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.
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.
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European Pharmaceutical Review
APRIL 8, 2025
Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Figure 1 : Process analytical technology implementation in (bio)pharmaceutical GMP manufacturing. Sustainability. 2020; 12(3), 981. Lezotre PL.
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.
Putting Patients First Blog
AUGUST 2, 2023
Since its first iteration, PAHPA has been reauthorized every five years — once in 2013 and again in 2019 — in a typically bipartisan manner; the current iteration of PAHPA expires on September 30 of this year.
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