Featured Pharma Online Editorial

  1. Best Practices For Raw Material Supplier Change Notifications: New BioPhorum Guidance 8/27/2021

    Managing the large volume of supplier change notifications while safeguarding the continuity and compliance of a complex and tightly regulated supply chain is a resource-intensive task. To address the challenges, the BioPhorum Raw Material Variability Workstream has developed a guidance document designed to streamline the process without straying from essential and strict risk mitigation procedures.

  2. Best Practices To Ensure Quality Of Raw Materials Used To Manufacture Therapeutic Proteins 8/25/2021

    Across biologics, raw material quality is a key driver of product quality and consistency. This article recaps a recent U.S. Pharmacopeia (USP) workshop on the subject, including recaps of best practices and experiences shared by the FDA, Merck, Biogen, and more.

  3. How Does A Mature QMS = Fewer Drug Supply Chain Disruptions? 8/16/2021

    The FDA’s Office of Quality Surveillance launched a voluntary program to evaluate manufacturers’ quality management systems to inform decisions on the future development of an FDA rating system characterized as quality management maturity. This article explains the importance of QMM and what that looks like to the FDA.

  4. 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.

  5. 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?

  6. 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.

  7. 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.

  8. 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>

  9. 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.

  10. 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.