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.
iSpeak Blog
Igniting Innovation in the East: Reflections on ISPE’s Launch in China
A Message from the President and CEO, ISPE A New Chapter for ISPE in China: Reflections from…
PE Articles
Applicability of Vaporized Hydrogen Peroxide for Contamination Control of Lyophilized Biohazards
Controlling contamination in environments where biological medicinal products are handled is of…
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…
PE Articles
Presaturated Wipes: Simple and Powerful Contamination Control
Cleaning surfaces and equipment in controlled environments has historically involved a variety of…
PE Articles
Formulation Challenges in Lyophilized Products
Formulation challenges in pharmaceuticals are increasing in complexity due to the rise of…
iSpeak Blog
Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 1 – Materials and Components
Introduction: Part 1 Cleanroom garments are worn by operators working in certified cleanrooms to…
iSpeak Blog
Sustainability Meets Strategy: Shape the Future of Pharma™ at the 2025 ISPE Annual Meeting & Expo
As the pharmaceutical industry evolves, sustainability is becoming a key driver of operational…
PE Articles
Unlock Operational Excellence: Your Roadmap to Asset Performance Management
In an industry where reliability, compliance, and efficiency are non-negotiable, how mature is your…
Video
Effective Process Validation Strategies for Successful Product Commercialization
Effective Process Validation Strategies for Successful Product Commercialization Complimentary…
PE Articles
Streamline Your Pharma Building Infrastructure with Next-Gen Solutions
In the rapidly evolving pharmaceutical landscape, manufacturers face mounting pressure to deliver…
iSpeak Blog
Balancing Speed and Quality in the Construction of Pharmaceutical Facilities
The pharmaceutical industry is no stranger to innovation. From pioneering drug development to…
PE Articles
Elevating High-Purity Piping: The SYGEF PVDF Advantage
In the world of pharmaceutical and life sciences manufacturing, purity, reliability, and performance…
iSpeak Blog
Igniting Innovation in the East: Reflections on ISPE’s Launch in China
A Message from the President and CEO, ISPE A New Chapter for ISPE in China: Reflections from…
PE Articles
Applicability of Vaporized Hydrogen Peroxide for Contamination Control of Lyophilized Biohazards
Controlling contamination in environments where biological medicinal products are handled is of…
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…
PE Articles
Presaturated Wipes: Simple and Powerful Contamination Control
Cleaning surfaces and equipment in controlled environments has historically involved a variety of…
PE Articles
Formulation Challenges in Lyophilized Products
Formulation challenges in pharmaceuticals are increasing in complexity due to the rise of…
iSpeak Blog
Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 1 – Materials and Components
Introduction: Part 1 Cleanroom garments are worn by operators working in certified cleanrooms to…
iSpeak Blog
Sustainability Meets Strategy: Shape the Future of Pharma™ at the 2025 ISPE Annual Meeting & Expo
As the pharmaceutical industry evolves, sustainability is becoming a key driver of operational…
PE Articles
Unlock Operational Excellence: Your Roadmap to Asset Performance Management
In an industry where reliability, compliance, and efficiency are non-negotiable, how mature is your…
Video
Effective Process Validation Strategies for Successful Product Commercialization
Effective Process Validation Strategies for Successful Product Commercialization Complimentary…
PE Articles
Streamline Your Pharma Building Infrastructure with Next-Gen Solutions
In the rapidly evolving pharmaceutical landscape, manufacturers face mounting pressure to deliver…
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
Jul 08, 2025
Information Systems
Artificial Intelligence
Data Integrity
Jul 08, 2025
Pharma 4.0™
Jun 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Jun 19, 2025
Quality
Lifecycle Management
Validation
May 22, 2025
Apr 24, 2025
Validation
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
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…
Applicability of Vaporized Hydrogen Peroxide for Contamination Control of Lyophilized Biohazards
Controlling contamination in environments where biological medicinal products are handled is of…
Assessing Containment Equipment and Systems with New ISPE Guide
Effective containment systems in a pharmaceutical manufacturing facility are essential to protect…
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…
Applicability of Vaporized Hydrogen Peroxide for Contamination Control of Lyophilized Biohazards
Controlling contamination in environments where biological medicinal products are handled is of…
Assessing Containment Equipment and Systems with New ISPE Guide
Effective containment systems in a pharmaceutical manufacturing facility are essential to protect…
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…
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
Webinars
Upcoming
On-Demand
ISPE in the News
Latest
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ISPE Academy's GMP Refresher Certificate Program
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ISPE Webinar: ISPE Clinical Supply Business Continuity Survey Results and Discussion
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Varda Raises $187M to Manufacture APIs in Space
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US FDA Drafts Aluminum Exposure Guidance for Parenteral Drugs
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Trump Threatens 200% Tariffs on Imported Pharma Products
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EU to Compile List of Critical Medicines for Stockpile
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Phlow Temporarily Halts Production After Roof Catches Fire
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Considerations for Designing Live Biotherapeutic Product Facilities
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Continuous Manufacturing for mAbs May Leave Smaller Environmental Footprint
- US FDA Layoffs Raise Concerns about Foreign Drug Plant Inspections
