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.
PE Articles
FDA’s 2011 Process Validation Guidance: 10 Years On
In 2011, the US Food and Drug Administration (FDA) introduced the revised “Guidance for Industry…
iSpeak Blog
Women in Pharma® Member Spotlight on Miriam Kremer-van der Kamp
Miriam Kremer-van der Kamp is the Business Developer at VILS Switzerland GmbH and an active ISPE…
iSpeak Blog
Pharma 4.0™ and Annex 1 – The Perfect Fit
What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to…
PE Articles
ISPE Global Pharmaceutical Innovation Survey Findings: A Review
In 2023, ISPE launched an expansive and significant initiative, Enabling Global Pharmaceutical…
iSpeak Blog
FDA on AI in Pharmaceutical Manufacturing
At the 2024 ISPE Biotechnology Conference, held in Boston, Massachusetts, USA, in June, Sharmista…
Video
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
Video
Complimentary Member Orientation and Benefits Webinar
Complimentary Member Orientation and Benefits Webinar Complimentary Learning Level: Basic Session…
iSpeak Blog
Join the Global Movement: Mentor ISPE’s Year Three
ISPE Women in Pharma ®’s dedication to diversity, equity, and Inclusion isn't just about aspirations…
iSpeak Blog
Unlock New Insights and Innovations: Explore the 2024 ISPE Annual Meeting & Expo Education Tracks
The 2024 ISPE Annual Meeting & Expo is the pharmaceutical industry’s gateway to discovering the…
PE Articles
Guiding Principles for Combination Product Reliability
Drug delivery devices have become an essential component for many modern medical therapies, and it’s…
PE Articles
Finding the Assurance in Computer Software Assurance
Computer software assurance (CSA) has been discussed widely in industry over the past five years…
PE Articles
Potency Measurements for Cellular and Gene Therapy Products
Cell and gene therapy (C>) products address various diseases at the cellular or genetic level…
PE Articles
FDA’s 2011 Process Validation Guidance: 10 Years On
In 2011, the US Food and Drug Administration (FDA) introduced the revised “Guidance for Industry…
iSpeak Blog
Women in Pharma® Member Spotlight on Miriam Kremer-van der Kamp
Miriam Kremer-van der Kamp is the Business Developer at VILS Switzerland GmbH and an active ISPE…
iSpeak Blog
Pharma 4.0™ and Annex 1 – The Perfect Fit
What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to…
PE Articles
ISPE Global Pharmaceutical Innovation Survey Findings: A Review
In 2023, ISPE launched an expansive and significant initiative, Enabling Global Pharmaceutical…
iSpeak Blog
FDA on AI in Pharmaceutical Manufacturing
At the 2024 ISPE Biotechnology Conference, held in Boston, Massachusetts, USA, in June, Sharmista…
Video
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
Video
Complimentary Member Orientation and Benefits Webinar
Complimentary Member Orientation and Benefits Webinar Complimentary Learning Level: Basic Session…
iSpeak Blog
Join the Global Movement: Mentor ISPE’s Year Three
ISPE Women in Pharma ®’s dedication to diversity, equity, and Inclusion isn't just about aspirations…
iSpeak Blog
Unlock New Insights and Innovations: Explore the 2024 ISPE Annual Meeting & Expo Education Tracks
The 2024 ISPE Annual Meeting & Expo is the pharmaceutical industry’s gateway to discovering the…
PE Articles
Guiding Principles for Combination Product Reliability
Drug delivery devices have become an essential component for many modern medical therapies, and it’s…
Guidance Documents
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Apr 02, 2025
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Mar 28, 2025
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Mar 20, 2025
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Mar 20, 2025
Mar 20, 2025
Mar 20, 2025
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ISPE in the News
Latest
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ISPE Training: Process Validation Training Course, 8 - 10 April
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Discover Exciting Career Opportunities on ISPE's Job Board
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Steele Appointed Acting Director of US FDA's CBER
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US FDA to Cut Back on Routine Inspections
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Tariff Threats Create Uncertainty in Pharma Market
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Expecting the Unexpected Ensures Continuity in Biopharma Manufacturing
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Digital Twin may Streamline Gene Therapy Production
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AMT Designation Granted to Cellares' Cell Shuttle
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Innovative Culture Media Support Intensified Processes
- Navigating Category 3 Compounding Challenges
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, business continuity planning is a powerful…
Operational Risk Management in Global Supply Scenarios
The current regulatory framework in the pharmaceutical industry places pressure on marketing…
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, business continuity planning is a powerful…
Operational Risk Management in Global Supply Scenarios
The current regulatory framework in the pharmaceutical industry places pressure on marketing…
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…
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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