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
Introducing the ISPE Artificial Intelligence (AI) Community of Practice (CoP) Applications, Models, and Data Subcommittee: Pioneering Responsible AI in GxP Environments
Used correctly in the pharmaceutical industry, artificial intelligence (AI) has the possibility to…
Video
Real Life Case Studies featuring ML/AI including Predictive Maintenance, Defect Detection, Environment
Real Life Case Studies featuring ML/AI including Predictive Maintenance, Defect Detection…
iSpeak Blog
Igniting Innovation in the East: Reflections on ISPE’s Launch in China
A Message from the President and CEO, ISPE A New Chapter for ISPE in China: Reflections from…
Basic page
Communities of Practice Resources
Expand All GAMP® Resources Marketing Resources ISPE General PPT - GAMP - Template GAMP ® Logos Your…
Product
Good Practice Guide: Validation 4.0
The Validation 4.0 Guide provides a comprehensive approach to ensuring product quality and patient…
Video
How to Perform a Compliant Human Error Investigation
How to Perform a Compliant Human Error Investigation Complimentary Learning Level: Advanced Session…
Video
Effective Process Validation Strategies for Successful Product Commercialization
Effective Process Validation Strategies for Successful Product Commercialization Complimentary…
Basic page
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…
PE Articles
How Validation Is Evolving in 2025: Key Trends Revealed
Validation professionals are under pressure — from rising workloads to new regulatory demands…
PE Articles
Elevating High-Purity Piping: The SYGEF PVDF Advantage
In the world of pharmaceutical and life sciences manufacturing, purity, reliability, and performance…
iSpeak Blog
Introducing the ISPE Artificial Intelligence (AI) Community of Practice (CoP) Applications, Models, and Data Subcommittee: Pioneering Responsible AI in GxP Environments
Used correctly in the pharmaceutical industry, artificial intelligence (AI) has the possibility to…
Video
Real Life Case Studies featuring ML/AI including Predictive Maintenance, Defect Detection, Environment
Real Life Case Studies featuring ML/AI including Predictive Maintenance, Defect Detection…
iSpeak Blog
Igniting Innovation in the East: Reflections on ISPE’s Launch in China
A Message from the President and CEO, ISPE A New Chapter for ISPE in China: Reflections from…
Basic page
Communities of Practice Resources
Expand All GAMP® Resources Marketing Resources ISPE General PPT - GAMP - Template GAMP ® Logos Your…
Product
Good Practice Guide: Validation 4.0
The Validation 4.0 Guide provides a comprehensive approach to ensuring product quality and patient…
Video
How to Perform a Compliant Human Error Investigation
How to Perform a Compliant Human Error Investigation Complimentary Learning Level: Advanced Session…
Video
Effective Process Validation Strategies for Successful Product Commercialization
Effective Process Validation Strategies for Successful Product Commercialization Complimentary…
Basic page
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…
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
Jun 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Jun 19, 2025
Quality
Lifecycle Management
Validation
May 22, 2025
Apr 24, 2025
Validation
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
iSpeak Blog Posts
Webinars
Upcoming
On-Demand
ISPE in the News
Latest
-
Navigating Innovation: The United Kingdom's (UK) Evolving Regulatory Landscape
-
ISPE Training: Storage, Delivery, and Qualification Pharma Water, Online Live, 22-23 July
-
ISPE SmartBrief will not be published July 4
-
Startup Produces Recombinant Proteins with Silkworms
-
Iraq Sets Pharmaceutical Production Goal
-
AbbVie to Acquire CAR T Therapy Developer for $2.1B
-
U of Okla. Opens Bioprocessing Training Facility
-
Aenova Builds Refrigerated Warehouse in Latina, Italy
-
Risk-based Cleaning Process Qualification Minimizes Samples, Runs
- Sigachi Pharma Chemicals Plant in Telangana, India, Catches Fire
Pharmaceutical Engineering Magazine Articles
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…
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…
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…
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
+Featured Conferences