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
Redefining Quality Through AI Innovation
As industries across the globe navigate increasing complexity, consumer expectations, and regulatory…
iSpeak Blog
Data-Driven Quality: Turning Insights into Action at the 2025 ISPE Pharma 4.0™ Conference
In Pharma 4.0™, quality should no longer be reactive—it’s predictive, connected, and embedded in…
iSpeak Blog
Positioning Commissioning and Qualification (C&Q) as an Integrated Value-Driven Activity in Project Delivery and Beyond
C&Q forms a critical connection between the construction phase and operational readiness of…
PE Articles
How Data Center Construction Lessons Can Transform Pharma Projects
Across the country, data centers are being constructed at incredible speed. Pharmaceutical…
PE Articles
Optimize Production and Distribution in Life Sciences
Smarter software, better supply chains: Optimize production and distribution from lab to delivery…
PE Articles
Navigating USP <1221>. What the New Guidelines Mean for Analytical Laboratories
This whitepaper explores the principles behind USP 1221>, how it aligns with related global…
PE Articles
The Importance of Keeping Laboratory Software Updated
Laboratories rely heavily on digital solutions to power their workflows and as a result of this, the…
Video
Future-Proofing Pharma & Personal Care: How Life Cycle Assessments & Carbon Footprinting Drive Real Change
Future-Proofing Pharma & Personal Care: How Life Cycle Assessments & Carbon Footprinting Drive Real…
News
ISPE Names CSL Behring the 2025 ISPE Facility of the Year Awards (FOYA) Overall Winner for its Project Aurora Plasma Base Fractionation Facility (Facility F)
CSL Behring has been honored with this prestigious award recognizing innovation and excellence in…
iSpeak Blog
Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning – Part 4: Aseptic Operational Aspects
Introduction Part 4 Cleanroom garments are worn by operators working in certified cleanrooms to…
News
Pharmaceutical Online Highlights the New ISPE Good Practice Guide: Digital Validation
Mark Drinan, Commissioning, Qualification, and Validation Expert at Takeda Pharmaceuticals…
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Oct 31, 2025
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Oct 30, 2025
iSpeak Blog Posts
ISPE in the News
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Fill in the blank: "If the use of leisure time is confined to _____ for a few extra hours every day, we will deteriorate as a people." -- Eleanor Roosevelt, 1958
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ISPE Academy: GAMP® Essentials Certificate
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ISPE Regulatory Initiative: Drug Shortages
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How To Ease AI Anxiety
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Ecolab Introduces New Cleanroom Sporicide
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Monmouth Scientific, IMeBIO Offer Mobile Modular Cleanrooms
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Sandoz Buys Evotec's Toulouse, France, Site
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Gene Therapies May Spur The Body To Make GLP-1
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Pharma Groups Comment On US FDA's PreCheck Program
- Reviving Generics Industry In US Won't Be Easy
Pharmaceutical Engineering Magazine Articles
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…
Drug Shortages: a 30,000 Ft View: Business Continuity Planning for Preventing Drug Shortages
As noted in the ISPE Drug Shortages Prevention Plan, International Society for Pharmaceutical…
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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