XTalks

MAY 13, 2022

A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. They provide specific guidance on packaging requirements for closed closure integrity (CCI) and general integrity testing. Container Closure Systems. Container closure systems are highly regulated by health agencies.

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Packaging Packaging Containment Production 98

Drug Patent Watch

FEBRUARY 19, 2025

From inspecting manufacturing facilities to testing finished products, QA teams work tirelessly to guarantee that every pill, tablet, or capsule that reaches the market is safe and effective. These dedicated individuals play a critical role in ensuring that generic drugs meet the same high standards as their brand-name counterparts.

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Generic Drugs Drugs Contamination Manufacturing 87

XTalks

FEBRUARY 5, 2021

There are a variety of materials that are used for food packaging, and they serve some very important functions in the food industry. Many of the foods purchased by consumers today are contained in packaging made from materials such as paper, plastic, metal or glass. One of the hallmarks of food packaging is the single-use design.

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Packaging Packaging Contamination Containment 64

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. Namely, these include the backlogs and hassle associated with working with CDMOs or CMOs to develop new products and bring them to market. The future of COD.

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Manufacturing Pharma Packaging Production Packaging 98

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

MAY 11, 2008

Data has long been incorporated into drug packaging to accomplish these goals, but only to a partial degree with embossed lot numbers, expiry dates and even Braille identification in addition to linear bar codes. For example, Turkey will require track and trace by 1 January 2009 and California is requiring the technology by 1 January 2011.

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Drugs Packaging Packaging Production 100

XTalks

DECEMBER 1, 2021

The US Food and Drug Administration (FDA) estimates that nearly 48 million people are sickened by food contaminated with harmful germs each year, with produce being the culprit in many cases. However, it appears to be the first and only at-home food safety testing device on the market. Where the gadget will fit into the $19.5

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Contamination Packaging Packaging Regulation 98

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. This push aims to mitigate waste produced by single-use plastic takeaway packaging.

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Packaging Packaging Containment Contamination 52

XTalks

MAY 30, 2023

XTALKS WEBINAR: Drug Delivery — Addressing Global Regulatory Challenges in Co-Packaged, On-Body Systems Live and On-Demand: Thursday, June 15, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn about on-body drug delivery systems and addressing their complex global regulatory requirements.

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Drug Delivery Drug Delivery Systems Manufacturing Contamination 98

FDA Law Blog

OCTOBER 31, 2021

Under SB 343, a product or packaging is not recyclable in California if: It includes components, inks, dyes, adhesives, or labels that prevent its recyclability; It contains intentionally added chemicals identified pursuant to regulations implementing section 42370.2(g)(4) g)(4) of the California Public Resources Code; or.

Packaging 52

Packaging Packaging Containment Production 52

XTalks

MAY 16, 2024

Several chains expanded their market reach and others innovated to adapt to evolving consumer preferences. Approximately one in every 25 chicken packages at grocery stores is contaminated with Salmonella. Last year, the American fast-food industry experienced significant transformations.

Regulation 52

Regulation Contamination Packaging Packaging 52

Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Simplicity matters. Bioburden and microbial testing. an antibiotic).

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Production Manufacturing Development Bioequivalency 130

Pharma in Brief

AUGUST 9, 2021

The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. Manufacturing Controls. On-site Evaluations.

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Regulation Drugs Manufacturing Production 98

Roots Analysis

APRIL 15, 2024

Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.

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Manufacturing Production Contract Manufacturing Contamination 40

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, they require adequate cleaning and sterilization before reuse, thereby increasing costs.

Drug Delivery 40

Drug Delivery Contamination Drugs Production 40

Pharmacy Checkers

DECEMBER 12, 2019

The European Union (EU) has similar challenges to us when it comes to drug safety, including inspections of the plants that make pharmaceuticals for the European market. FMD requires that every single prescription drug dispensed in the EU must be verified for authenticity via a mandatory 2D barcode on the packaging.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. This includes the rising number of biologic drugs on the market, which are mostly administered parenterally.

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Contamination Packaging Packaging Manufacturing 130

Roots Analysis

FEBRUARY 1, 2024

Further, the cold chain storage process involves the cold chain storage, cold chain transportation, and monitoring temperature controlled packaging products. Therefore, the pharmaceutical, biotech, food and chemical industries usually rely on cold chain packaging for the transportation of their products.

Packaging 40

Packaging Packaging Containment Production 40

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

Contamination 98

Contamination Packaging Packaging Containment 98

Pharmaceutical Technology

FEBRUARY 3, 2023

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. Two-Plasmid Packaging System for Recombinant Adeno-Associated Virus. link] [2] Tang Q, et al. Biores Open Access. 2020 Oct 16;9(1):219-228. doi: 10.1089/biores.2020.0031.

