XTalks

AUGUST 26, 2024

Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. In this episode of the Xtalks Food Podcast, Sydney talks about how lead contamination in food can arise and what the FDA is doing to monitor lead levels. per share in an all-cash transaction.

Contamination 52

Contamination Branding Compliance Regulation 52

Advarra

SEPTEMBER 14, 2023

GxP in Clinical Trials To yield the best possible outcomes for clinical trials, GxP guidelines and compliance regulations assures regulatory agencies the safest and most productive research efforts are being delivered to the market. GDP is Key to Maintaining Compliance Want to instill confidence in your GxP?

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

Pharmaceutical Technology

JUNE 14, 2023

The number of high-potency drug approvals has increased over the last decade, driven by the increasing use of APIs (Active Pharmaceutical Ingredients) in the pipeline and among marketed drugs. Containment challenges and opportunities High containment facilities guard against exposure to extremely potent products and cross-contamination.

Containment 130

Containment Manufacturing Contract Manufacturing Bioavailability 130

XTalks

AUGUST 11, 2023

The global market for healthcare facilities management is on an upward trajectory, growing from $176.83 Healthcare facilities management roles can be categorized into distinct areas: Operations, Maintenance, Security, Compliance and Facility Development. billion in 2022 to a forecasted $199.78

Compliance 96

Compliance Contamination Production Marketing 96

pharmaphorum

OCTOBER 7, 2020

FDA regulator and founder of Barragan BioConsulting, where she offers Regulatory and Compliance consulting services to pharmaceutical companies globally. During my presentation, I will discuss about humans as ecosystems and how they pose a source of contamination risk during the manufacture of biopharmaceuticals.

Contamination 52

Contamination Production Manufacturing Compliance 52

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. And June?

Development 52

Development Contamination In-Vitro Production 52

FDA Law Blog

OCTOBER 31, 2021

Furthermore, under the new law, the use of the chasing arrow symbol itself will be a misleading environmental marketing claim in advertising or on a product label unless the product meets the standard of “recyclable.”. g)(4) of the California Public Resources Code; or. Finally, SB 343 provides that resin identification code numbers (e.g., #1

Packaging 52

Packaging Packaging Containment Production 52

Pharmacy Checkers

DECEMBER 12, 2019

A majority of inspections resulted in findings of non-compliance. 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. The EU already mandates full compliance with the Falsified Medicines Directive (FMD).

Drugs 71

Drugs Manufacturing Medicine Regulation 71

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. This is extremely important for injectable medications.

Drug Delivery 40

Drug Delivery Contamination Drugs Production 40

Roots Analysis

APRIL 15, 2024

It is worth noting that, any discrepancies encountered at this stage of manufacturing can lead to microbial contamination, subsequently resulting in loss of product, long development timelines and substantial financial burden for the drug developers, owing to the high cost of cell-derived raw materials.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

Roots Analysis

MAY 24, 2024

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 ). This is extremely important for injectable medications.

Drug Delivery 40

Drug Delivery Containment Contamination Production 40

The Pharma Data

NOVEMBER 18, 2020

Services for safely containing, emptying, transporting and treating human waste, and preventing pits and septic tanks from contaminating groundwater and open drains are needed, but without regulation, investments will not prioritize public health outcomes. In these areas, regulators are insisting on improved sector outcomes.

Regulation 52

Regulation Compliance Contamination Marketing 52

FDA Law Blog

JUNE 17, 2024

Claud — FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S. By Kalie E. Richardson & John W.M. are safe, effective, and meet appropriate quality standards.

Manufacturing 59

Manufacturing Drugs Production Contamination 59

Roots Analysis

JANUARY 12, 2023

However, there are several hurdles associated with the transition of cell-based therapy products from laboratory to clinical scale, such as regulatory compliance, lack of advanced facilities and infrastructure. The key steps involved in the supply chain of cell therapies manufacturing are presented below.

Manufacturing 40

Manufacturing Production Contamination Medicine 40

Roots Analysis

SEPTEMBER 20, 2023

However, there are several hurdles associated with the transition of cell-based therapy products from laboratory to clinical scale, such as regulatory compliance, lack of advanced facilities and infrastructure. Contamination is a key concern when it comes to manufacturing cell therapy products.

