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

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

DECEMBER 20, 2021

Last Friday, The Coca-Cola Company issued a recall of some of its beverages because the affected products may contain pieces of metal bolts, washers or other foreign objects. 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.

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FDA Law Blog

MAY 23, 2023

the product label declares “tree nut” or “fish” but fails to declare the type of tree nut or species of fish in either the ingredient list or in a separate “Contains” statement). The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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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). 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.

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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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Contamination Production Bacteria Nurses 78

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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XTalks

JULY 26, 2021

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. Since most plant-based meats contain concentrated protein isolates, consumers may receive much higher doses of potential allergens. FDA Regulation.

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XTalks

NOVEMBER 2, 2021

They obtained 64 samples of hamburgers, fries, cheese pizza, chicken burritos and chicken nuggets from various chains and found that over 80 percent contained the phthalate di-n-butyl phthalate (DnBP), while 70 percent contained di(2-ethylhexyl) phthalate (DEHP), both of which have been linked to reproductive health issues.

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Pharmaceutical Technology

OCTOBER 28, 2022

For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve. Even minor amounts of biological contaminants in your sample could cause unwanted biological effects,” Dr Amiji says.

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XTalks

JULY 12, 2023

Despite its prevalent use in the broader food industry, fish bone detection still poses a challenge because fish bones have low density, contain minimal minerals and are incredibly thin, making them difficult to find. Historically, the main reason for installing X-ray equipment was metal contaminant detection.

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Contamination Containment Production Manufacturing 52

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 Led by: Richard Denk, Senior Consultant Aseptic Processing & Containment, Skan AG. View the brochure and to download visit [link].

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Compliance Contamination Manufacturing Production 52

The Pharma Data

JANUARY 27, 2021

During the COVID-19 pandemic, there has been a large increase in hand sanitizers from Mexico that are labeled to contain ethanol (also known as ethyl alcohol) but have tested positive for methanol contamination, according to the agency. Food and Drug Administration says. consumers in mind.” ” More Information.

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Containment Contamination Production Regulation 52

Roots Analysis

OCTOBER 24, 2023

Corticosteroids are produced by adrenal gland and play a role in controlling stress to decrease inflammation whereas, anabolic steroids regulate the manufacturing of testosterone in the testicles and the ovaries. This precaution is taken to prevent any potentially harmful contaminant from escaping the production area.

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XTalks

FEBRUARY 21, 2022

The BioNTainer is housed in shipping containers equipped with state-of-the-art technology for producing the mRNA vaccines from start to finish, except for the final fill-and-finish step that will be performed by local manufacturing partners. Each module contains six standard sized containers, which measure 2.6

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XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.

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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. Finally, SB 343 provides that resin identification code numbers (e.g.,

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Packaging Packaging Containment Production 52

pharmaphorum

SEPTEMBER 23, 2020

The theme of the event is ‘Exploring Agile Contamination Control Strategy’, where the two-day conference will be co-chaired by James Drinkwater, Head of Aseptic Processing Technologies & GMP Compliance, F Ziel GmbH and Jim Polarine, Senior Technical Service Manager, STERIS Corporation. Workshop B 13.30 – 17.30

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Contamination Compliance Containment Regulation 52

XTalks

AUGUST 3, 2021

Johnson and Johnson has faced thousands of lawsuits over its iconic baby powder, which people claim the company knew for decades contained asbestos. Talc and asbestos are often found together in nature, which is why mined talc can contain the carcinogen.

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Containment Production Contamination Marketing 98

XTalks

FEBRUARY 20, 2023

The agency will use the proposed levels to determine whether to take enforcement action against baby food companies with products containing lead over that amount. The study also found that the US does not have strict regulations for commercially produced baby foods that are likely to contain toxic metals.

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Manufacturing Regulation Production Containment 52

XTalks

SEPTEMBER 13, 2022

The meal kits containing ground beef for this public health alert were shipped to consumers from July 2-21, 2022,” the FSIS stated in a public health alert. plastic vacuum-packed packages containing ‘GROUND BEEF 85% LEAN/15% FAT’ with codes ‘EST#46841 L1 22 155’ or ‘EST#46841 L5 22 155’ on the side of the packaging.”.

