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

Delveinsight

SEPTEMBER 8, 2021

There are several challenges faced by any company entering or persisting in the market, few of which are managerial, statistical, financial, and analytical decisions to be made by a client organization for which they would require people possessing more knowledge in the specified field that can serve as an advantage.

Marketing 52

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. And even once the facility is fit for purpose, specialised staff are required to maintain compliance with strict regulations. Meeting strict standards.

Manufacturing 98

Manufacturing Pharma Packaging Packaging Packaging 98

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. Labeling Special Controls The labeling may seem like the easiest Special Control for demonstrating compliance.

Reagent 40

Reagent Genetics Contamination Marketing 40

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

Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard. Why do I write “exact same”?

Drugs 71

Drugs Manufacturing Medicine Compliance 71

XTalks

MAY 13, 2022

Container closure systems are highly regulated by health agencies. USP and EP Organizations for Container Regulation. E&L testing is performed to substantiate that packaging materials will not contaminate the drug product over a product’s shelf life. shaking, changes in pressure, etc.). > umbrella).

Packaging 98

Packaging Packaging Containment Production 98

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

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