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.
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2025 ISPE FOYA Category Winner for Social Impact Sustainability Excellence
Sanofi Location: Toronto, Canada Project: Wastewater Treatment and Reuse Plant – B99 Sanofi recently…
Basic page
Sponsor FOYA
Previous Slide◀︎ Next Slide▶︎ Year-Round Visibility The Category Winners of the Facility of the Year…
Basic page
The Facility of the Year Awards
ISPE is seeking to recognize projects that demonstrate global leadership by showcasing cutting-edge…
iSpeak Blog
A Regulatory Surveillance and Advocacy Framework
At the 2024 ISPE Annual Meeting & Expo, a session titled “Regulatory Surveillance and Advocacy” was…
iSpeak Blog
Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Digital transformation isn’t a future concept in the biopharmaceutical industry—it is already…
iSpeak Blog
When Analytics Meet Quality
Intersection of Analytical Techniques and Quality Management In today’s data-driven world, the…
iSpeak Blog
Meet Tracy Gu, Vice President of Cockram USA and Champion for ISPE’s Women in Pharma®
Tracy Gu’s first in-person experience with ISPE’s Women in Pharma took place at the 2023 ISPE Annual…
Video
ISPE Tariff Forum
ISPE Tariff Forum Learning Level: Intermediate Session Length: 1.5 hours The ISPE Oral Solid Dosage…
iSpeak Blog
Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
In a world defined by rapid scientific progress and evolving market demands, the ability to adapt…
iSpeak Blog
Pharmaceutical Engineering® Reader Picks for April 2025
Each issue of Pharmaceutical Engineering ® covers a wide range of topics relevant to the…
Basic page
2025 ISPE FOYA Category Winner for Social Impact - Unmet Medical Needs
Bayer Healthcare LLC Location: Berkeley, California, USA Project: Cell Therapy Launch and…
Basic page
2025 ISPE FOYA Category Winner for Pharma 4.0™
CSL Behring Location: Broadmeadows, Victoria, Australia Project: Project Aurora – Facility F Base…
Basic page
2025 ISPE FOYA Category Winner for Social Impact Sustainability Excellence
Sanofi Location: Toronto, Canada Project: Wastewater Treatment and Reuse Plant – B99 Sanofi recently…
Basic page
Sponsor FOYA
Previous Slide◀︎ Next Slide▶︎ Year-Round Visibility The Category Winners of the Facility of the Year…
Basic page
The Facility of the Year Awards
ISPE is seeking to recognize projects that demonstrate global leadership by showcasing cutting-edge…
iSpeak Blog
A Regulatory Surveillance and Advocacy Framework
At the 2024 ISPE Annual Meeting & Expo, a session titled “Regulatory Surveillance and Advocacy” was…
iSpeak Blog
Where Are We on the Digital Road Map? Find Out at the 2025 ISPE Biotechnology Conference
Digital transformation isn’t a future concept in the biopharmaceutical industry—it is already…
iSpeak Blog
When Analytics Meet Quality
Intersection of Analytical Techniques and Quality Management In today’s data-driven world, the…
iSpeak Blog
Meet Tracy Gu, Vice President of Cockram USA and Champion for ISPE’s Women in Pharma®
Tracy Gu’s first in-person experience with ISPE’s Women in Pharma took place at the 2023 ISPE Annual…
Video
ISPE Tariff Forum
ISPE Tariff Forum Learning Level: Intermediate Session Length: 1.5 hours The ISPE Oral Solid Dosage…
iSpeak Blog
Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
In a world defined by rapid scientific progress and evolving market demands, the ability to adapt…
iSpeak Blog
Pharmaceutical Engineering® Reader Picks for April 2025
Each issue of Pharmaceutical Engineering ® covers a wide range of topics relevant to the…
Guidance Documents
Active Pharmaceutical Ingredients (1)
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Community Discussions
Apr 24, 2025
Validation
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
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
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ISPE in the News
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Discover Exciting Career Opportunities on ISPE's Job Board
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ISPE Training: Quality Risk Management, Online Live, 20-22 May
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Tailored Gene Editing Helps Infant with Rare Disease
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New US FDA Commissioner Discusses Priorities
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Merck to Expand Animal Vaccine Capacity
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Sanofi to Invest $20B in US Manufacturing, R&D
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CSL Behring Facility Wins FOYA for Pharma 4.0
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AI Can Aid Characterization of Multispecific Antibodies
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Cockram USA VP Tracy Gu Inspired by Knowledge Sharing in ISPE
- ISPE Training: Aseptic Processing and Annex 1 Training Course, Online Live, 19-22 May
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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