Liquid Dose Featured Articles
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Dispelling 4 Common Myths Of Data Quality Governance
3/9/2023
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
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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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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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Meeting The Growing Demand For Pre-Filled Syringes
3/7/2023
The market for pre-filled syringes is growing rapidly. Learn more about the benefits for consumers, providers, and manufacturers, and the importance of partnering with a reliable fill finish facility.
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Why It Is Never Too Early To Consider Tungsten Interactions
3/2/2023
A key challenge to sensitive biotechnological or biologic drugs, especially proteins, is the potential presence of tungsten and tungsten oxides from the syringe forming process.
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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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Engineering Advances In Needle Geometry To Accommodate Viscous Biologics
2/1/2023
Explore the challenges faced in administering highly viscous biologics to patients via subcutaneous injection and how new special thin-wall needles are able to tackle them.
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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.