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
A Visit to 中外製薬工業株式会社 Chugai’s Award-Winning Tokyo Facility: A Benchmark in Social Impact and Excellence
A Message from the President and CEO, ISPE - In late May, I had the distinct pleasure of visiting…
PE Articles
Desiccant Dehumidification Future-Proofs Pharma Production
Environmental control plays a critical role in pharmaceutical manufacturing, particularly when it…
PE Articles
ABM Clean Room Solutions for Life Science Companies
ABM uses advanced technology and precise tracking to ensure cleanroom compliance, prevent…
PE Articles
Formulation Challenges in Lyophilized Products
Formulation challenges in pharmaceuticals are increasing in complexity due to the rise of…
PE Articles
Presaturated Wipes: Simple and Powerful Contamination Control
Cleaning surfaces and equipment in controlled environments has historically involved a variety of…
iSpeak Blog
Workforce of the Future – Challenges and Opportunities
Reflections from the Recent 2025 ISPE Europe Annual Conference Session Powered and Led by ISPE’s…
Basic page
International Board of Directors Election
ISPE International Board of Directors Election Process The ISPE International Board of Directors…
iSpeak Blog
Regulatory Innovation and Global Collaboration highlighted at the ISPE Europe Annual Conference
Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the Future of Global Good Manufacturing…
iSpeak Blog
Unlocking the Future of Pharma: Mentor ISPE Launches Expert Webinar Series with a Deep Dive into Machine Learning (ML)/Artificial Intelligence (AI) Case Studies
Mentor ISPE, powered and led by Women in Pharma ®, is leveling up in 2025 with a powerful new…
iSpeak Blog
EMA Support for Innovation in Pharmaceutical Manufacturing
At the 2025 ISPE Europe Annual Conference held 12-14 May 2025 in London, the European Medicines…
Video
QRM Based Integrated C&Q Series - User Requirement Specification
QRM Based Integrated C&Q Series - User Requirement Specification Complimentary Learning Level…
iSpeak Blog
Driving Excellence in Pharma: Explore the Manufacturing, Quality Control, and Operational Excellence Track at the 2025 ISPE Annual Meeting & Expo
Pharmaceutical manufacturers are always under pressure to move faster, stay compliant, and deliver…
iSpeak Blog
A Visit to 中外製薬工業株式会社 Chugai’s Award-Winning Tokyo Facility: A Benchmark in Social Impact and Excellence
A Message from the President and CEO, ISPE - In late May, I had the distinct pleasure of visiting…
PE Articles
Desiccant Dehumidification Future-Proofs Pharma Production
Environmental control plays a critical role in pharmaceutical manufacturing, particularly when it…
PE Articles
ABM Clean Room Solutions for Life Science Companies
ABM uses advanced technology and precise tracking to ensure cleanroom compliance, prevent…
PE Articles
Formulation Challenges in Lyophilized Products
Formulation challenges in pharmaceuticals are increasing in complexity due to the rise of…
PE Articles
Presaturated Wipes: Simple and Powerful Contamination Control
Cleaning surfaces and equipment in controlled environments has historically involved a variety of…
iSpeak Blog
Workforce of the Future – Challenges and Opportunities
Reflections from the Recent 2025 ISPE Europe Annual Conference Session Powered and Led by ISPE’s…
Basic page
International Board of Directors Election
ISPE International Board of Directors Election Process The ISPE International Board of Directors…
iSpeak Blog
Regulatory Innovation and Global Collaboration highlighted at the ISPE Europe Annual Conference
Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the Future of Global Good Manufacturing…
iSpeak Blog
Unlocking the Future of Pharma: Mentor ISPE Launches Expert Webinar Series with a Deep Dive into Machine Learning (ML)/Artificial Intelligence (AI) Case Studies
Mentor ISPE, powered and led by Women in Pharma ®, is leveling up in 2025 with a powerful new…
iSpeak Blog
EMA Support for Innovation in Pharmaceutical Manufacturing
At the 2025 ISPE Europe Annual Conference held 12-14 May 2025 in London, the European Medicines…
Guidance Documents
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+Packaging (1)
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+Sustainable Facilities, HVAC, & Controlled Environments (1)
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Community Discussions
Jun 06, 2025
Sustainable Facilities, HVAC, & Controlled Environments
May 22, 2025
Apr 24, 2025
Validation
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Apr 08, 2025
Data Integrity
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ISPE in the News
Latest
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Meet Tracy Gu, Vice President of Cockram USA and Champion for ISPE's Women in Pharma®
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ISPE Podcast Episode: ISPE's Role in Advancing Pharmaceutical Manufacturing
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Quantoom to Use TriLink's mRNA Capping Technology
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UK MHRA Releases Guidance on Phage Therapies
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EMA Proposes Streamlined Biosimilar Approval Pathway
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Tracelink CEO: AI Transforming Pharma Supply Chain
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USP Opens Maryland Lab to Boost Drug Production
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Sanofi to Invest $20B in US Manufacturing, R&D
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Continuous Flow IVT Transforms RNA Manufacturing
- Experts Share Best Practices for Fill-Finish Operations
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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