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
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…
iSpeak Blog
Navigating the PFAS Challenge in Pharma
Per- and polyfluoroalkyl substances (PFAS) have emerged as a major concern in the pharmaceutical…
iSpeak Blog
Data Management Requirements for Sterile Manufacturing
Ronald Bauer, PhD and Christina Meissner, PhD from the Austrian Agency for Health and Food Safety…
iSpeak Blog
Technology and Innovation: The Spirit of Discovery
Space Exploration and Pharmaceutical Science: An Unlikely Pairing? Many years ago, during my high…
iSpeak Blog
GAMP® at the 2025 ISPE Europe Annual Conference: Where Quality, AI and Compliance Meet
In today’s rapidly evolving pharmaceutical landscape, advancing technologies, shifting regulatory…
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…
iSpeak Blog
Navigating the PFAS Challenge in Pharma
Per- and polyfluoroalkyl substances (PFAS) have emerged as a major concern in the pharmaceutical…
iSpeak Blog
Data Management Requirements for Sterile Manufacturing
Ronald Bauer, PhD and Christina Meissner, PhD from the Austrian Agency for Health and Food Safety…
iSpeak Blog
Technology and Innovation: The Spirit of Discovery
Space Exploration and Pharmaceutical Science: An Unlikely Pairing? Many years ago, during my high…
iSpeak Blog
GAMP® at the 2025 ISPE Europe Annual Conference: Where Quality, AI and Compliance Meet
In today’s rapidly evolving pharmaceutical landscape, advancing technologies, shifting regulatory…
iSpeak Blog
Futureproofing US Pharma Manufacturing Jobs
The US pharmaceutical manufacturing sector is preparing for continued, significant growth over the…
Guidance Documents
Active Pharmaceutical Ingredients (1)
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+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)
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Mar 14, 2025
Advanced Manufacturing
Critical Utilities
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ISPE in the News
Latest
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Coming Soon and Recently Published ISPE Guidance Documents
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Pharmaceutical Compounding: A US FDA Perspective
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Mexico to Recognize GMP Certifications from North, South American Authorities
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UK Launches Monthly Bulletins on Device, Drug Safety
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Inside Africa's Plan to Produce Vaccines Locally
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Pharma Companies Developing Protein Interaction Prediction Model
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CDMO Building 2nd Manufacturing Facility in Portugal
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Flexible Robot can Automate Medical Device Manufacturing
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New Method May Improve CHO Efficiency
- How Digital Shadows Can Enhance Downstream Processing
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…
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GMP Fundamentals: Holding & Distribution
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