European Pharmaceutical Review
JULY 5, 2023
The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.
European Pharmaceutical Review
MARCH 11, 2024
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.” According to the authors, these were linked to 55 fatal cases of fungal meningitis.
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Express Pharma
MARCH 16, 2025
and Europe held manufacturers accountable for their environmental impact, leading to an increase in partnerships with tech companies focused on sustainable packaging and production solutions. Regulatory bodies in the U.S. Finally, reshoring and localised production emerged as key strategies for improving supply chain resilience.
National Association of Boards of Pharmacy
SEPTEMBER 16, 2022
When Food and Drug Administration (FDA) enacted the Drug Supply Chain Security Act (DSCSA) in 2013, it set a 10-year timeline for full implementation. One requirement that is included in Title II of the Act calls for product tracing at the package level, which had not been explored widely by the industry until recently.
FDA Law Blog: Biosimilars
AUGUST 27, 2023
As industry is well aware, by the terms of the statute, the DSCSA’s interoperability provisions become effective ten years after its 2013 enactment, or on November 27, 2023. the ability to associate the saleable return product with the transaction information/statement with the particular product). Guidance at 4. So what is FDA going to do?
FDA Law Blog: Biosimilars
MARCH 27, 2023
Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.
European Pharmaceutical Review
OCTOBER 24, 2023
2013 ) Target genes for siRNA in AD Decades of research have unveiled multiple genes associated with the onset and pathogenesis of AD. Furthermore, dendritic polymers are being studied as critical delivery systems for treating neurodegenerative diseases and have been proven effective in delivering intact siRNA to the desired target sites.
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