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
ISPE Announces New ISPE Affiliate and Chapter Chairs and Co-Chairs
ISPE has announced the new 2024-2025 ISPE Affiliate and Chapter Council Chairs and Co-Chairs. ISPE…
Video
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies
Visual Inspection Defects in Oral Solid Dosage Forms: Effective Troubleshooting Strategies Extended…
iSpeak Blog
Peer Companies Share Knowledge on CMO Asset Management and Obsolescence Management in Recent Asset Management Benchmarking Session
In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified…
iSpeak Blog
Celebrating Excellence: Niranjan Kulkarni, PhD, Recognized as 2024 ISPE Max Seales Yonker Award Recipient
At the 2024 ISPE Annual Meeting & Expo, in Orlando, Florida, this past October, ISPE proudly…
Basic page
Conference Videos
Videos to use in marketing campaigns. ISPE in One Word Download ISPE Membership Join - Fall Drive…
iSpeak Blog
Building Resilience in ATMP Manufacturing: Insights and Innovations at the 2025 ISPE Aseptic Conference
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues, or cells. This…
iSpeak Blog
Honoring Innovation and Leadership: ISPE’s Pharma 4.0™ Baseline Guide Authoring Team Wins the 2024 ISPE International Honor Award for Committee of the Year
ISPE’s Pharma 4.0™ Baseline Guide authoring team received the prestigious Committee of the Year…
iSpeak Blog
Advancing Precision Medicine with ADCs and Radiopharmaceuticals
The pharmaceutical industry is undergoing a remarkable transformation, with advanced modalities like…
iSpeak Blog
EMA Executive Director Discusses the Future of Innovation and Regulation
On 16 October at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, USA, Emer Cooke, European…
PE Articles
Pharma 4.0 – Plug & Produce Architectural Principles
A set of principles to be considered in the journey to adopting and deploying an architecture…
iSpeak Blog
Digital Innovation Conference Debut from ISPE Australasia
In this blog post, Charlie Wakeham, Director of WakeUp to Quality and Chair of the ISPE GAMP® Global…
iSpeak Blog
Pioneering Change: Innovation across Life Science Sustainability and ESG Excellence, Powered and Led by ISPE’s Women in Pharma®
All economic sectors, including life sciences, are undergoing a significant transformation driven by…
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
Dec 20, 2024
Dec 19, 2024
GAMP®
Dec 18, 2024
Dec 16, 2024
Biotechnology
Containment
Dec 11, 2024
Data Integrity
Dec 04, 2024
Good Manufacturing Practice
Dec 04, 2024
GAMP®
Lifecycle Management
iSpeak Blog Posts
Webinars
ISPE in the News
Latest
-
Who Said It? I probably have genius. But no talent.
-
ISPE Announces New ISPE Affiliate and Chapter Chairs and Co-Chairs
-
Agenda Live: 2025 ISPE Europe Annual Conference
-
SmartBrief Holiday Publishing
-
Former US FDA Officials Explain Compounding Rules
-
Hospital in Fiji Builds Drug Manufacturing Plant
-
Novo Nordisk Invests $1.2B in Rare Disease Drug Facility
-
Researchers Optimize TFF for mRNA Purification
-
Meet America's First Pharmaceutical Engineering PhD Grad
- Factors to Consider When Choosing a CDMO for Early-Stage CGT Development
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. Buy Now Return to Online Learning
Featured Conferences