Featured Pharma Online Editorial

51. 5 Key Considerations For MES Vendor Selection 10/20/2023

    Have you made a strategic business decision to implement a manufacturing execution system (MES)? Selecting a MES vendor is a strategic and thoughtful process. With these five considerations, you can give some thought to how MES fits into your enterprise landscape and your business requirements.

52. How To Lose A Batch In 10 Days 9/25/2023

    Inspired by the rom com How to Lose a Guy in 10 Days, this article spotlights the critical missteps that could lead you to lose a batch during the manufacturing process. By identifying these pitfalls, the author guides you toward best practices that will not only save your batches but also improve the quality, efficiency, and reliability of your operations. 

53. Have You Adopted A Manufacturing Execution System Yet? 9/7/2023

    Manufacturing execution systems (MES) have become crucial in managing bio/pharmaceutical operations to ensure compliance and promote efficiency. This article shares the benefits of adopting a MES, the three deployment options, manufacturing applications for MES, and more.

54. 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.

55. 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.

56. 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.

57. 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.

58. Navigating The Pros And Cons In Annex 1's PUPSIT Requirements 7/12/2023

    Annex 1 made Pre-use Post Sterilization Integrity Testing, or PUPSIT, a requirement, and enforcement has begun in earnest over the last few years. This article digs into the problems that downstream filter manipulation can cause and questions whether the risks outweigh any benefits.

59. Key Considerations In Selecting A Robotic Solution For Endotoxin Testing 7/6/2023

    The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.

60. 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.