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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Regulation Compliance Contamination Marketing 52

pharmaphorum

JULY 22, 2022

for an Improved, Efficient and Contaminant-Free Cleanroom. In 2025, the global cleanroom technology market is expected to reach nearly $5 billion. From the new operating practices that keep the product as sterile as possible, to the developments in technology that are enabling this to happen. Advances in Pharma 4.0

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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. It has licensed in a patented breathalyser, the analysts noted.

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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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FDA Law Blog

JANUARY 1, 2024

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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Manufacturing Production Drugs FDA Compliance 59

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 Production Managers.

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Pharmaceutical Technology

OCTOBER 26, 2022

Data indicates that the global nanopharmaceutical drugs market size reached USD 53.85 According to GlobalData’s Nanopharmaceuticals Thematic Research report, the vast majority of marketed and pipeline nanopharmaceuticals are being used to treat a wide range of cancer indications, highlighting the ongoing unmet needs in this area.

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XTalks

AUGUST 21, 2020

The device will be able to detect if a product is organic or not and whether it is safe. One way to prevent this is for designated agencies to judge the quality of smartphone measurements, as more food testing technologies come on the market. Many other countries, including the US, have their own controls and regulations for olive oil.

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Regulation Big Data Contamination Production 110

XTalks

JUNE 7, 2022

The day emphasizes the importance of making food safety a priority for all to stay healthier and be more productive, which will in turn help reduce the pressure on health care systems. They are caused by bacteria, viruses, parasites or chemical substances entering the body through contaminated food or water.

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Contamination Bacteria Regulation Development 98

XTalks

OCTOBER 16, 2023

Similarly, in Wyoming, the Department of Health confirmed that five people — one adult and four children — fell ill after ingesting raw milk purchased from Slow Food in the Tetons online market. State investigators linked the illnesses to raw milk or its products but have not yet identified the specific vendor involved. Coli bacteria.

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XTalks

JULY 12, 2023

The worldwide fish and seafood market, worth $624.20 Enhanced processing, refrigeration, ice production and transportation methods have significantly broadened the commercialization and distribution of fish in diverse product forms over recent decades. percent between this year and 2028. For detecting such minute bones, a 0.05

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Contamination Containment Production Manufacturing 52

Roots Analysis

OCTOBER 24, 2023

HPAPIs, due to their selective mode of action, are effective in much smaller quantities than other therapeutic products. This has led to their widespread production and extensive use in the treatment of various indications including hormonal imbalances, oncological disorders and respiratory disorders.

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XTalks

AUGUST 3, 2021

The National Council of Negro Women (NCNW) filed a lawsuit last week asking courts to make Johnson & Johnson create equally targeted “corrective marketing,” and/or fund outreach efforts warning Black women and their families about the risk of ovarian cancer associated with its product.

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Containment Production Contamination Marketing 98

XTalks

AUGUST 31, 2020

The study, “ Seeding of outbreaks of COVID-19 by contaminated fresh and frozen food ,” was published in the journal BioRxiv which circulates preliminary findings that have not been scrutinized by peer review. Related: Garden Gourmet’s Plant-Based Tuna Exploits Market ‘White Space’. “An

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FDA Law Blog

OCTOBER 31, 2021

SB 343 adds additional requirements; it requires that California’s Department of Resources Recycling and Recovery (CalRecycle) update regulations that require disposal facilities to provide information on recycling data. g)(4) of the California Public Resources Code; or.

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Packaging Packaging Containment Production 52

XTalks

APRIL 14, 2023

Last month, Impossible Foods recalled its Chicken Nuggets Made from Plants and Wild Nuggies because of the possibility of small pieces of wood in the products. Consumers who may have purchased the products covered by the recall should dispose of them immediately and avoid consuming them.

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Production Containment Contamination Bacteria 52

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

JANUARY 25, 2023

Abbott, the maker of Similac and other popular baby formula brands, was forced to recall several powdered infant formulas and stop production after the US Food and Drug Administration (FDA) found evidence of unsanitary conditions. Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner?

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Bacteria Contamination Production Regulation 52

pharmaphorum

JULY 21, 2022

The pharmaceutical industry has long been highly regulated to help ensure quality and safety across all aspects of its business. As a result, some businesses have been forced in the last 18 months to make risk-based decisions based on the resources available to them rather than the quality assurance of a product. She has a Ph.D.

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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. . . Regulatory intelligence activities are complicated by the push for stronger product sales in emerging markets.

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Development Contamination In-Vitro Production 52

pharmaphorum

MARCH 22, 2022

for manufacturing, with the aim of streamlining and enabling greater automation through adoption of digital tools, is leading to greater interest in the potential for VR and AR to improve efficiency and reduce costs in production. The pharma industry’s overall push into industry 4.0 The importance of manufacturing.