Manufacturing 40

Manufacturing Production Contamination Gene Therapy 40

The Pharma Data

NOVEMBER 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. She earned a BA from Durham University, U.K., and an MBA from Harvard Business School. Most recently, she was a senior executive at Celgene Corporation, where she led corporate strategy from 2012 to 2017.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

FDA Law Blog

MAY 19, 2023

Continuous Monitoring and Post Market Reporting Special Controls Within the Special Control for Risk Analysis are details regarding continuous monitoring. Labeling Special Controls The labeling may seem like the easiest Special Control for demonstrating compliance.

Reagent 40

Reagent Genetics Contamination Marketing 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?

Compliance 52

Compliance Manufacturing Regulation Marketing 52

XTalks

MAY 13, 2022

Curia is a global contract research, development and manufacturing organization (CDMO) that specializes in drug discovery, spanning the entire product lifecycle from target to lead candidate identification, development, manufacturing feasibility, through to commercialization and post-marketing. > umbrella).

Packaging 98

Packaging Packaging Containment Production 98

Pharmaceutical Technology

MARCH 30, 2023

At the start of this year, the World Health Organisation (WHO) said that more than 300 children had died in The Gambia, Indonesia and Uzbekistan in 2022 in deaths linked to contaminated medicine. The medicines – over-the-counter cough syrup – were contaminated with ethylene glycol (EG) and diethylene glycol (DEG).

Compliance 130

Compliance Manufacturing Contamination Medicine 130

Pharmaceutical Technology

MAY 17, 2023

One big challenge is contamination. It can cost millions of dollars to remove contamination from a manufacturing process and this causes a consequent delay to the preparation of the drug. As with contamination, variation in outcomes and product quality are often a result of the raw materials used.

Insulin 130

Insulin Production Manufacturing Contamination 130

pharmaphorum

AUGUST 4, 2022

In a job market characterised by talent shortages, the onus is on businesses to provide the workforce with attractive job opportunities. For instance, in pharmaceutical manufacturing, mistakes in training can lead to contamination or waste, which can cause businesses unnecessary headaches.

Development 98

Development In-Vitro Manufacturing Compliance 98

pharmaphorum

DECEMBER 23, 2022

The drug was rejected by the US regulator earlier this year a few months after the programme was placed on a clinical hold amid concerns about the drug’s manufacturing, specifically issued related to the possibility of sub-visible particulate contamination from the borosilicate glass vials that were originally used to produce the drug.

FDA Approval 52

FDA Approval Contamination Marketing RNA 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. 7, 2022 at 1 p.m.

Contamination 52

Contamination Production Manufacturing Packaging 52

FDA Law Blog

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. market complaints in 2021 through 2023 but could not provide documentation to demonstrate how the complaints were reviewed or evaluated. Dextrum Laboratories Inc.

Manufacturing 59

Manufacturing Production Drugs Contract Manufacturing 59

Pharmaceutical Technology

APRIL 27, 2023

LNPs are an adaptable, modular technology and when combined with microfluidic mixing, have the potential to accelerate development and commercialisation timelines and provide drug developers with an early foothold into a largely untapped market.

Manufacturing 130

Manufacturing RNA Contamination Vaccination 130

Roots Analysis

FEBRUARY 1, 2024

Enhance predictive maintenance, remote monitoring, compliance, and fleet management by incorporating the sensor data with supply chain. Microbial contamination due to poorly maintained freezers and fridges. Track and trace all the cold chain temperature controlled packaging products using a single technology platform.

Packaging 40

Packaging Packaging Containment Production 40

Roots Analysis

OCTOBER 16, 2023

It involves the separation of unwanted particles from biological materials to obtain contaminant free products. Biopharmaceutical filtration systems are designed to remove impurities and contaminants, to improve safety, purity and shelf life of the product. Particle Removal: This is the primary function of these filtration systems.

Bacteria 40

Bacteria Production Protein Contamination 40

FDA Law Blog

MARCH 9, 2025

The American Conference Institutes 12th Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care is scheduled to take place from March 27-28, 2025, at the New York City Bar Association, New York, NY. FDA Law Blog is a conference media partner.

Cosmetics 59

Cosmetics Compliance Contamination Regulation 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.

Manufacturing 52

Manufacturing Development Contamination Production 52