Featured Pharma Online Editorial

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Are We Adequately Assessing U.S. Pharma Supply Chain Risks? 6/26/2020

    There are gaps in our country’s collective knowledge required to determine the severity of the current pandemic’s risk to our supply chain for drugs. Undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry.

  8. DSCSA, Blockchain, & The Pharma Supply Chain — Where Do Things Stand? 5/27/2020

    As the requirements for serialization and track & trace become more challenging to implement as we approach 2023, blockchain, by providing data integrity throughout the supply chain, becomes a more attractive solution to reducing the probability of errors occurring.

  9. COVID-19's Impact On Availability Of Drugs And API From India And China 4/23/2020

    COVID-19 has caused an increase in demand for APIs and drugs; those used as antimalarials are seeing the highest demand, followed by bronchodilators, antibiotics, and antivirals. This article reviews the drugs and API in demand globally, with assessments of their supply status in India and China.

  10. Helping Pharma Manufacturers Overcome DSCSA Interoperability Pain Points 4/13/2020

    With the FDA guidance documents and requirements of the Drug Supply Chain Security Act still unfolding, there is a growing need for sectors in the supply chain to align on how to meet various aspects of the law.