Material Handling Featured Articles
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Stability Chambers: Testing, Equipment, And Uses
3/7/2023
Performing stability studies is a critical step in the drug development process. Discover the ways to ensure that your drug is safe and effective as it goes to market.
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How Lipid Nanoparticles Overcome Solubility Challenges
3/7/2023
More than 80% of NCEs are poorly soluble compounds. Overcoming this challenge using lipid nanoparticles is essential to move your drug product through the pipeline and into the market.
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Lyophilization Contract Manufacturing Services: What To Know
3/7/2023
Explore the best ways to optimize your lyophilization cycle and the benefits of partnering with an experienced pharmaceutical contract manufacturing services provider.
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New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices
2/15/2023
The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.
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What Is Contributing To The API Shortage?
2/8/2023
No, you can’t have your cake and eat it, too. In this case, your “cake” is a 6-cents-worth generic pill. We have seen a precarious competitive situation with generic drug manufacturing for several years now; what are the key trends and their impacts on the pharma supply chain? Let's investigate.
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Tips To Maintain Your Pharmaceutical Tablet Presses And Tooling
1/31/2023
Implementing a cleaning procedure is essential to maintaining tablet tooling and presses. Clean tooling reduces product cross-contamination risk and decreases premature wear.
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EMA's Revised GMP Annex 1 Addresses Common Global Challenges For Sterile Products
1/18/2023
The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.
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ICH Final Q13 Guideline For Continuous Manufacturing: What It Means
12/16/2022
The International Council for Harmonisation released the final draft of its Q13 guideline for continuous manufacturing. It's yet another signal that global regulators see tremendous potential in CM. Here are the key takeaways.
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Cleanroom Gowning Programs Compliant With EU GMP Annex 1
12/15/2022
Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.
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Pharma Process Validation: Initial Conclusions Are Often Deceptive
9/26/2022
As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.