Featured Pharma Online Editorial
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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6 Emerging Trends In Pharmaceutical Tablet Coatings
6/26/2023
Tablet coatings have evolved to play a pivotal role in improving the overall appearance, functionality, and stability of tablets. Here are six emerging trends and a look at the overall tablet coatings space.
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Lost CMC Data In An ALCOA+ World
6/19/2023
As technologies advance, the drug/therapy products we make are becoming more complex, and so are their data fingerprints. This article takes a hard look at the way we currently capture and manage chemistry, manufacturing, and controls (CMC) development and manufacturing operations data, and sheds light on how the document-centric mindset of ALCOA+ is not suitable to support the transition to digital CMC and FAIR data management.