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Preventing fungal contamination in pharmaceuticals

European Pharmaceutical Review

Additionally, this can be caused by “poor handling, repackaging, and nonadherence to good manufacturing practices [GMP] during dispensing and packaging have resulted in the microbiological contamination of non-sterile pharmaceutical products.” Ahmed et al.

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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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The lingering menace of diethylene glycol / ethylene glycol adulteration

European Pharmaceutical Review

Tamper‑evident packaging is also recommended to prevent adulteration or contamination of the excipient. USP-NF Propylene Glycol Monograph: USP43-NF38, 2010, 3753. 5 Both compounds are limited to ≤0.1 percent or 1,000 ppm. Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act. Ann Intern Med. 24 June 2008.

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Hikma shares rally after US launch of Advair generic resumes

pharmaphorum

Advair lost US patent protection in 2010 and exclusivity on the Diskus inhaler went in 2016 – but it took until February 2019 for the FDA to approve a generic from Mylan, now part of Viatris. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

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Methodology to Define a Pharma 4.0™ Roadmap

ISPE

The goal is to break down complex processes into easy-to-grasp packages, including data privacy and information technology (IT) security. 2010 (IEC 62264-1 Mod): Enterprise-Control System Integration − Part 1: Models and Terminology. 13 May 2010. In the fourth and last step, the defined work packages are executed.

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Foods, supplements, and medicine: the new frontier in chronic disease treatment

pharmaphorum

Salt and sugar are proven to inhibit specific pathways and prevent absorption of a whole package of nutrients important for childhood development. In 2010, President Obama established a task force on childhood obesity, explaining: “We must accelerate implementation of successful strategies that will prevent and combat obesity.

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6 supplements that boost testosterone

The Checkup by Singlecare

A supplement could contain more or less of a stated ingredient, include ingredients not listed on the package, or instruct you to take more than the daily recommended amount for your age and sex. Food and Drug Administration ( FDA ), so you may be taking a risk when you choose to add one to your diet.

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