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
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…
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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…
Video
Automation Isn’t Automatic: Strategy for Designing and Building a Fully Autonomous Laboratory
Automation Isn’t Automatic: Strategy for Designing and Building a Fully Autonomous Laboratory…
iSpeak Blog
Navigating the PFAS Challenge in Pharma
Per- and polyfluoroalkyl substances (PFAS) have emerged as a major concern in the pharmaceutical…
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 08, 2025
Validation
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
Mar 20, 2025
Mar 20, 2025
iSpeak Blog Posts
Webinars
ISPE in the News
Latest
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Coming Soon and Recently Published ISPE Guidance Documents
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Validation of an Autoclave Cycle
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Polpharma Group Invests in Manufacturing in Kazakhstan
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USP Microbiology Lead on the Importance of Microbial Preservation
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BDD Pharma Opens Facility near Glasgow
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Biomanufacturers Advancing Cell Culture Techniques
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Considerations for Analytical Testing in GMP Settings
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Manufacturers Take Steps to Reduce SUT Waste
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EU Pharma Industry Braces for US Tariffs
- ISPE Webinar: QRM Based Integrated C&Q Series – Good Engineering Practices (GEP) as a Key Enabler for Integrated C&Q
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. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. The course is self-paced. On average, the time required for completion ranges from 1 to 3 hours. Registration Fee Member Nonmember US$0 US$0 Buy Now Return to Online Learning ISPE Membership Benefits Become a member today…
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