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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Students and Recent Graduates: Join us at the 2025 ISPE International Emerging Leader Hackathon
The 2025 ISPE International Emerging Leader Hackathon is your chance to tackle real-world industry…
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Quality Risk Management Commissioning & Qualification: Key Deliverables & Lessons Learned Webinar
Quality Risk Management Commissioning & Qualification: Key Deliverables & Lessons Learned Webinar…
iSpeak Blog
Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 1 – Materials and Components
Introduction: Part 1 Cleanroom garments are worn by operators working in certified cleanrooms to…
Product
GAMP Guide: Artificial Intelligence
Published: July 2025 Pages: 290 Table of Contents Special Pricing for Emerging Economies…
iSpeak Blog
Validation 4.0 for the Pharmaceutical Industry
The pharmaceutical industry is under increasing pressure to develop new therapies at a faster pace…
iSpeak Blog
Sustainability Meets Strategy: Shape the Future of Pharma™ at the 2025 ISPE Annual Meeting & Expo
As the pharmaceutical industry evolves, sustainability is becoming a key driver of operational…
PE Articles
Unlock Operational Excellence: Your Roadmap to Asset Performance Management
In an industry where reliability, compliance, and efficiency are non-negotiable, how mature is your…
Video
How to Perform a Compliant Human Error Investigation
How to Perform a Compliant Human Error Investigation Complimentary Learning Level: Advanced Session…
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Effective Process Validation Strategies for Successful Product Commercialization
Effective Process Validation Strategies for Successful Product Commercialization Complimentary…
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ISPE Free Student Membership Application
Are you a student passionate about pharmaceutical sciences, engineering, or biotechnology? Join the…
PE Articles
Streamline Your Pharma Building Infrastructure with Next-Gen Solutions
In the rapidly evolving pharmaceutical landscape, manufacturers face mounting pressure to deliver…
iSpeak Blog
Balancing Speed and Quality in the Construction of Pharmaceutical Facilities
The pharmaceutical industry is no stranger to innovation. From pioneering drug development to…
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Guidance Documents
Active Pharmaceutical Ingredients (1)
Drug Shortages (1)
Investigational Products (1)
Packaging (1)
Project Management (1)
Regulatory (1)
Single Use Technologies & Disposables (1)
Supply Chain Management (6)
Sustainable Facilities, HVAC, & Controlled Environments (1)
Community Discussions
Community Discussions
Jul 15, 2025
Manufacturing Operations
Oral Solid Dosage
Jul 08, 2025
Information Systems
Artificial Intelligence
Data Integrity
Jul 08, 2025
Pharma 4.0™
Jun 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Jun 19, 2025
Quality
Lifecycle Management
Validation
May 22, 2025
iSpeak Blog Posts
Webinars
ISPE in the News
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Search and Post Jobs at ISPE’s Career Center
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Regulatory Innovation and Global Collaboration highlighted at the ISPE Europe Annual Conference
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Partnership Aims to Automate Cell Therapy Manufacturing
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FDA Posts 200 Complete Response Letters
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Playbook Helps Prepare for Unannounced Inspections
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How Data Can Prevent Supply Chain Failures
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Arkema to Expand Polyamide Production in Singapore
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Nigeria Aims to Grow Pharma Industry to $10B
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Myrtelle Begins Manufacturing for Gene Therapy
- Advanced Manufacturing Can Give Edge to US Pharma
Pharmaceutical Engineering Magazine Articles
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…
Operational Risk Management in Global Supply Scenarios
The current regulatory framework in the pharmaceutical industry places pressure on marketing…
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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