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Genome Genomics Medicine Gene Therapy 244

Pharmaceutical Technology

DECEMBER 8, 2022

Forward-thinking suppliers, including packaging component providers, are also looking at how they can improve their processes through digital technologies. Tom Lenaerts is head of global process engineering for Datwyler, a leading supplier of parenteral packaging components such as stoppers and plungers. Free Whitepaper. By Datwyler.

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Manufacturing Packaging Packaging Production 246

XTalks

MAY 3, 2024

Related: New Rapid Salmonella Test Could Accelerate Poultry Safety Protection for Consumers: Should Salmonella exceed allowed levels, the affected products will be withdrawn from the market to safeguard consumers from the severe health risks these infections pose. Other food products can also be contaminated with Salmonella.

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Regulation Production Contamination Packaging 103

Pharmaceutical Technology

JANUARY 12, 2023

That would not allow sufficient time to manufacture, package and distribute before half of the content was degraded. Download this whitepaper to find out more about oncology trends and how Baxter’s oncology contract manufacturing facility in Halle, Germany, minimise the risk of cross contamination. A great example is aspirin.

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Production Contamination Development Manufacturing 130

Roots Analysis

SEPTEMBER 29, 2023

Closed System – To ensure that there is no chance of contamination or leakage of liquid nitrogen used for freezing and storage of goods, single-use bags can be fully sealed and vacuum packed. Easy access to material : To prevent contamination during sample withdrawal, functionally closed access systems must be implemented.

Contamination 40

Contamination Containment Biobanking Production 40

Cloudbyz

AUGUST 19, 2024

Manufacturers must adhere to a wide array of standards and guidelines that dictate how devices are developed, tested, and brought to market. Compliance with their regulations is mandatory for manufacturers seeking to market their devices globally. What is the role of post-market surveillance in medical device safety?

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Compliance Manufacturing Regulation Marketing 52

pharmaphorum

JUNE 16, 2021

At the same time, living in environments plagued with construction pollution, industrial fumes, and contaminated water, interferes with a child’s mood stability, behavior, and neurological development. Social injustice, poverty, and lack of access to whole foods create nutritionally toxic and depleted food environments.

Medicine 52

Medicine Packaging Packaging Contamination 52

FDA Law Blog

NOVEMBER 22, 2022

coli contamination. Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region. Two days before Thanksgiving the following year, the CDC warned U.S. Concurrently, the U.S.

Contamination 52

Contamination Production Manufacturing Packaging 52

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

The Pharma Data

FEBRUARY 19, 2022

The impacted products originated from the company’s distribution facility in West Memphis, Arkansas, where an FDA inspection found insanitary conditions, including a rodent infestation, that could cause many of the products to become contaminated. Recalls, Market Withdrawals & Safety Alerts Report a Problem to the FDA. ###.

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Contamination Production Cosmetics Packaging 52

FDA Law Blog

MARCH 9, 2025

John Claud will speak at a session titled Beauty in Developing World Markets: Contrasting Opportunities and Challenges in the Latin American and Chinese Cosmetics Markets, where he will explore two areas of global focus for the cosmetics industry: Latin America and China. FDA Law Blog is a conference media partner.

Cosmetics 59

Cosmetics Compliance Contamination Regulation 59

FDA Law Blog

MARCH 30, 2025

Increased Testing for Contaminants : To enhance safety, FDA will increase testing for heavy metals and other contaminants in infant formula, as well as other foods commonly consumed by young children. Infant Formula Market that FDA announced in January.

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Contamination Packaging Packaging Development 59

XTalks

NOVEMBER 1, 2024

This approach to meat production offers a low-emission alternative to livestock farming and aims to hit the Singapore market soon, paving the way for eco-conscious meat options. This oven’s AI-driven features also offer insights into temperature regulation and nutrient preservation.

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Containment Contamination Bacteria Packaging 105

FDA Law Blog

DECEMBER 14, 2023

They observed that unregulated cannabis products have been found to contain fentanyl, high levels of heavy metals, contaminants, and even high delta-9 tetrahydrocannabinol (“THC”) concentrations.

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Regulation Production Drugs Contamination 59

XTalks

JANUARY 28, 2025

In 2023, the OSD market was approximately $36.5bn, and is poised to register a compound annual growth rate (CAGR) of around 6% to the year 2030. For highly potent APIs, roller compaction significantly reduces the risk of airborne contamination and cross-contamination, ensuring a safer working environment and enhancing operator safety.

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Manufacturing Development Contamination Production 52

XTalks

SEPTEMBER 14, 2020

All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. The package is made up of a €390 billion fund in grants and a €360 billion in low interest loans. ECONOMIC IMPACT: Canada.

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Vaccination Vaccine Antibody Life Science 92