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Bacteria Packaging Packaging Production 98

Pharmaceutical Technology

OCTOBER 26, 2022

Regulations and guidelines for nanopharmaceuticals are still relatively in their infancy, including for cleaning processes and the prevention of cross-contamination. Within minutes, the system can be removed from the isolator and used in a standard mobile execution if containment is not critical.

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The Pharma Data

DECEMBER 30, 2020

Regulators said that the first dose of the vaccine had 70% effectiveness in protecting against COVID-19 in the period between the first dose taking effect and a second shot. Using the contaminated mouthwash can result in “oral and, potentially, systemic infections requiring antibacterial therapy. Shane Erickson Inc.

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Contamination Vaccination Vaccine Pharmacy 52

XTalks

MAY 30, 2023

The patch itself is made of biodegradable nanocellulose and contains no plastic additives. 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. Behfar, senior scientist at VTT, in the news release.

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Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

XTalks

SEPTEMBER 13, 2021

The technique relies on storing foods in a firm, sealed container made of hard metal or plastic filled with a liquid like water, and placing it in a freezer. Instead, only a small portion of the volume of water in the container is frozen. Another benefit of this method is that it can also kill microbial contaminants during processing.

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Containment Contamination Scientist Research 95

Cloudbyz

AUGUST 19, 2024

Introduction to Medical Device Safety, Systems, and Regulations The medical device industry is a rapidly evolving field that plays a critical role in modern healthcare. This is where the importance of stringent safety processes, robust systems, and comprehensive regulations comes into play. What is the Medical Device Safety process?

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Compliance Manufacturing Regulation Marketing 52

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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XTalks

APRIL 14, 2023

Beyond Meat’s Pennsylvania’s facility had food safety issues in 2021 and 2022, including mold and Listeria contaminations, according to internal documents and photos leaked to Bloomberg. Additionally, photos taken by the former employee from inside the plant show spills, unsafe equipment and mold on the walls and ingredients containers.

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Production Containment Contamination Bacteria 52

XTalks

JANUARY 25, 2023

Related: Baby Food Safety Act of 2021: Why Didn’t FDA Regulate Heavy Metals Sooner? The Abbott baby formula plant was reportedly contaminated with Cronobacter sakazakii , a germ that can be found in dry foods and cause blood infections and meningitis in infants.

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Bacteria Contamination Production Regulation 52

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.”

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The Pharma Data

FEBRUARY 18, 2022

The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if: the first two digits of the code are 22 through 37; and the code on the container contains K8, SH or Z2; and the expiration date is 4-1-2022 (APR 2022) or later. and were likely exported to other countries. Source link: [link].

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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.,

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Generic Drugs Manufacturing Regulation Drugs 68

Roots Analysis

MAY 24, 2024

They are generally used in combination with primary containers, such as prefilled syringes and cartridges. These autoinjectors offer several advantages, including simplified drug administration process, safer injection, reduced risk of contamination and minimized maintenance ( due to elimination of cleaning and sterilization steps ).

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XTalks

NOVEMBER 7, 2022

However, Dr. Bahassi reported that the selection of CTCs using this method is often not very efficient and the CTC population is usually highly contaminated with leukocytes. Exosomes are extracellular vesicles that contain molecular cargoes (such as various proteins, RNAs and DNAs) specific to the origin cell.

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Drug Discovery World

AUGUST 10, 2022

For example, it is challenging to regulate transgene copy numbers in each T cell, posing safety risks. To prevent these potentially fatal side effects, the US FDA recommends that manufacturers who generate CAR T cells using retroviral or lentiviral vectors screen out batches that contain more than four transgene copies per cell 13.

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XTalks

FEBRUARY 8, 2024

In 2022, Januvia was flagged for nitrosamine contamination , a potential carcinogen commonly produced as a byproduct during drug manufacturing. for a pack of three pens, each containing 1.5 While sales remain strong, they have been on the decline. This led to a 15 percent drop in sales compared to the previous year. mL of 300 units/mL.

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Drug Discovery World

MAY 11, 2023

First, products containing undesired proteases can impair drug stability, either by degrading the drug itself or by degrading stabilising excipients of the drug formulation, which ultimately diminishes the drug’s durability. These host cells alone contain over a thousand HCPs. coli, and Pichia cells.

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