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.
Video
QRM Based Integrated C&Q Series - Engineering Change Management
QRM Based Integrated C&Q Series - Engineering Change Management Complimentary Learning Level…
Product
Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (Third Edition)
Published: December 2024 Pages: 122 Table of Contents Special Pricing for Emerging Economies This…
iSpeak Blog
Disaster Recovery in the Pharmaceutical Industry: Lessons Learned from Conflict and Catastrophe
In the pharmaceutical industry, disaster recovery is not just about protecting business continuity…
Basic page
AI Is Here. Harness the Potential with ISPE.
Join Today. Use code AI25Bio to purchase your membership and conference pass in one easy step, and…
Product
Good Practice Guide: Digital Validation
Published: April 2025 Pages: 90 Table of Contents Special Pricing for Emerging Economies This Guide…
Video
AI/ML in Regulated Life Sciences (GxP) Sectors – Operation Phase: Maintaining a State of Control
AI/ML in Regulated Life Sciences (GxP) Sectors – Operation Phase: Maintaining a State of Control…
iSpeak Blog
Validation of an Automated Glassware Washer
The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee continues its…
iSpeak Blog
Trends and Opportunities: How Artificial Intelligence (AI) and Machine Learning (ML) are Reshaping Biotechnology
Exploring the Impact of AI and ML Across the Biotechnology Lifecycle As biotechnology continues to…
iSpeak Blog
ISPE Member Spotlight: Nathan Roman
Nathan Roman is a Director, Industry Advisor, and Global Brand Ambassador with Ellab. He has been an…
Basic page
Events - Save the Dates
ISPE Nordic Affiliate 2025 Upcoming Events Plan Ahead with ISPE Nordic Affiliate Below you will find…
iSpeak Blog
Process Intensification, Continuous Manufacturing, and Sustainability
Biotech companies are meeting modern sustainability objectives and gaining a competitive advantage…
iSpeak Blog
New ISPE Good Practice Guide Helps Pave the Way to Digital Validation
In 2023, the ISPE Commissioning and Qualification (C&Q) Community of Practice (CoP) conducted a…
Video
QRM Based Integrated C&Q Series - Engineering Change Management
QRM Based Integrated C&Q Series - Engineering Change Management Complimentary Learning Level…
Product
Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (Third Edition)
Published: December 2024 Pages: 122 Table of Contents Special Pricing for Emerging Economies This…
iSpeak Blog
Disaster Recovery in the Pharmaceutical Industry: Lessons Learned from Conflict and Catastrophe
In the pharmaceutical industry, disaster recovery is not just about protecting business continuity…
Basic page
AI Is Here. Harness the Potential with ISPE.
Join Today. Use code AI25Bio to purchase your membership and conference pass in one easy step, and…
Product
Good Practice Guide: Digital Validation
Published: April 2025 Pages: 90 Table of Contents Special Pricing for Emerging Economies This Guide…
Video
AI/ML in Regulated Life Sciences (GxP) Sectors – Operation Phase: Maintaining a State of Control
AI/ML in Regulated Life Sciences (GxP) Sectors – Operation Phase: Maintaining a State of Control…
iSpeak Blog
Validation of an Automated Glassware Washer
The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee continues its…
iSpeak Blog
Trends and Opportunities: How Artificial Intelligence (AI) and Machine Learning (ML) are Reshaping Biotechnology
Exploring the Impact of AI and ML Across the Biotechnology Lifecycle As biotechnology continues to…
iSpeak Blog
ISPE Member Spotlight: Nathan Roman
Nathan Roman is a Director, Industry Advisor, and Global Brand Ambassador with Ellab. He has been an…
Basic page
Events - Save the Dates
ISPE Nordic Affiliate 2025 Upcoming Events Plan Ahead with ISPE Nordic Affiliate Below you will find…
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
Apr 24, 2025
Validation
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Apr 08, 2025
Data Integrity
Apr 07, 2025
Advanced Manufacturing
Artificial Intelligence
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Mar 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
iSpeak Blog Posts
Webinars
Upcoming
On-Demand
ISPE in the News
Latest
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ISPE Training: Commissioning and Qualification, Online Live, 5-8 May
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Disaster Recovery in the Pharmaceutical Industry: Lessons Learned from Conflict and Catastrophe
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AI Speeds Drug Discovery, But Human Element Remains Essential
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Ruling Blocks Pharmacies From Making Compounded Semaglutide
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HVAC Equipment Maker Signs US Distribution Deal
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New Single-Use Bioreactor Minimizes Loss
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AbbVie Investing $10B in US Manufacturing
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Merck to Build Keytruda Plant in Delaware
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Nigeria to Invest $5.5B in Pharma Training Institute
- AI to Transform Every Aspect of Biomanufacturing
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