Roots Analysis

FEBRUARY 28, 2022

Considering patient’s health and safety, the drug products are expected to be free from microbial contamination and should be safe for use throughout the drug’s life cycle. One of the stages that require quality assurance is packaging of the drug product, as compromised packaging could have serious consequences.

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Containment Packaging Packaging Contamination 52

Pharmaceutical Technology

SEPTEMBER 15, 2022

Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. Adding to these factors is that oncology accounts for the majority of marketed, contained drugs.

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Containment Manufacturing Production Contract Manufacturing 130

XTalks

AUGUST 12, 2024

The presence of lead in food remains a critical concern for the US Food and Drug Administration (FDA). Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. If you want your company to be featured on Xtalks.com, please email sydneyp@xtalks.com.

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Contamination Compliance Regulation Production 105

Pharmaceutical Technology

MAY 11, 2008

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. RFID has other advantages in that it can be used to monitor conditions such as temperature during transport of the drugs.

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Drugs Packaging Packaging Production 100

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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Contamination Containment Production Packaging 98

XTalks

AUGUST 10, 2020

The US Food and Drug Administration (FDA) announced a voluntary phase-out of certain types of grease-proofing agents on paper and paperboard food packaging. As our knowledge of the health effects of PFAS evolves, understanding how they get into our bodies and the environment — where they may contaminate crops and water supplies — is critical.

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Packaging Packaging Contamination Containment 98

Pharma in Brief

AUGUST 9, 2021

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. The proposed amendments require applicants to provide the Minister with an RMP as part of their application for a drug authorization for human use.

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Regulation Drugs Manufacturing Production 98

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

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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Containment Hormones Contamination Packaging 96

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.

Packaging 98

Packaging Packaging Containment Production 98

Pharmaceutical Technology

MAY 10, 2023

Microparticles can be present as a contamination of products such as pharmaceuticals and electronics, or as an air pollutant. Within the pharmaceutical industry, it is critical to measure particle size as it influences surface area and porosity, impacting a drug’s bioavailability, effectiveness, and shelf life.

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Contamination Filler Bioavailability Production 130

Druggist

OCTOBER 4, 2020

Drug treatment can be used alongside lifestyle measures. Most of the drugs which are recommended in the symptomatic management of IBS can be purchased over the counter from pharmacies, supermarkets and online. IBS – drug therapy IBS medications are used for symptomatic management of the condition. Drugs to stop diarrhoea.

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Containment Pharmacy Bacteria Sales 98

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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Vaccine Vaccination Production Manufacturing 105

pharmaphorum

JANUARY 30, 2023

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors is also sustaining new growth and transformation in this field.

Contamination 52

Contamination Manufacturing Production Containment 52

XTalks

MARCH 22, 2024

According to the EWG, about 95 percent of nonorganic strawberries, certain leafy greens (including spinach, kale, collard and mustard greens), grapes, peaches and pears contain detectable levels of pesticides. The EWG also provides a “Clean Fifteen” list , highlighting produce with the least pesticide contamination.

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Contamination Regulation Containment Genetics 109

Druggist

SEPTEMBER 15, 2020

Zovirax cream, marketed as Zovirax Cold Sore Cream, contains 5% of aciclovir. Aciclovir (acyclovir) is an antiviral drug, which stops the production (replication) of the virus at the site of infection. Generic Zovirax cream for cold sores As previously mentioned, Zovirax cream contains 5% of aciclovir. What is Zovirax cream?

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Containment Pharmacy Sales Drugs 98

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.

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Protein Contamination Allergies Bacteria 98

Pharmaceutical Technology

OCTOBER 26, 2022

Data indicates that the global nanopharmaceutical drugs market size reached USD 53.85 Regulations and guidelines for nanopharmaceuticals are still relatively in their infancy, including for cleaning processes and the prevention of cross-contamination. Billion in 2021 and is expected to reach USD 102.4 Billion in 2030.

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Manufacturing Drug Delivery Systems Contamination Drug Delivery 130

Pharmaceutical Technology

APRIL 12, 2023

Evidence suggests that API manufacturing is gaining in complexity, as well as sophistication, and therefore adding to the risk profile of drug development. The ingredients used in these drugs are high potency, even at small doses, and pose a risk to both human health and cross-contamination with other drugs in a manufacturing environment.

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Manufacturing Production Containment Contamination 130

STAT News

NOVEMBER 3, 2022

The companies allege Moderna’s vaccine uses their technology for a drug-delivery system without permission. Citing  Genevant and Arbutus sued Moderna in February, seeking royalties from Moderna’s sale of its Covid-19 vaccine. government should have been brought against the government, not the drugmaker.

