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
Futureproofing US Pharma Manufacturing Jobs
The US pharmaceutical manufacturing sector is preparing for continued, significant growth over the…
Video
QRM Based Integrated C&Q Series - New Program Initiation, Objections, Audit Defense
QRM Based Integrated C&Q Series - New Program Initiation, Objections, Audit Defense Complimentary…
Basic page
ISPE Regulatory Digest Q1 2025
ISPE is committed to fostering communications and interactions to advance common interests among the…
iSpeak Blog
The Power of Connection: Building Knowledge, Community, and Impact at ISPE
In the pharmaceutical industry, expertise is essential—but connection is what turns expertise into…
iSpeak Blog
Limitations of Current Digital Validation Tools
The pharmaceutical industry is undergoing a significant transformation, moving away from traditional…
PE Articles
Meet the ISPE Staff: Isabella Stoup
In each issue of Pharmaceutical Engineering ®, we introduce a member of the ISPE staff who provides…
PE Articles
ISPE Regulatory News: ISPE Drug Shortages Initiative
The ISPE Drug Shortages Initiative team was invited to present an overview of ISPE’s body of work in…
PE Articles
ISPE Foundation News: International Women’s Day
Sarah Dubin, recipient of an ISPE Women in Pharma scholarship In honor of International Women’s Day…
PE Articles
Volunteer Profile: Ferdinando E. Aspesi, PhD, Pharmaceutical Engineering® Committee Chair
Ferdinando E. Aspesi, PhD, is a Senior Partner at Bridge Associates International, LLC, New Jersey…
PE Articles
Volunteer Profile: Trish Melton, PhD, Guidance Documents Committee Immediate past Chair
Trish Melton, PhD, has over 30 years of experience in the pharmaceutical industry, working in both…
PE Articles
New Edition of Ozone Sanitization Good Practice Guide
The second edition of the ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water…
Video
QRM Based Integrated C&Q Series - Implementing a Science and Risk Based Approach to Commissioning & Qualification
QRM Based Integrated C&Q Series - Implementing a Science and Risk Based Approach to Commissioning &…
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
Mar 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Mar 20, 2025
Mar 20, 2025
Mar 20, 2025
Data Integrity
Mar 14, 2025
Advanced Manufacturing
Critical Utilities
Feb 16, 2025
Workforce of the Future
iSpeak Blog Posts
Webinars
ISPE in the News
Latest
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Futureproofing US Pharma Manufacturing Jobs
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Approaches to Lifecycle Management and Regulatory Readiness in Advanced Therapies
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NIIMBL Issues Grant for Viral Vector Production Process
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Merck Winds Down Production at Pa. API Plant
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LGM Pharma Invests $6M in Expansion
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Cellares Produces CAR T Cell Therapy Using Automated Platform
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Comparing mAb Manufacturing Strategies
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Hospital, Xcell Collaborate on Automated Cell Therapy Platform
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Facilities of the Future Support Employee Well-being
- ISPE Webinar: Automation Isn't Automatic: Strategy for Designing and Building a Fully Autonomous Laboratory
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
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