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
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…
Basic page
ISPE Academy
The pharmaceutical industry is a complex and ever-evolving sector that faces numerous challenges…
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…
Basic page
ISPE Academy
The pharmaceutical industry is a complex and ever-evolving sector that faces numerous challenges…
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…
Guidance Documents
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Apr 08, 2025
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Apr 08, 2025
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Apr 07, 2025
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Mar 28, 2025
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Active Pharmaceutical Ingredients
Mar 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Mar 20, 2025
Mar 20, 2025
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ISPE in the News
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ISPE Members: Volunteer with ISPE
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ISPE Webinar: QRM Based Integrated C&Q Series - Engineering Change Management (ECM)
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Belgian Regulators Sharpen ATMP Expertise
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AI Can Streamline Quality Auditing
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Novartis Plans $23B US Investment
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Buffer Recycling Feasible in Downstream Processes
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Automation, AI Could Cut CGT Production Costs
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Experts Present Framework for PAT in Biopharma Manufacturing
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ISPE Delivers ICH Q12 Training to Singapore's Health Authority
- Coming Soon and Recently Published ISPE Guidance Documents
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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