Contributing Editors
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Pacesetters Are Product Innovators Who Embrace Digital Process Enhancement
12/12/2023
The Josh Bersin Company recently underwent research examining pharma/biotech “pacesetters” in the field. We caught up with Jordan Schmitting, senior research analyst at The Josh Bersin Company, to discuss the trends illuminated by the research.
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Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices
12/11/2023
The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is the first comprehensive guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, endotoxin residues, and visual residues.
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Drug Labeling: 3 Pitfalls To Avoid And 8 Best Practices To Follow
12/7/2023
You may have processes in place to prevent drug labeling errors, but they can still occur. Here are three common pitfalls and the eight best practices you should be employing to make sure they don't happen.
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FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities
12/5/2023
In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.
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Designing Facility Monitoring Systems For Cleanrooms
12/4/2023
Let's examine the features and advantages of facility monitoring systems, system architecture considerations, and overall system considerations.
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How Can Digital Twins Get Us Closer To Pharma 4.0?
11/28/2023
Digital twins — virtual representations of physical and conceptual assets, processes, or systems — offer a seamless bridge between the present challenges and the vision of Pharma 4.0.
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Your 6 Priority Areas For A Successful 2024
11/27/2023
As we approach the end of 2023, and pharma/biotech companies finesse their road maps for 2024, this article assesses the six priorities vying for attention.
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Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical Packaging
11/21/2023
Counterfeit medicines are rising at an alarming rate, with data showing that nearly 6,500 pharmaceutical crime incidents were recorded in 2021, ranging from innovator drugs to generics, and from antimalarials to blood pressure medicine to vaccines. What packaging and labeling strategies are pharma/biotech companies using to tackle this?
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Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs
11/20/2023
Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.
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A Brief Introduction To Environmental Monitoring For Startups
11/17/2023
Environmental monitoring is a crucial part of the pharma, biotech, and medical device field to indicate that the microbial particulate content of all cleanroom air and work surfaces is below acceptable levels. For new startups with a small number of employees wearing many hats, you might not have a deep understanding of what kind of monitoring is available, so this article shares an introduction.