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.
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Pharmaceutical Online Covers the 2026 ISPE Facility of the Year (FOYA) Awards Category Winners
During the 2026 ISPE Europe Annual Conference, ISPE announced the 2026 FOYA Category Winners. The…
iSpeak Blog
Electrical Area Classification in Biotech Manufacturing Facilities Part Three: From Research and Development (R&D) to Manufacturing
In the previous installments of this series ( Part One and Part Two), we discussed the development…
News
The Globe and Mail Highlights Sanofi’s Sustainability Efforts, Mentions Sanofi as a 2025 FOYA Category Winner
Sanofi’s Canadian operations are undergoing a major transformation as the global biopharmaceutical…
iSpeak Blog
Workforce Preparedness and Organizational Readiness Take Center Stage at the 2026 ISPE AI in Life Sciences Summit – Powered by GAMP®
AI is no longer a future concept for life sciences—it is a present-day force reshaping how medicines…
iSpeak Blog
Investing in the Next Generation: Our Shared Responsibility
This post is Part 3 of the Jack Lysfjord Grant blog series. Read Part 1 and Part 2.
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ISPE Plagiarism Policy
Purpose The International Society for Pharmaceutical Engineering (ISPE) is committed to upholding…
iSpeak Blog
Science, Technology, and Spirit: Insights from the 2026 ISPE MAST Showcase
The ISPE Mid-Atlantic Science and Technology Showcase (MAST) in Baltimore, Maryland, USA held on 7…
News
Med Device Online Highlights 2026 ISPE Europe Annual Conference Keynote: “Stronger Together: A One Team Mindset to Building a Global Aseptic Manufacturing Network”
During the 2026 ISPE Europe Annual Conference, Syed Abbas Yar‑Khan, Group Vice President, Global…
iSpeak Blog
Celebrating Excellence in Pharmaceutical Manufacturing: FOYA Insights from the 2026 ISPE Europe Annual Conference
The Facility of the Year Awards (FOYA) Category Winners announcement was once again a cornerstone…
iSpeak Blog
Inside FUJIFILM Biotechnologies: A Post Event Recap of the Sold Out Facility Tour Following the 2026 ISPE Europe Annual Conference
As a fitting conclusion to the 2026 ISPE Europe Annual Conference, 30 conference attendees took the…
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FDA 483 Resources
An FDA Form 483 (Inspectional Observations) is issued to company management at the end of an FDA…
Video
Critical Quality Attributes - Validation of an Automated Glassware Washer and Depyrogenation Tunnel
Critical Quality Attributes - Validation of an Automated Glassware Washer and Depyrogenation Tunnel…
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ISPE in the News
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Applying Large Language Models (LLMs) in GMP Regulated Biotech IT Compliance: A Case Study
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Pharmaceutical Engineering Magazine Articles
Unique Challenges of Radioligand Therapy Manufacturing
Radiopharmaceuticals account for many lifesaving diagnostic and therapeutic drug products in the…
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…
White Papers
March / April 2023
As the pharmaceutical industry faces ever-changing global challenges and market forces, it must…
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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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