Content focuses on process equipment, the design of facilities, and utility systems that support the critical physical and chemical requirements of drug products, in addition to other aspects of the product specification. Topics include design and construction/installation, commissioning and qualification, operation and maintenance, controls, and automation.
Guidance Documents
Advanced Manufacturing (3)
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+Validation (1)
+Community Discussions
Community Discussions
May 22, 2025
Apr 24, 2025
Validation
Apr 16, 2025
Information Systems
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Artificial Intelligence
Apr 08, 2025
Data Integrity
Apr 07, 2025
Advanced Manufacturing
Artificial Intelligence
Mar 28, 2025
Information Systems
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Advanced Manufacturing
Artificial Intelligence
White Papers
July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
July / August 2023
Continuous manufacturing (CM) challenged regulators’ expectations and regulatory frameworks. This…
May / June 2023
North Carolina’s Research Triangle is the largest of its kind in the US. Thanks to years of effort…
May / June 2022
Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to…

Pharmaceutical Engineering Magazine Articles
Professional Development Training
Good Engineering Practice (GEP) Training Course
+GMP Fundamentals: Eleven-Part Bundle Series
+Biopharmaceuticals: Webinar C> e ATMP
+Produtos Biofarmacêuticos: Aspectos CMC
+GMP Fundamentals: Packaging & Labeling Control
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