Content focuses on process equipment, the design of facilities, and utility systems that support the critical physical and chemical requirements of drug products, in addition to other aspects of the product specification. Topics include design and construction/installation, commissioning and qualification, operation and maintenance, controls, and automation.
PE Articles
Embracing the Human Side of Manufacturing
For companies focused on producing lifesaving treatments, the positive effects of employee health…
iSpeak Blog
Announcing Pharma 4.0™ and Digitalization Transformation Track at the 2025 ISPE Europe Annual Conference in London, United Kingdom
The future of the pharmaceutical industry is being shaped by rapid advancements in digital…
PE Articles
Ensure Safe Chemical Transport with GF’s Double Containment Systems
Engineered for critical applications, GF Piping Systems’ advanced double containment solutions…
iSpeak Blog
From the Sidelines to the Field: Career Growth Through Industry Engagement
Imagine your favorite sports team. Maybe it’s a football club with a rich history, a devoted fan…
iSpeak Blog
ISPE Members: Optimize Your Membership Experience with ISPE Engage
Unlock the Power of ISPE Engage: Your Essential Networking and Technical Hub As an ISPE member, one…
iSpeak Blog
Technology and Innovation: The Spirit of Discovery
Space Exploration and Pharmaceutical Science: An Unlikely Pairing? Many years ago, during my high…
iSpeak Blog
GAMP® at the 2025 ISPE Europe Annual Conference: Where Quality, AI and Compliance Meet
In today’s rapidly evolving pharmaceutical landscape, advancing technologies, shifting regulatory…
iSpeak Blog
The Power of Connection: Building Knowledge, Community, and Impact at ISPE
In the pharmaceutical industry, expertise is essential—but connection is what turns expertise into…
PE Articles
New Edition of Ozone Sanitization Good Practice Guide
The second edition of the ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water…
PE Articles
Process Architecture and Integrated Design in the Pharmaceutical Sector
Large engineering companies specializing in the industrial production sector have increasingly been…
PE Articles
Using Isolators and Bio-Decontamination to Future-Proof CGT Processes and Facilities
The production of Advanced Therapy Medicinal Products (ATMPs) can have many complex manual steps…
PE Articles
The Power of Fleet Management in Distributed Manufacturing
The pharmaceutical industry faces significant challenges in rapidly expanding production capacity to…
PE Articles
Embracing the Human Side of Manufacturing
For companies focused on producing lifesaving treatments, the positive effects of employee health…
iSpeak Blog
Announcing Pharma 4.0™ and Digitalization Transformation Track at the 2025 ISPE Europe Annual Conference in London, United Kingdom
The future of the pharmaceutical industry is being shaped by rapid advancements in digital…
PE Articles
Ensure Safe Chemical Transport with GF’s Double Containment Systems
Engineered for critical applications, GF Piping Systems’ advanced double containment solutions…
iSpeak Blog
From the Sidelines to the Field: Career Growth Through Industry Engagement
Imagine your favorite sports team. Maybe it’s a football club with a rich history, a devoted fan…
iSpeak Blog
ISPE Members: Optimize Your Membership Experience with ISPE Engage
Unlock the Power of ISPE Engage: Your Essential Networking and Technical Hub As an ISPE member, one…
iSpeak Blog
Technology and Innovation: The Spirit of Discovery
Space Exploration and Pharmaceutical Science: An Unlikely Pairing? Many years ago, during my high…
iSpeak Blog
GAMP® at the 2025 ISPE Europe Annual Conference: Where Quality, AI and Compliance Meet
In today’s rapidly evolving pharmaceutical landscape, advancing technologies, shifting regulatory…
iSpeak Blog
The Power of Connection: Building Knowledge, Community, and Impact at ISPE
In the pharmaceutical industry, expertise is essential—but connection is what turns expertise into…
PE Articles
New Edition of Ozone Sanitization Good Practice Guide
The second edition of the ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water…
PE Articles
Process Architecture and Integrated Design in the Pharmaceutical Sector
Large engineering companies specializing in the industrial production sector have increasingly been…
Guidance Documents
Advanced Manufacturing (3)
+Advanced Therapy Medicinal Products (1)
+Biotechnology (3)
+Commissioning & Qualification (5)
+Compounding (2)
+Containment (4)
+Critical Utilities (7)
+Data Integrity (2)
+GAMP® (1)
+Good Manufacturing Practice (1)
+Manufacturing Operations (9)
+Microbiological & Viral Contamination Control (15)
+Oral Solid Dosage (2)
+Packaging (2)
+Pharma 4.0™ (1)
+Quality Assurance (1)
+Quality Control (2)
+Quality by Design (2)
+Regulatory (5)
+Single Use Technologies & Disposables (1)
+Sterile Products (2)
+Supply Chain Management (2)
+Sustainability (1)
+Sustainable Facilities, HVAC, & Controlled Environments (6)
+Validation (1)
+Community Discussions
Community Discussions
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Mar 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Mar 20, 2025
Mar 20, 2025
Mar 20, 2025
Data Integrity
Mar 14, 2025
Advanced Manufacturing
Critical Utilities
