking water. The six PFAS are the first new contaminants to be regulated under the Safe Drinking Water Act’s 1996 amendments.
UMD-led study warns cascading effects of salts require coordinated management and regulation to avoid contaminating natural resources Credit: Sujay Kaushal When winter storms threaten to make travel dangerous, people often turn to salt, spreading it liberally over highways, streets and sidewalks to melt snow and ice.
Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. FDA’s Regulatory Framework on Lead in Food Lead contamination in food can arise from various environmental sources, including past usage of lead in paint, gasoline and plumbing materials.
Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems.
SUMMARY: Pharma companies, like J&J, have received criticism for engaging in illegal activities, such as providing kickbacks and bribes, knowingly shipping adulterated or contaminated drugs to pharmacies, and marketing drugs for unapproved uses. Johnson & Johnson has paid $2.7 billion in penalties. Ethical leadership!
In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses. Continue to STAT+ to read the full story…
In this week’s episode of the Xtalks Food Podcast, Sydney discusses the Baby Food Safety Act of 2021 which aims to help the FDA regulate heavy metal contamination in baby food. Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? Is there arsenic in your baby food? Read the full articles here: .
New regulations are often reflective of the supply chain, food safety and consumer trends. Here are some of the top food industry regulations food and beverage companies should watch out for in 2022. Regulating Heavy Metals in Baby Food. Cannabinoid Regulations.
The topic of sanitation regulation is also covered in ‘ Catalysing Citywide Sanitation For All Through Regulating Service Providers ‘ by IWA’s Regulation for Citywide Inclusive Sanitation initiative’s advisory and taskforce members – Yvonne Magawa (ESAWAS), Diego Polania (CRA), and Gustavo Saltiel (World Bank).
Despite explicit cooking instructions on labels, the persistence of Salmonella -related illnesses underscores the necessity for strict regulations. Approximately one in every 25 chicken packages at grocery stores is contaminated with Salmonella. Subscribe to the Xtalks Food Podcast to never miss a new episode.
When freeze drying sterile pharmaceuticals, mass spectrometry helps manufacturers protect valuable batches from silicone oil contamination – a possible risk of the lyophilisation process. Preventing silicone oil contamination Silicone oil is a common component of lyophilisation systems.
Sprouts can carry a risk of foodborne illness if they are contaminated, and unlike other fresh produce, the warm, moist conditions required to grow sprouts are ideal for the rapid growth of bacteria, including Salmonella , Listeria , and E. No confirmed illnesses related to Fortune Food’s products have been reported to the FDA.
Pesticides continue to linger on our food, even on crops where their use has been banned, pointing to systemic issues in food safety regulations. The EWG also provides a “Clean Fifteen” list , highlighting produce with the least pesticide contamination. Reducing and Avoiding Pesticides It’s not all doom and gloom.
The requirements come from two specific FSMA regulations: the Preventive Controls for Human Food (PC Human Food ) and Produce Safety. And under three FSMA regulations, suppliers may also use third-party audits to verify their activities. Related: Is the FDA Doing Enough to Regulate Added Chemicals in Foods?
Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. By Sophia R.
Free Whitepaper Future-proofing parenteral packaging against nitrosamines During the last five years, pharmaceutical industry regulators have been forced to look closely at the contamination risk of nitrosamines. This whitepaper discusses the issue of nitrosamine contamination since 2018 and the response from regulators and industry.
Thomson International, a company based out of Bakersfield, California, has recalled red, yellow, white and sweet yellow onions shipped from May 1, 2020 until now due to potential Salmonella contamination. of Bakersfield, California, USA, or any products made with these onions. More about Salmonella.
In another study evaluating the microbial load of a plant-based meats, the researchers concluded the products they studied were susceptible to post-processing contamination. FDA Regulation. The storage and handling of these products should mimic that of raw meats,” the authors wrote. Dietary and nutritional factors.
Assuring end-patient safety through holistic contamination control. With advances in rapid microbiological methods, revised industry regulation, enhanced knowledge of innovative therapies, and novel testing methods, this industry is ever expanding. Sponsored by: Associates of Cape Cod, Bioscience International and Ecolab.
These tiny particles, primarily from environmental contamination, can infiltrate the food supply. Microplastics and nanoplastics primarily contaminate food through environmental exposure where crops and livestock are raised. Macroplastics and microplastics are growing concerns within the food industry.
In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). Xtalks spoke to Betsy Craig, CEO and founder of MenuTrinfo, to find out how the company certifies products and where government regulations fall short. We go to the facility.
Both the Minute Maid and Coca-Cola beverages are set to expire in 2022, which means consumers might still have products that contain the unspecified contaminants. coli , listeria or salmonella contamination in raw produce and meat, this is not the first beverage-related recall this year. While recalls tend to address E.
Breweries, for example, buy barley and malt from different parts of the world depending on the weather, to avoid the risk of mold contaminating their grain. Europe produces 70 percent of the world’s olive oils, with strong regulations governing its production and supply. But it’s not enough. Traceability.
for an Improved, Efficient and Contaminant-Free Cleanroom. Key Reasons to attend: Learn how to maximise the latest cleanroom technologies to modernise your contamination control strategy. Increase your cleanroom availability & accessibility through streamlined approaches to contamination control. Advances in Pharma 4.0
Last week, the US Food and Drug Administration (FDA) issued its final rule on Requirements for Additional Traceability Records for Certain Foods , which includes food traceability protocols for a variety of food products susceptible to contamination. Related: Here’s How the FDA is Making it Easier to Trace Foods.
Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? The US Food and Drug Administration (FDA) estimates that nearly 48 million people are sickened by food contaminated with harmful germs each year, with produce being the culprit in many cases.
the owner of Kinder Chocolate, Nutella and Tic Tacs, among other brands, is voluntarily recalling its Kinder Happy Moments Chocolate Assortment and Kinder Mix Chocolate Treats basket, due to possible Salmonella contamination. The problem, however, doesn’t lie in regulations, but in a lack of enforcement by member states. Ferrero U.S.A.,
Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. In this episode of the Xtalks Food Podcast, Sydney talks about how lead contamination in food can arise and what the FDA is doing to monitor lead levels.
The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. On top of this, some regulations have changed, plunging more facilities into the possibility of not complying. Implementing Pharmaceutical Quality systems.
Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. And even once the facility is fit for purpose, specialised staff are required to maintain compliance with strict regulations. Meeting strict standards.
Regulations and guidelines for nanopharmaceuticals are still relatively in their infancy, including for cleaning processes and the prevention of cross-contamination.
As a staple spice in many kitchens, the discovery of elevated lead levels in cinnamon products has prompted a closer look at food safety practices and regulations. Why Cinnamon is Prone to Higher Lead Levels Cinnamon can become contaminated with lead through various pathways. One primary source is environmental contamination.
In order to manufacture GMP regulated cell therapies, it is necessary to assess each manufacturing step at regular intervals. Contamination is a key concern when it comes to manufacturing cell therapy products. The major steps involved in cell therapy manufacturing have been briefly outlined below.
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