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Pharmaceutical Technology, October 2021 Issue
Automating Aseptic Manufacturing
October 03, 2021
Cover Story
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Conventional and robotic automation inside closed systems reduces risk.
Considering Bio/Pharma Reformulation Strategies
October 03, 2021
Development
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Reformulation strategies are useful tools for more than just stretching out the potential return on investment for a product.
Pharma Sets a Foundation for Greener API Manufacturing
October 03, 2021
Development
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Drug makers are going beyond continuous improvement and green chemistry to increase the sustainability of small-molecule manufacturing.
Adopting Continuous Manufacturing for Solid-Dose Drug Products
October 03, 2021
Manufacturing
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Evolving equipment designs meet the unique needs of continuous processing techniques.
Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 1. Conventional SPC Rules and Pharmaceutical Process Data
October 03, 2021
Peer-Reviewed Research
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10
Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.
Determining Shelf Life: Reading the Stability Testing Data
October 02, 2021
Analytics
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10
Although stability testing programs for small-molecule drugs and biologics are often perceived as similar, stability programs for biologics are far more complex.
Trends Affecting Biopharmaceutical Manufacturing
October 02, 2021
Outsourcing
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Almost half of pharmaceutical industry profits continue to come from biopharmaceuticals.
European Pharmacopoeia Updates: EDQM Tackles Nitrosamine Impurities
October 02, 2021
Quality/Regulations
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10
Updates to Ph. Eur. include validated tests for N-nitrosamine impurities in sartan APIs.
Public Trust in Medicine Quality as Public Health Challenges Emerge
October 02, 2021
Quality/Regulations
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10
Public health challenges have highlighted the need for agility in maintaining the quality of medicines.
FDA Moves to Advance Innovative Excipients
October 02, 2021
Regulatory Watch
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A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.
New Beginnings
October 02, 2021
From The Editor
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Change of roster does not change the goal line. We are all patients first.
The Basics of Aseptic Processing
October 02, 2021
Ask the Expert
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10
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.