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Drug Discovery World

OCTOBER 5, 2022

The market is growing strongly as accelerated technological, material, and methodological developments expand the potential applications for 3D bioprinting. RA: How regulated is bioprinting and is there more work needed with regulators to make it more accessible? Volume 23 – Issue 4, Fall 2022. .

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Drugs Regulation Manufacturing Medicine 52

XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy. Container closure systems are highly regulated by health agencies.

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Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Host cell proteins (HCPs) – proteins derived from the host cells used for viral production—are one class of process-related impurities.

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Production Gene Protein Vaccination 52

Delveinsight

SEPTEMBER 8, 2021

Especially in the field of Pharmaceutical & Life Sciences, a company’s all-around product life-cycle stages, which consist of planning, designing, constructing, product testing, and commissioning processes are provided by a Pharma Consultant. In a nutshell, Consultants can be considered as fixers, serving as troubleshooters.

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Marketing Production Sales Life Science 52

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. Different ISO standards are required depending on the processes and products developed within the environment. Meeting strict standards. Enter cleanrooms-on-demand….

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Pharmaceutical Technology

FEBRUARY 3, 2023

When you consider the existing challenges limiting the upstream production of viral vectors, this figure becomes even more alarming. Cell culture challenges The viral vectors used in the gene therapies currently on the market are produced in adherent human embryonic HEK-293 cell culture. CEVEC became part of Cytiva in October 2022.

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XTalks

FEBRUARY 8, 2024

Understanding the market dynamics of diabetes treatments becomes crucial for professionals across these industries. Both drugs continue to dominate the diabetes and GLP-1 markets. In 2022, Januvia was flagged for nitrosamine contamination , a potential carcinogen commonly produced as a byproduct during drug manufacturing.

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Sales Insulin FDA Approval Drugs 52

FDA Law Blog

MAY 19, 2023

Baumhardt, Senior Medical Device Regulation Expert & Richard A. Continuous Monitoring and Post Market Reporting Special Controls Within the Special Control for Risk Analysis are details regarding continuous monitoring.

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Reagent Genetics Contamination Marketing 40

XTalks

MAY 30, 2023

The healthcare industry has one of the heaviest environmental footprints, and manufacturers are increasingly faced with regulations to make more sustainable products,” said Mohammad H. The Global ECG Patch Market The global ECG patch and holter monitor market , estimated to be around $13 billion and projected to grow at a 17.5

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Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

pharmaphorum

JUNE 28, 2022

Gilead Sciences has refiled for FDA approval of its HIV capsid inhibitor lenacapavir – which only needs to be dosed every six months – after the drug was rejected by the regulator in February. Yescarta matches Kymriah in Europe. Both therapies are already used for this use in the US.

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Drug Discovery World

AUGUST 10, 2022

By Mark White, Associate Director of Biopharma Product Marketing at Bio-Rad and Marwan Alsarraj, Biopharma Segment Manager, Digital Biology Group. Exactly three decades later, the first CAR T cell therapy hit the market. For example, it is challenging to regulate transgene copy numbers in each T cell, posing safety risks.

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Manufacturing Gene Genome Genomics 98

XTalks

MAY 13, 2021

Related: MIT Scientists Develop Food Sensor That Can Detect Spoiled or Contaminated Food. Improved testing methods could not only be a huge cost saver for the industry, but also help reduce food waste and guarantee safe products for retailers and consumers. This is not the first artificial material designed to enhance seafood safety.

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Contamination Scientist Marketing Bacteria 59

Roots Analysis

MAY 24, 2024

In addition, various combination products have been approved / are currently under development for the treatment of various therapeutic indications, such as rheumatoid arthritis, diabetes, psoriasis, psoriatic arthritis and multiple sclerosis. Drug Device Combinations Autoinjectors are considered as single entity combination product.

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XTalks

SEPTEMBER 20, 2023

When it comes to sustainable production and the future of the food industry, the solution could lie somewhere in between. The company is set to scale up its production, hinting at the future potential of cultivated meats. Israel-based Steakholder Foods predicts that the first wave of commercial meat products is likely to be hybrids.

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Contamination Protein Production FDA Approval 64

Pharmacy Checkers

NOVEMBER 21, 2019

As my greater advocacy initiatives have worked to implore the FDA to bring more balance, commonsense and fairness to regulating and providing consumer education about personal imports of prescription drugs, I’ve realized that I should practice the same in how I talk about the FDA. The medications that we obtain in the U.S., Far from it.

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XTalks

JUNE 22, 2023

The Rethink Plastic alliance, in collaboration with a coalition of 81 organizations, is advocating for the integration of effective reuse systems into the European Union’s (EU’s) Packaging and Packaging Waste Regulation. The success of The Better Bagel reflects the growing market demand for low-carb and keto-friendly products.

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Packaging Packaging Containment Contamination 52