White Papers
July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
July / August 2023
Continuous manufacturing (CM) challenged regulators’ expectations and regulatory frameworks. This…
May / June 2023
North Carolina’s Research Triangle is the largest of its kind in the US. Thanks to years of effort…
May / June 2022
Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to…
Pharmaceutical Engineering Magazine Articles
Your Professional Development at the Facilities of the Future Conference
The 2025 ISPE Facilities of the Future (FoF) Conference will be held 27–28 January in San Francisco…
The Need for a New HVAC Good Practice Guide
Since its original publication in 2009, the ISPE Good Practice Guide: Heating, Ventilation and Air…
ISPE Announces the 2024 Facility of the Year Award Winner
At the 2024 Facility of the Year Award (FOYA) Celebratory Banquet, ISPE announced the 2024 overall…
Net-Zero Manufacturing Facilities: Obstacles and Benefits
The decision to pursue net-zero facility design in manufacturing is complicated. There are…
FOYA Projects Embrace Innovative Sustainability Solutions
Established in 2004, the Facility of the Year Awards (FOYA) recognize state-of-the-art projects…
New Edition of Ozone Sanitization Good Practice Guide
The second edition of the ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water…
Process Architecture and Integrated Design in the Pharmaceutical Sector
Large engineering companies specializing in the industrial production sector have increasingly been…
Using Isolators and Bio-Decontamination to Future-Proof CGT Processes and Facilities
The production of Advanced Therapy Medicinal Products (ATMPs) can have many complex manual steps…
The Power of Fleet Management in Distributed Manufacturing
The pharmaceutical industry faces significant challenges in rapidly expanding production capacity to…
Embracing the Human Side of Manufacturing
For companies focused on producing lifesaving treatments, the positive effects of employee health…
Reevaluating Transfer of RTU Containers Into Grade A
At first glance, ready-to-use (RTU) primary packaging material (tub systems) give production lines…
Aseptic Conference Focuses on Technical and Regulatory Issues
The 2025 ISPE Aseptic Conference will be held 17–18 March in Washington, DC, and virtually. Christa…
Your Professional Development at the Facilities of the Future Conference
The 2025 ISPE Facilities of the Future (FoF) Conference will be held 27–28 January in San Francisco…
The Need for a New HVAC Good Practice Guide
Since its original publication in 2009, the ISPE Good Practice Guide: Heating, Ventilation and Air…
ISPE Announces the 2024 Facility of the Year Award Winner
At the 2024 Facility of the Year Award (FOYA) Celebratory Banquet, ISPE announced the 2024 overall…
Net-Zero Manufacturing Facilities: Obstacles and Benefits
The decision to pursue net-zero facility design in manufacturing is complicated. There are…
FOYA Projects Embrace Innovative Sustainability Solutions
Established in 2004, the Facility of the Year Awards (FOYA) recognize state-of-the-art projects…
New Edition of Ozone Sanitization Good Practice Guide
The second edition of the ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water…
Process Architecture and Integrated Design in the Pharmaceutical Sector
Large engineering companies specializing in the industrial production sector have increasingly been…
Using Isolators and Bio-Decontamination to Future-Proof CGT Processes and Facilities
The production of Advanced Therapy Medicinal Products (ATMPs) can have many complex manual steps…
The Power of Fleet Management in Distributed Manufacturing
The pharmaceutical industry faces significant challenges in rapidly expanding production capacity to…
Embracing the Human Side of Manufacturing
For companies focused on producing lifesaving treatments, the positive effects of employee health…
Professional Development Training
Good Engineering Practice (GEP) Training Course
+GMP Fundamentals: Eleven-Part Bundle Series
+Biopharmaceuticals: Webinar C> e ATMP
+Produtos Biofarmacêuticos: Aspectos CMC
+GMP Fundamentals: Packaging & Labeling Control
+Pharmaceutical Job Board
Videos
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ISPE in the News
Latest
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Coming Soon and Recently Published ISPE Guidance Documents
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Pharmaceutical Compounding: A US FDA Perspective
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Mexico to Recognize GMP Certifications from North, South American Authorities
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UK Launches Monthly Bulletins on Device, Drug Safety
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Inside Africa's Plan to Produce Vaccines Locally
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Pharma Companies Developing Protein Interaction Prediction Model
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CDMO Building 2nd Manufacturing Facility in Portugal
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Flexible Robot can Automate Medical Device Manufacturing
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New Method May Improve CHO Efficiency
- How Digital Shadows Can Enhance Downstream Processing
