Featured Pharma Online Editorial

  1. Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances 7/5/2021

    In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.

  2. How To Use DMF Content To Support Your Application To The FDA 4/30/2021

    A drug master file (DMF) is a voluntary regulatory application submitted to the U.S. FDA. It is used to provide confidential detailed information about the manufacturing, processing, packaging, and storing of APIs and/or human drugs. What are the types of DMF submissions, what is involved, and how does the FDA evaluate your submission?

  3. Biopharma Cold Chain Logistics 101 4/9/2021

    Cold chain logistics can be complex and intricate. Maintaining the integrity of controlled-temperature products requires holistic consistency between design and development, manufacturing and packaging, qualification and validation, cold storage, transportation, and monitoring as the product moves from its point of origin to the end user.

  4. 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.

  5. 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&rsquo;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.&nbsp;</p>

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.