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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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. Continue to STAT+ to read the full story…

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XTalks

SEPTEMBER 12, 2022

Food and beverage companies across the supply chain must always be prepared for new regulatory developments in 2022 as they seek to bring new ingredients and products to market. New regulations are often reflective of the supply chain, food safety and consumer trends. Regulating Heavy Metals in Baby Food.

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Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. So, we set out to solve some of the problems,” she explains.

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The Pharma Data

NOVEMBER 18, 2020

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).

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XTalks

NOVEMBER 2, 2020

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?

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XTalks

AUGUST 21, 2020

Michel Nielen, professor of food safety at Wageningen University & Research, in the Netherlands wanted to create a fundamental change in the world of food monitoring, so he and his team coordinated the FoodSmartphone project which is developing ways to detect food quality and safety using smartphones. But it’s not enough. Traceability.

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XTalks

JUNE 7, 2022

They are caused by bacteria, viruses, parasites or chemical substances entering the body through contaminated food or water. An estimated 420,000 people in the world die every year after eating contaminated food, with children under five years old carrying 40 percent of the foodborne disease burden. How to Get Involved .

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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. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceutical products.

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XTalks

APRIL 19, 2023

Researchers at McMaster University in Canada have developed a rapid Salmonella test for detecting contamination in chicken and other foods, which could help to reduce the cost of food processing and improve food safety. Traditionally, Salmonella detection was done through a series of tests that could take several days to complete.

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The Pharma Data

MAY 3, 2021

Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Other articles examined communication – one on persuasive skills, another on disseminating of regulatory intelligence – and the regulatory response to nitrosamine contamination of drug products. . .

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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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pharmaphorum

NOVEMBER 24, 2022

Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. million to deliver – as well as demanding specialist skills to maintain to industry standards – their widespread development has been slow. Meeting strict standards.

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pharmaphorum

JULY 22, 2022

for an Improved, Efficient and Contaminant-Free Cleanroom. From the new operating practices that keep the product as sterile as possible, to the developments in technology that are enabling this to happen. Key Reasons to attend: Learn how to maximise the latest cleanroom technologies to modernise your contamination control strategy.

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Roots Analysis

JANUARY 27, 2025

In order to manufacture GMP regulated cell therapies, it is necessary to assess each manufacturing step at regular intervals. The development of cell therapy products requires a robust population of cells that can be subjected to genetic alterations, without being damaged in this process.

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XTalks

DECEMBER 1, 2021

Not only can the PD100 ensure produce is safe to eat, but it can also help users develop better fruit and vegetable washing habits over time. Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? It comes equipped with a wireless charging station and lasts for six hours per charge.

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XTalks

NOVEMBER 4, 2022

The ability to rapidly test and detect these pathogens on food and processing equipment allows for immediate intervention and remediation that can reduce widespread contamination that results in loss of product, foodborne illness and subsequent devastating economic impact to the food producers associated with product recalls.”.

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The Pharma Data

OCTOBER 30, 2020

The fifth meeting of the Emergency Committee convened by the WHO Director-General under the International Health Regulations (IHR) (2005) regarding the coronavirus disease (COVID-19) took place on Thursday, 29 October 2020 from 12:30 to 16:05 Geneva time (CEST). Proceedings of the meeting. Diagnostics, therapeutics, and vaccines 10.

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pharmaphorum

MARCH 22, 2022

The efforts underway to strengthen the manufacturing process across the industry have become more important than ever, as the therapies the industry is developing increase in complexity. However, with a number of deals and investments being made in the space, the demand is there to develop more efficient methods of training and manufacturing.

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XTalks

MAY 30, 2023

The VTT Technical Research Centre of Finland has addressed this issue by developing a fully recyclable, modular ECG patch constructed from VTT’s novel cellulose e-skin material. Unfortunately, about 91 percent of this plastic waste from healthcare is not recycled and either ends up in landfills or contaminates natural environments.

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XTalks

JUNE 14, 2022

Researchers at the Karolinska Institutet in Sweden developed a new nano-sensor for detecting pesticides on produce in a matter of minutes. To overcome this, we developed inexpensive and reproducible nano-sensors that could be used to monitor traces of fruit pesticides at, for example, the store.” .

