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.
Basic page
UNLOCKED: Your Exclusive Pass to ISPE’s Top Conference Sessions
2024 ISPE International Conferences You now have exclusive access to ISPE’s most sought-after…
iSpeak Blog
Validation of an Autoclave Cycle
The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee continues its…
PE Articles
Integrating Environmental Monitoring System Data Into Your Quality Management System
Integrating Environmental Monitoring System (EMS) data into your Quality Management System (QMS) isn…
PE Articles
How to Establish a Containment Strategy for Pharma Potent Compounds Manufacturing
The aim of this article is to help understand the main containment principles and to present the…
Video
Complimentary Member Orientation and Benefits Webinar
Join us for the complimentary ISPE Member Orientation and Benefits webinar to unlock your membership…
Product
ISPE 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…
Video
QRM Based Integrated C&Q Series - Good Engineering Practices as a Key Enabler for Integrated C&Q
QRM Based Integrated C&Q Series - Good Engineering Practices as a Key Enabler for Integrated C&Q…
Video
Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
This third edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends…
iSpeak Blog
ISPE Members Continue Training Health Authorities on ICH Q12 Implementation
ISPE’s Q12 Implementation team, a working group under the auspices of ISPE's Product Quality…
Video
Navigating the PFAS Challenge in Pharma: Regulatory Landscape, Risk Management, and Health Implications
Complimentary Learning Level: Intermediate Session Length: 1 hour Per- and polyfluoroalkyl…
iSpeak Blog
Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
The 2025 ISPE Europe Annual Conference, taking place 12-14 May in London, United Kingdom, will…
Basic page
UNLOCKED: Your Exclusive Pass to ISPE’s Top Conference Sessions
2024 ISPE International Conferences You now have exclusive access to ISPE’s most sought-after…
iSpeak Blog
Validation of an Autoclave Cycle
The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee continues its…
PE Articles
Integrating Environmental Monitoring System Data Into Your Quality Management System
Integrating Environmental Monitoring System (EMS) data into your Quality Management System (QMS) isn…
PE Articles
How to Establish a Containment Strategy for Pharma Potent Compounds Manufacturing
The aim of this article is to help understand the main containment principles and to present the…
Video
Complimentary Member Orientation and Benefits Webinar
Join us for the complimentary ISPE Member Orientation and Benefits webinar to unlock your membership…
Product
ISPE 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…
Video
QRM Based Integrated C&Q Series - Good Engineering Practices as a Key Enabler for Integrated C&Q
QRM Based Integrated C&Q Series - Good Engineering Practices as a Key Enabler for Integrated C&Q…
Video
Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
This third edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends…
iSpeak Blog
ISPE Members Continue Training Health Authorities on ICH Q12 Implementation
ISPE’s Q12 Implementation team, a working group under the auspices of ISPE's Product Quality…
Video
Navigating the PFAS Challenge in Pharma: Regulatory Landscape, Risk Management, and Health Implications
Complimentary Learning Level: Intermediate Session Length: 1 hour Per- and polyfluoroalkyl…
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
-
ISPE Member Spotlight: Nathan Roman
-
ISPE Training: GAMP® Basic Principles (2 Days), In Person, 15-16 May
-
High-level US FDA Inspection Official Resigns
-
Oncologist to Lead US FDA's CBER
-
EMA Issues AI Workplan
-
US Orders Freeze-Dried Mpox Vaccine Doses
-
US FDA Rolls Out AI Agency-wide
-
Intertek Expands GMP Facility in England
-
Consortium Develops Automated E. coli Production Process
- How to Prevent Human Error in Pharma Manufacturing
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