Material Handling Featured Articles

  1. FDA Issues Second DSCSA Warning Letter — What Does This Mean? 8/16/2023

    In June 2023, shortly before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met come November, the FDA issued a warning letter to Safe Chain Solutions, LLC addressing DSCSA violations related to repeated instances of distributing costly counterfeit antiviral drugs that Safe Chain had sourced from unauthorized trading partners. Let's look more closely at the emerging themes so that you can avoid a similar warning letter.

  2. Financial Leadership Of Strategic Procurement: 4 Foundational Steps 8/2/2023

    Efficiently managing a diverse supply base is crucial for drug companies to maintain growth, profitability, and compliance. While the procurement function can be organized under various executives, the relationship between the CFO, procurement, legal, and buying departments is very important.

  3. Tablet Tooling Nutraceutical Products 7/25/2023

    How can you reduce tooling wear and problems caused by abrasive ingredients during your tablet manufacturing process?

  4. Intro to USP <1062> — What Is Tabletability? 7/20/2023

    What is tabletability, and why is it important for creating tablets that can survive the journey from manufacturing to packaging?

  5. Key To Formulation Development Is In The Details 7/20/2023

    Find out how to face the challenges in tablet manufacturing environments through supportive vendor partnerships.

  6. Preparing A Framework For Artificial Intelligence And Machine Learning Validation: A 3-Step Approach 7/20/2023

    Experts say it would be foolish to ignore the impending AI/ML revolution. There's official guidance out there now on how to prepare, but waiting for a full framework from regulators would be a mistake. This article lays out some strategies for building a foundation to implement AI/ML into your processes.

  7. Addressing 3 Challenges Using The Tablet Press Automatic Weight Control System 7/20/2023

    Three serious issues have arisen in using tablet press automatic weight control systems. For example, we may encounter excessive start-up sampling when manufacturing small batch sizes, resulting in exceeding the maximum allowable loss and triggering an investigation. This expert discusses this point and two other issues.

  8. Streamline Early-Stage Development To Reach The Clinic Faster 7/17/2023

    Early-stage development is an iterative process, continuously generating new data and insights to optimize the product based on emerging knowledge.

  9. A Micronization Method Enabling The Formulation Of Biopharmaceuticals 6/29/2023

    See how applying lyophilization-based micronization methodology at a small scale helps to support challenging formulation development projects.

  10. ICH Q12 Post-Approval Change Management Protocol 6/27/2023

    The ICH Q12 guideline includes information about the post-approval change management protocol, which aims to simplify the process of registering site changes under certain criteria through an emphasis on gaining accelerated up-front feedback from the regulator before compiling submissions. Following this protocol reduces the approval cycle by up to six months.