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XTalks

MAY 11, 2023

Related: Abbott Baby Formula Plant Under Investigation by the DOJ Symptoms of Cronobacter Sakazakii Infection Infants are particularly vulnerable to Cronobacter sakazakii infections, as their immune systems are still developing and their digestive tracts are not fully formed.

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XTalks

MAY 13, 2021

Since the material can change color in response to different stimuli, the researchers believe this discovery can also be used to advance the development of anti-counterfeiting technologies and stretchable electronics. “A Related: MIT Scientists Develop Food Sensor That Can Detect Spoiled or Contaminated Food.

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pharmaphorum

JUNE 8, 2022

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 Bioprocess Research & Development. Cleanroom Managers. Regulatory Affairs Managers. Production Managers. Quality Systems Managers.

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XTalks

SEPTEMBER 13, 2022

In April, the FSIS announced that the New Jersey-based company Lakeside Refrigerated Services was recalling over 120,000 pounds of ground beef products that may be contaminated with E. The public health alert comes as some federal health authorities in the country are investigating an outbreak of E. While most E.

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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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XTalks

NOVEMBER 2, 2021

It also found detectible levels of phthalates in food handling gloves, which researchers said could be a source of contamination. The study found higher levels of chemicals in fast-food items containing meat, such as hamburgers and chicken burritos, while cheese pizza had the lowest levels.

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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. Routine food safety inspections experienced significant disruptions throughout the pandemic.

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XTalks

MAY 18, 2023

Cornell University researchers have been making strides in the development of a revolutionary tool to combat dangerous pathogens in commercial dry food manufacturing plants. Steam is also employed for sterilizing equipment and preventing contamination during packaging processes. Their solution? Superheated steam. Instances of E.

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pharmaphorum

OCTOBER 7, 2020

The Pharmaceutical Microbiology Conference East Coast Virtual Conference will be commencing on 28th and 29th October 2020 and will focus on technological developments that push innovation and tackle the most pressing challenges in the world of pharmaceutical microbiology. María José (Pepa) Lopez Barragán is a former U.S.

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XTalks

FEBRUARY 21, 2022

The BioNTainers will not only be equipped to manufacture BioNTech’s COVID-19 vaccine, but also other mRNA vaccines to address the needs in Africa, such as BioNTech’s investigational malaria and tuberculosis vaccines if they reach successful development and approvals.

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The Pharma Data

DECEMBER 30, 2020

Britain became the first country to give authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. Using the contaminated mouthwash can result in “oral and, potentially, systemic infections requiring antibacterial therapy.

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XTalks

JUNE 5, 2023

Related: World Food Safety Day 2022: Theme, History and Ways to Get Involved The HACCP system traces its roots to the 1960s, developed initially by the National Aeronautics and Space Administration (NASA) and Pillsbury to provide safe, long-lasting food for space missions.

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FDA Law Blog

DECEMBER 13, 2021

Subpart E of the PSR was specifically developed to address agricultural water quality control. The regulated industry criticized the complexity and the one-size-fits-all approach of Subpart E. susceptibility of the produce to surface adhesion or internalization of contaminants); Environmental conditions (e.g., 26, 2022.

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The Pharma Data

NOVEMBER 10, 2020

coli O157:H7 strain found by Michigan Department of Agriculture and Rural Development (MDARD) in Tanimura & Antle brand packaged single head romaine lettuce. 15 or 16 due to possible contamination with E. coli O157:H7 outbreaks that occurred in 2019 resulting in contamination of romaine lettuce in the Salinas Valley growing area.

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FDA Law Blog

JULY 29, 2024

The draft guidance first addresses the kinds of information applicants should develop and collect so that they can evaluate the effects that post-manufacturing changes might have on their products’ identity, strength, quality, purity, or potency. Part 601 delineates those changes as being either major, moderate, or minor.

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FDA Law Blog

NOVEMBER 30, 2022

According to the Realtor, these CIP qualification discrepancies “may lead to contamination” and “…over time [lead to] to adulterated [Gamunex] product and significant risk of patient harm.” These CIP equipment qualification reports were provided to the FDA in support of its PAS and PAI to approve the new facility.

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