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Vaccine Vaccination Drug Delivery Systems Sales 97

pharmaphorum

FEBRUARY 3, 2022

Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. Uncover principles in best-practice and the benefits of a robust contamination control strategy. View the full agenda: [link].

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Contamination Scientist Manufacturing Production 52

Pharmaceutical Technology

APRIL 16, 2023

Autoinjectors have revolutionised the convenient delivery of low-volume parenteral drugs. But with the advent of injection site absorption enhancers, drug delivery device innovations, as well as the recent primary container options, the practical subcutaneous self-administration of large-volume parenterals is becoming possible.

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Protein Containment Drug Delivery Drugs 130

Pharma Packaging Solutions

NOVEMBER 14, 2024

Packaging must prevent interactions between the medication and external contaminants, as well as between the drug and its container. Contaminants can compromise the safety and effectiveness of these products. At Tjoapack, we provide packaging services that uphold the highest standards of sterility and integrity.

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Packaging Packaging Contamination Pharma Packaging 52

XTalks

APRIL 11, 2024

Why Cinnamon is Prone to Higher Lead Levels Cinnamon can become contaminated with lead through various pathways. One primary source is environmental contamination. Additionally, the processing of cinnamon, including drying, grinding and packaging, can introduce lead if the equipment or materials are contaminated.

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Contamination Branding Production Containment 59

The Pharma Data

JANUARY 27, 2021

Food and Drug Administration says. 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. consumers in mind.” ” More Information.

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Containment Contamination Production Regulation 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). Mitigating Cross-Contamination with MenuTrinfo One of the most pertinent concerns for anyone with allergies is the potential for cross-contamination.

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Allergies Manufacturing Contamination Production 98

Roots Analysis

JANUARY 27, 2025

These therapies have emerged as viable alternatives to traditional treatment options, including small molecule drugs. Steps Involved in Cell Therapy Manufacturing Process Manufacturing biologics and cell therapies is considerably complex when compared to small molecule drugs.

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Manufacturing Contamination Production Gene Therapy 40

XTalks

MAY 30, 2023

The patch itself is made of biodegradable nanocellulose and contains no plastic additives. Unfortunately, about 91 percent of this plastic waste from healthcare is not recycled and either ends up in landfills or contaminates natural environments. Plastic accounts for 20 to 25 percent of total waste generated by healthcare facilities.

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Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

pharmaphorum

AUGUST 24, 2020

She served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/OPQ/CDER, responsible for new, generic, and biologic drug product quality review and facility assessment. Key sessions include: • Evaluating the ongoing Complications of Personnel Derived Contaminations.

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Contamination In-Vitro Production Containment 52

FDA Law Blog

JULY 18, 2023

Claud — The Office of Pharmaceutical Quality (OPQ), located within FDA’s Center for Drug Evaluation and Research (CDER), uses global inspection, surveillance, policy, and research activities to set quality standards for drugs. CGMP deviations caused 56 recalls, and excipient manufacturers performed 51 recalls due to contamination.

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Manufacturing Production Contamination Drugs 52

Roots Analysis

MAY 24, 2024

In the dynamic landscape of the healthcare sector, the evolution of drug delivery systems plays a significant role in transforming the management of chronic diseases. They are generally used in combination with primary containers, such as prefilled syringes and cartridges. These allow precise and consistent delivery of a fixed dosage.

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Drug Delivery Containment Contamination Production 40

FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. By Sophia R. Gaulkin & Riëtte van Laack — On May 16, the U.S.

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Containment Contamination Manufacturing Compliance 45

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.

Manufacturing 40

Manufacturing Hormones Contamination Containment 40

XTalks

AUGUST 7, 2023

has received US Food and Drug Administration (FDA) approval for treating molluscum contagiosum in adult and pediatric patients aged two years and older in the US. Transmission of the molluscum contagiosum virus occurs through direct person-to-person contact or via contaminated objects known as fomites. How Does Ycanth Work?

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FDA Approval Dermatology Trials Clinical Trials 98

Roots Analysis

JANUARY 17, 2024

They offer several advantages over traditional drug delivery systems ( such as vials and syringes ), including reduced chances of dosing errors, increased patient compliance and decreased risk of microbial contamination. However, this needle system does not contain a proper locking system, therefore, increased the chances of leakage.

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Drug Delivery Contamination Drugs Production 40

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.” 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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FDA Approval Manufacturing Compliance Contamination 72

The Pharma Data

DECEMBER 28, 2020

(NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company with Phase 3 programs in presbyopia, myopia and mydriasis, today announced that it has submitted a New Drug Application (NDA) to the U. Food and Drug Administration (FDA) for MydCombi , a unique fixed combination mydriatic (pupil dilation) agent.

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Drugs Production Marketing Contamination 52