Content focuses on feature key components and the financial impact of supply and distribution chains. Topics focus on the systems required to control and automate the receipt, storage, and dispensation of raw and packaging materials and the storage and distribution of finished products. Other topics could include materials management, operational economics, and warehouse and distribution management.
iSpeak Blog
Get Inspired: Watch These 2025 Session Highlights Ahead of the 2026 Facilities of the Future Conference
Explore three insightful sessions on the future of pharmaceutical facilities from thought leaders…
iSpeak Blog
Engineering Companies as a Driving Force in the Implementation of Pharma 4.0™: Strategy, Challenges, and Partnerships
The evolution of pharmaceutical manufacturing has progressed through several stages—from manual drug…
iSpeak Blog
New ISPE Good Practice Guide: Advanced Therapy Medicinal Products (ATMPs) – Equipment Design and Qualification for Cellular Products
The rapid rise of cellular therapies is transforming modern medicine and creating new challenges for…
News
ISPE Ire GAMP & Pharma4IR- "Shaping the future of Pharma" Seminar
ISPE Ireland GAMP & Pharma4IR Seminar Date: Thursday, 12 February 2026 Location: Greenway Manor…
News
CHEManager covers the Key Pillars of Successful Digital Transformation in Pharma with ISPE Pharma 4.0™ Members
ISPE Pharma 4.0™ Community of Practice (CoP) members Michelangelo Canzoneri, Hans Heesakkers, Teresa…
PE Articles
GAMP® in Today's Digital Landscape
As the pharmaceutical landscape continues to evolve, this issue highlights use of AI and GAMP ®…
Video
Leveraging Generative AI for Audit and Regulatory Response Development
Leveraging Generative AI for Audit and Regulatory Response Development Complimentary Learning Level…
iSpeak Blog
Watch Mike Martin, President and CEO of ISPE, Discuss How to Prepare the Future Workforce on the Life Science Rundown Podcast
Mike Martin, President and CEO of ISPE, recently connected with Nicholas Kapman, President and CEO…
PE Articles
Meet the ISPE Staff: Gabriela Kantor
In each issue of Pharmaceutical Engineering ®, we introduce a member of the ISPE staff who provides…
PE Articles
Digital Manufacturing and Supply: An ISPE D/A/CH Workshop
The 2025 ISPE D/A/CH workshop on “Pharma’s Journey to Digital Manufacturing and Supply” united…
PE Articles
New ISPE Guide: ATMPs – Validation Methods and Controls Throughout the Cell and Gene Therapy Lifecycle
Advanced therapy medicinal products (ATMPs) represent a revolutionary frontier in medicine, offering…
PE Articles
New ISPE Good Practice Guide Helps Support CM Adoption
The newly published ISPE Good Practice Guide: Control Strategy Development for Continuous…
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Peer Companies Share Knowledge on Calibration Management in Recent Asset Management Benchmarking Session
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From Paper to Pixels: Why Pharma Needs to Digitalize Piping and Instrumentation Diagrams (P&IDs) and How to Make It Happen
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Sino Biopharmaceutical Acquires Hangzhou Hygieia Biomedical
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AbbVie Licenses RemeGen Cancer Drug For $650M
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AbbVie Pledges To Invest $100B In US R&D Over Next 10 Years
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Lapse Of Funding Mechanism Threatens Biotech Innovation In US
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US FDA Eases Manufacturing Rules For Cell, Gene Therapies
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CBER Priorities Include CAR T, CGT Guidance
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Nvidia Expands Into AI For Biotech
- Construction Progressing On Seran Biosciences Plant
Pharmaceutical Engineering Magazine Articles
New ISPE Good Practice Guide Helps Support CM Adoption
The newly published ISPE Good Practice Guide: Control Strategy Development for Continuous…
Expand Your Knowledge and Network at ISPE Annual Meeting & Expo
As professionals in pharmaceutical engineering, we are challenged to develop medications and…
Single-Use Technology Waste in Manufacturing Operations
Single-use products used in the production of biologics provide flexibility that was unimaginable a…
Plastic Process Waste in Biopharmaceutical Manufacturing
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical…
Global Convergence Opportunities
The regulation of drug shortage prevention has rapidly changed over the past several years due to…
Digital Display Labeling in Clinical Supplies for Clinical Trials
Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the…
ATMP-Focused Online Seminars Educate and Inspire
The field of advanced therapeutic medicinal products (ATMPs) has witnessed remarkable advancements…
Delivering Curative Therapies: Autologous vs. Allogeneic Supply Chains
Advanced therapy medicinal products (ATMPs) are one of the most promising developments in the…
Considerations for a Decentralized Manufacturing Paradigm
The biopharmaceutical industry must develop and implement innovative ways of working to be effective…
ISPE Briefs: ISPE Initiatives Provide Guidance on Medicines Supply
ISPE task teams created reports and a model to examine the challenges surrounding drug shortages…
Regulatory Landscape for Raw Materials: CMC Considerations
A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients…
Supplier Qualification Program for Key Raw Materials
With the publication of recent guidance, specifically the US FDA Quality Systems Approach to…
White Papers
March / April 2023
As the pharmaceutical industry faces ever-changing global challenges and market forces, it must…
Videos
Professional Development Training
GMP Fundamentals: Holding & Distribution
In this course, you will learn the requirements for storing, handling, and distributing finished products to ensure they are stored properly and not contaminated or altered during transport. For a limited time, registration fees are waived for this course. Included in the GMP Refresher Certificate Program The ISPE Academy’s comprehensive GMP Certificate program includes a mandatory GMP refresher course and allows learners to customize their learning experience by selecting two out of eleven GMP Fundamentals modules. Learn More and Register Interactive Course: What to Expect CEUs are provided…
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