pharmaphorum

MARCH 22, 2022

In this article, Ben Hargreaves asks whether there is particular potential for the technologies to revolutionise staff training and reduce costs in pharma manufacturing. The importance of manufacturing. the streamlining of pharma manufacturing in the 21st century. Taking manufacturing to the next level.

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XTalks

SEPTEMBER 12, 2022

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.

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STAT News

JANUARY 19, 2023

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.

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The Pharma Data

MARCH 29, 2022

an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Food and Drug Administration (FDA) announced today that Bravo Packing, Inc., Related Information.

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XTalks

AUGUST 7, 2023

coli outbreak between 1992 and 1993 that claimed the lives of four children who had eaten contaminated burgers from the fast-food chain Jack in the Box. This heart-wrenching event prompted an increased focus on fast-food safety regulations. But the documentary argued that more regulatory work is still needed. It becomes a commodity.”

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STAT News

JANUARY 10, 2023

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.

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XTalks

APRIL 17, 2023

While food safety regulations and advances in technology have greatly reduced the incidence of such events, some of the worst food safety incidents continue to occur. The causes of these events varied, from contaminated food and water to zoonotic diseases and poor hygiene practices. coli O157:H7 bacteria.

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NY Times

APRIL 30, 2021

The step was taken after Health Canada learned that an active ingredient was made in a Baltimore plant with contamination problems.

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pharmaphorum

MAY 5, 2022

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.

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Contamination Regulation Scientist Manufacturing 52

XTalks

AUGUST 25, 2023

In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). These certifications are often sought by food manufacturers to assure consumers about the safety of their products for those with food allergies, intolerances and special dietary requirements.

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XTalks

APRIL 11, 2024

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.

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XTalks

MARCH 10, 2022

Traditional food safety testing methods used in manufacturing facilities are inconsistent, time consuming and often require trained technicians. So, if a food manufacturer identifies a positive Salmonella result in its facilities, the impact of the positive result differs greatly depending on whether it is pathogenic or not.

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Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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XTalks

SEPTEMBER 17, 2020

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.

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NY Times

MAY 10, 2022

The report sheds new light on executives’ worries about deficiencies in the company’s quality control systems at its troubled Baltimore plant; no contaminated doses were ever released to the public.

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Contamination Vaccination Vaccine Manufacturing 95

Roots Analysis

OCTOBER 24, 2023

Owing to the advancement in clinical pharmacology and oncology domain, and the rising demand for targeted therapeutics and precision medicines, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become one of the key areas of interest to researchers and drug manufacturers across the globe.

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XTalks

AUGUST 4, 2023

The recalls affect cookies, broccoli-cheddar soup and falafel, raising concerns over possible contamination with foreign objects like insects or rocks. ” The Trader Joe’s recall appears to be a voluntary move , a common practice amongst companies facing contaminated food products. .”

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FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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pharmaphorum

JUNE 8, 2022

Driving a Holistic Approach to Assurance of Product Sterility through Aseptic Manufacturing following QRM Principles. Join us to discuss and address the Guidance and Regulation including the EU GMP Annex 1, environmental control delving into the contamination control strategy, Pharma moving forward 4.0

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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pharmaphorum

MARCH 19, 2021

Since the third quarter of last year DeepVerge’s scientists have been working to transform an AI-based water contamination detection system into a unit that tests for the presence of the coronavirus. A femtogram is 0.000000000000000001 kilograms.

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The Pharma Data

JANUARY 6, 2021

Discover five good manufacturing practices for water monitoring and sanitization for pharmaceutical use. The control of water quality throughout the manufacturing lifecycle of a product, including storage and distribution, is a major focus for compliance regulators. Add bookmark. Download Your Copy.

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Compliance Manufacturing Regulation Contamination 52

XTalks

NOVEMBER 22, 2022

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.

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FDA Law Blog

MAY 23, 2023

Specifically, field staff are advised to pay close attention to situations where allergen cross-contact may occur because of poor current good manufacturing practices (cGMPs), inadequate preventive controls, or inadequate controls under the juice or seafood HACCP regulations.

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The Pharma Data

JANUARY 13, 2021

Avoid risking the quality of water in manufacturing practice, subsequent product process delays and compliance issues with this handy guidebook. The control of water quality throughout the manufacturing lifecycle of a product, including storage and distribution, is a major focus for compliance regulators. Add bookmark.

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Compliance Manufacturing Regulation Contamination 52

XTalks

AUGUST 12, 2020

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.

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XTalks

AUGUST 10, 2023

This variety may increase Trader Joe’s recall risk compared to stores sourcing from large-scale manufacturers. coli outbreak between 1992 and 1993 that claimed the lives of four children who had eaten contaminated burgers from the fast-food chain Jack in the Box.

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Drug Discovery World

OCTOBER 5, 2022

In essence, manufacturing complex drugs with controlled drug delivery or release profile enhances the therapy that is based on the patient’s individual data. . For the therapy side, organ manufacturing for implantation (human spare parts), drug formulation (personalised medicine) becomes based on personalised data.

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pharmaphorum

JULY 21, 2022

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. Upgrading facilities. Implementing Pharmaceutical Quality systems.

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XTalks

FEBRUARY 21, 2022

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Each BioNTainer is a clean room equipped with state-of-the-art manufacturing solutions.

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XTalks

DECEMBER 20, 2021

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.

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FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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XTalks

OCTOBER 21, 2022

The review explains how local health departments can prioritize retail food regulations if unprecedented public health emergencies occur in the future. A contamination at a retail establishment has the potential to greatly impact public health. Related: What Does the FDA Registration Renewal Process Entail for Food Manufacturers?

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Pharmaceutical Technology

DECEMBER 20, 2022

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.

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XTalks

APRIL 12, 2022

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.,

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The Pharma Data

MAY 3, 2021

Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . . Reviewing nitrosamine contamination. Continuous professional development. Upcoming in Regulatory Focus What’s coming in May?

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XTalks

JULY 12, 2023

mm resolution sensor to identify contaminants; however, it’s inadequate to detect pin bones and other sub-mm diameter bones. If bones are detected, manufacturers have two options: either reject the products containing bones or put in place additional control procedures. For detecting such minute bones, a 0.05

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