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.
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Mastering Controlled Temperature Chambers: Qualification, Mapping, and Monitoring in GxP Environments
Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour This webinar offers a…
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Implementing X-Ray for Single-Use Systems Sterilization: Current Status
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The adoption of continuous manufacturing (CM) in the pharmaceutical industry is increasing because…
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Baseline Guide Vol 1: Active Pharmaceutical Ingredients
This revised Guide builds on the original principles of ISPE’s Baseline® Guide Volume 1, Active…
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Good Practice Guide: Operations Management
For the purposes of this Guide, operations are defined as the transformative process within a series…
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2023 Category Winner for Innovation
Chugai Pharma Manufacturing Co., Ltd. Location: Shizuoka Pref, Japan Project: FJ2 Project Chugai…
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ISPE Readiness Report Bundle
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Innovations: The Future of Pharmaceutical Facilities
Opening keynote addresses at the 2023 ISPE Facilities of the Future Conference focused on innovation…
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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…
PE Articles
A New Pharmaceutical Equipment Exposure Measurement Database
This article describes the Pharmaceutical Equipment Exposure Measurement Database (PEEM-DB), which…
Guidance Documents
Active Pharmaceutical Ingredients (3)
Drug Shortages (1)
Good Manufacturing Practice (1)
Project Management (1)
Supply Chain Management (1)
Community Discussions
Community Discussions
Nov 04, 2024
Regulatory
Supply Chain
Active Pharmaceutical Ingredients
Good Manufacturing Practice
Oct 23, 2024
Quality
Active Pharmaceutical Ingredients
Good Manufacturing Practice
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…
