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.
News
The International Society for Pharmaceutical Engineering Announces New Certificate Programs
ISPE has announced new certificate programs from ISPE Academy: Biopharmaceutical Essentials and Good…
iSpeak Blog
Meet the 2025 ISPE Facility of the Year Awards (FOYA) Category Winner for Pharma 4.0™
CSL Behring – Project Aurora – Plasma Base Fractionation Facility (Facility F) CSL is an Australian…
Video
2025 ISPE FOYA Category Winner for Pharma 4.0 - CSL Behring
CSL Project Aurora is a significant base fractionation expansion initiative at the Broadmeadows…
Video
2025 ISPE FOYA Category Winner for Social Impact Sustainability Excellence - Sanofi
The Wastewater Treatment and Recovery Plant (WWTRP) exemplifies Sanofi's dedication to…
Video
Validation in Transition: 2025’s Top Trends, Tools, and Takeaways
Validation in Transition: 2025’s Top Trends, Tools, and Takeaways Sponsored Learning Level…
Video
Improving Productivity and Reducing COGS in Bioprocesses Using Capacitance as a PAT Tool
Improving Productivity and Reducing COGS in Bioprocesses Using Capacitance as a PAT Tool…
iSpeak Blog
Navigating Global Oversight USFDA Update: 2025 ISPE China Conference in Shanghai
At the 2025 ISPE China Conference in Shanghai, China in May 2025, Marcus Ray, Medical Products…
iSpeak Blog
Shaping Tomorrow's Pharmaceutical Framework: Embracing Digital Transformation and Technology in an Evolving Landscape
Regulators from the European Medicines Agency (EMA), the United Kingdom’s (UK) Medicines and…
iSpeak Blog
Learn About the Future of USP Plastics in Biotech
The United States Pharmacopeia (USP) has long set standards for the use of plastics in medical…
News
ISPE Announces Six 2025 FOYA Category Winners
The ISPE Facility of the Year Awards (FOYA) program, which celebrates its 20th anniversary this year…
iSpeak Blog
Navigating through Advanced Therapy Medicinal Products (ATMPs) Guidance and Regulations
It is not surprising that there are regulations and guidance specifically for ATMPs. However, it may…
iSpeak Blog
New GAMP®Guide Provides Framework to Acheive High-Quality AI-Enabled Computerized Systems for Life Sciences
A strategic goal of the new ISPE GAMP ® Guide: Artificial Intelligence is to establish the overall…
News
The International Society for Pharmaceutical Engineering Announces New Certificate Programs
ISPE has announced new certificate programs from ISPE Academy: Biopharmaceutical Essentials and Good…
iSpeak Blog
Meet the 2025 ISPE Facility of the Year Awards (FOYA) Category Winner for Pharma 4.0™
CSL Behring – Project Aurora – Plasma Base Fractionation Facility (Facility F) CSL is an Australian…
Video
2025 ISPE FOYA Category Winner for Pharma 4.0 - CSL Behring
CSL Project Aurora is a significant base fractionation expansion initiative at the Broadmeadows…
Video
2025 ISPE FOYA Category Winner for Social Impact Sustainability Excellence - Sanofi
The Wastewater Treatment and Recovery Plant (WWTRP) exemplifies Sanofi's dedication to…
Video
Validation in Transition: 2025’s Top Trends, Tools, and Takeaways
Validation in Transition: 2025’s Top Trends, Tools, and Takeaways Sponsored Learning Level…
Video
Improving Productivity and Reducing COGS in Bioprocesses Using Capacitance as a PAT Tool
Improving Productivity and Reducing COGS in Bioprocesses Using Capacitance as a PAT Tool…
iSpeak Blog
Navigating Global Oversight USFDA Update: 2025 ISPE China Conference in Shanghai
At the 2025 ISPE China Conference in Shanghai, China in May 2025, Marcus Ray, Medical Products…
iSpeak Blog
Shaping Tomorrow's Pharmaceutical Framework: Embracing Digital Transformation and Technology in an Evolving Landscape
Regulators from the European Medicines Agency (EMA), the United Kingdom’s (UK) Medicines and…
iSpeak Blog
Learn About the Future of USP Plastics in Biotech
The United States Pharmacopeia (USP) has long set standards for the use of plastics in medical…
News
ISPE Announces Six 2025 FOYA Category Winners
The ISPE Facility of the Year Awards (FOYA) program, which celebrates its 20th anniversary this year…
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Guidance Documents
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Jul 25, 2025
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Jul 24, 2025
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Jul 17, 2025
Manufacturing Operations
Oral Solid Dosage
Jul 08, 2025
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Message from the Chair: How ISPE Is Empowering Pharma's AI Evolution
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ISPE Training: Cleaning Validation Principles, Online Live, 8-11 September
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Texas Company Makes Facial Implants for Use in Ukraine
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Startup Produces Animal-Free Protein for Cell Culture Media
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CSL Cuts Jobs, Plans to Spin Off Vaccine Unit
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CDMO Expands Sterile Fill-Finish Facility in Fla.
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WuXi Biologics' FOYA-Winning Site in Ireland to Produce Innovative Biologic
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A Risk-Based Framework for HPAPI Synthesis
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Prepare Now for US FDA QMM Program and Reap Benefits Later
- Driving Better Outcomes for Quality Control Labs
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
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