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Active Pharmaceutical Ingredients (APIs) A substance used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings.
Video
Mastering Controlled Temperature Chambers: Qualification, Mapping, and Monitoring in GxP Environments
Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour This webinar offers a…
Video
Implementing X-Ray for Single-Use Systems Sterilization: Current Status
Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour Sterilization by gamma…
News
ISPE Announces Leaders from Health Canada, AltruBio, AstraZeneca, Gilead, Lonza, Lyndra, and More to Speak at the 2023 ISPE Annual Meeting & Expo
The International Society for Pharmaceutical Engineering (ISPE) announced eight keynote speakers for…
PE Articles
Continuous Manufacturing of Small Molecule Drug Substances
The adoption of continuous manufacturing (CM) in the pharmaceutical industry is increasing because…
Product
Baseline Guide Vol 1: Active Pharmaceutical Ingredients
This revised Guide builds on the original principles of ISPE’s Baseline® Guide Volume 1, Active…
Product
Good Practice Guide: Operations Management
For the purposes of this Guide, operations are defined as the transformative process within a series…
Basic page
2023 Category Winner for Innovation
Chugai Pharma Manufacturing Co., Ltd. Location: Shizuoka Pref, Japan Project: FJ2 Project Chugai…
Product
ISPE Readiness Report Bundle
Report on ISPE Work to Support Establishment of the European Union Health Emergency Preparedness and…
iSpeak Blog
Innovations: The Future of Pharmaceutical Facilities
Opening keynote addresses at the 2023 ISPE Facilities of the Future Conference focused on innovation…
iSpeak Blog
Implementing & Ensuring Robust Contamination Control
The ISPE Aseptic Conference is back and in-person for 2022! We have a great line-up of speakers…
PE Articles
Effect of Gum on in Vitro Dissolution of Powder for Oral Suspension
Powder for oral suspension (PfOS) bioavailability is mostly on the basis of drug absorption from the…
PE Articles
Material Properties Databases to Advance Pharmaceutical Processing
Pharmaceutical manufacturers rely heavily on powder processes, the majority of which are designed…
Guidance Documents
Active Pharmaceutical Ingredients (3)
Drug Shortages (1)
Good Manufacturing Practice (1)
Project Management (1)
Supply Chain Management (1)
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Pharmaceutical Engineering Magazine Articles
Continuous Manufacturing of Small Molecule Drug Substances
The adoption of continuous manufacturing (CM) in the pharmaceutical industry is increasing because…
Effect of Gum on in Vitro Dissolution of Powder for Oral Suspension
Powder for oral suspension (PfOS) bioavailability is mostly on the basis of drug absorption from the…
Material Properties Databases to Advance Pharmaceutical Processing
Pharmaceutical manufacturers rely heavily on powder processes, the majority of which are designed…
A New Pharmaceutical Equipment Exposure Measurement Database
This article describes the Pharmaceutical Equipment Exposure Measurement Database (PEEM-DB), which…
