Featured Pharma Online Editorial
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Certifying Exports: A Roadmap To EMA’s Certificate Of Medicinal Product
2/8/2021
In Part 1 of this series, we discussed requirements for exporting U.S.-manufactured material to foreign markets supported by an FDA-issued certificate of pharmaceutical product. Here in Part 2, we will explain how to export EU-manufactured product to foreign markets leveraging a certificate of medicinal product issued by the European Medicines Agency.
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Certifying Pharma Exports: Intro To FDA’s Certificate Of Pharmaceutical Product
2/1/2021
<p>When exporting human drugs, manufacturing facilities are often asked by foreign customers or governments to provide documentation of the facility’s compliance with FDA standards. In Part 1 of a two-part article, we discuss the requirements for exporting U.S.-manufactured material to foreign markets leveraging a certificate of pharmaceutical product (CPP) issued by the FDA. </p>
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What Role Will India Play In The Global COVID-19 Vaccine Narrative?
1/27/2021
While most Americans are focused on the incredible success of the COVID-19 vaccines developed and produced by Pfizer and Moderna under the $24 billion Operation Warp Speed, there is under-reported news from India that bears a closer look.
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6 Things We Need From FDA Before Full 2023 DSCSA Enforcement
1/6/2021
This article suggests concrete actions the FDA can take to help unify a complex and diverse group of stakeholders prior to enforcing the full requirements of the Drug Supply Chain Security Act (DSCSA) in Nov. 2023.
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Is It Time To Stop Using Mean Kinetic Temperature (MKT) In Pharma Storage & Transport?
12/28/2020
MKT continues to be proposed in USP chapters <659> and <1079> and is presented as an isothermal storage temperature that simulates the non-isothermal effects of storage temperature variation. However, there is too little or no emphasis on the physics or chemistry behind the impact of temperature excursions on biological drug products and other contemporary drugs.
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Mitigating Risks To Global Distribution Of COVID-19 Vaccines And Therapeutics
11/20/2020
Supply chain challenges posed by COVID-19 must be assessed and mitigated. Increased monitoring and CAPAs of supply chain issues and technical support for analytical challenges need to be addressed.
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Are You Prepared For The U.S. Enhanced Drug Distribution Security (EDDS) Requirements?
10/5/2020
The initial requirements of the Drug Supply Chain Security Act (DSCSA) were deliberately structured and timed to allow industry to thoughtfully design and implement the required capabilities in preparation for the pinnacle requirement, which goes into effect on Nov. 27, 2023: the implementation of Enhanced Drug Distribution Security (EDDS) capabilities.
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Hazmat Regulations: What Life Sciences Companies Need To Know
9/25/2020
It is important for life sciences companies to understand the regulations laid out in the U.S. Department of Transportation’s 49 CFR Parts 100-185 — and their impact on package design and testing requirements, training requirements, and packaging and handling hazardous materials in bulk and non-bulk forms.
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What The Antibiotic Shortage Teaches Us About API Supply Disruptions
7/17/2020
The COVID-19 pandemic has highlighted the need to reevaluate API manufacturing partners, and we may see companies shift to a more regionally diverse supply chain, including an appropriate mix of localized and global capabilities to meet specific market needs.
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Is The U.S. Ready For A Re-shored Pharma Supply Chain?
7/2/2020
In the first part of this two-part article, we looked at how dependent the U.S. pharmaceutical supply chain is on critical ingredients produced in China and India and the risk that could pose to the nation’s drug supply. In this article, we will examine potential solutions to mitigate those risks and ensure the nation’s drug supply is secure.