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
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…
Product
ISPE Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (Third Edition)
Published: December 2024 Pages: 122 Table of Contents Special Pricing for Emerging Economies This…
Video
Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
This third edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends…
iSpeak Blog
Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
The 2025 ISPE Europe Annual Conference, taking place 12-14 May in London, United Kingdom, will…
PE Articles
How to Establish a Containment Strategy for Pharma Potent Compounds Manufacturing
The aim of this article is to help understand the main containment principles and to present the…
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…
Product
ISPE Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (Third Edition)
Published: December 2024 Pages: 122 Table of Contents Special Pricing for Emerging Economies This…
Video
Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
This third edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends…
iSpeak Blog
Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
The 2025 ISPE Europe Annual Conference, taking place 12-14 May in London, United Kingdom, will…
PE Articles
How to Establish a Containment Strategy for Pharma Potent Compounds Manufacturing
The aim of this article is to help understand the main containment principles and to present the…
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
Apr 24, 2025
Validation
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Apr 08, 2025
Data Integrity
Apr 07, 2025
Advanced Manufacturing
Artificial Intelligence
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Mar 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
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
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ISPE in the News
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Process Intensification, Continuous Manufacturing, and Sustainability
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- Experts: Prepare for US FDA Review Delays
