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
Inside Takeda’s 2026 ISPE Facility of the Year Awards (FOYA) Social Impact Category Award-Winning Sustainability Project
As the pharmaceutical industry works to reduce its environmental footprint while continuing to…
iSpeak Blog
Modernizing Turnover Package Reviews in Pharmaceutical Projects: A Step Towards Digital Project Delivery
Turnover package (TOP) is one of the most critical deliverables in pharmaceutical projects. It…
Video
2026 Facility of the Year Awards (FOYA) Category Winner for Innovation - Sanofi
The vision for Modulus was shaped through an extensive and strategic concept development phase…
iSpeak Blog
Inside Bayer AG's 2026 ISPE FOYA Category Award-Winning Project for Operations Excellence and Pharma 4.0™
Bayer AG’s SOLIDA-1 facility in Leverkusen, Germany, has achieved a rare distinction in the…
Video
Takeda - 2026 ISPE FOYA Category Winner for Social Impact – Sustainability Efforts
Project AHEAD supports Takeda's net-zero goals for 2035 (operations) and 2040 (value chain). Its…
PE Articles
Strengthening Quality and Supply with Effective Risk Management
The new ISPE Guide: Quality Risk Management provides practical direction on applying QRM principles…
Video
Vaccines Manufacturing Air Change Rate Reduction with Integrated Risk-Based Execution
Vaccines Manufacturing Air Change Rate Reduction with Integrated Risk-Based Execution Complimentary…
iSpeak Blog
Designing Viral Vector Facilities: Key Issues to Consider
Adeno-associated virus (AAV) therapeutics have been in production for more than a decade, and the…
Video
FOYA Social Impact – Unmet Medical Needs: AstraZeneca – Commercial Cell Therapy Facility
The AstraZeneca Commercial Cell Therapy Facility in Rockville, Maryland, is a 105,000 square foot…
iSpeak Blog
The Step That Keeps Being Skipped and Why It's Costing Us
Let's be honest: too many pharmaceutical projects in Europe and abroad, move from a business need, a…
Video
FOYA Honorable Mention: Chugai Pharma Manufacturing - FJ3 Project
The 2026 ISPE FOYA Honorable Mention recognizes the FJ3 Project at Chugai Pharma Manufacturing's…
Video
Redesigning Cleaning Validation: From Compliance to Value
Redesigning Cleaning Validation: From Compliance to Value Complimentary Learning Level: Intermediate…
Guidance Documents
Advanced Manufacturing (4)
Advanced Therapy Medicinal Products (2)
Biotechnology (3)
Commissioning & Qualification (5)
- ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems (Third Edition)
- ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (Second Edition)
- Good Practice Guide: Decommissioning Pharma Equipment & Facilities
- Good Practice Guide: Controlled Temperature Chambers 2nd Edition
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
Compounding (2)
Containment (4)
- ISPE Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (Third Edition)
- Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
- Good Practice Guide: Containment for Potent Compounds
- Good Practice Guide: Asset Management
Critical Utilities (6)
- ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems (Third Edition)
- Good Practice Guide: Process Gases 2nd Edition
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Good Practice Guide: Membrane-Based WFI Systems
- Good Practice Guide: Critical Utilities GMP Compliance
- D/A/CH Affiliate: WFI Handbook (English Translation)
Data Integrity (2)
Facilities of the Future (1)
Good Manufacturing Practice (1)
Knowledge Management (1)
Lifecycle Management (1)
Manufacturing Operations (10)
- ISPE Guide: Sustainability
- ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems (Second Edition)
- Guide: ATMPs - Allogeneic Cell Therapy
- Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition
- Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
- Guide: ATMPs - Autologous Cell Therapy
- GAMP Good Practice Guide: Manufacturing Execution Systems
- Good Practice Guide: Maintenance 2nd Edition
- Good Practice Guide: Equipment Reliability
- Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
Microbiological & Viral Contamination Control (14)
- ISPE Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (Third Edition)
- ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems (Second Edition)
- Good Practice Guide: Process Gases 2nd Edition
- Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls
- Good Practice Guide: Quality Lab Facilities
- Good Practice Guide: Membrane-Based WFI Systems
- Good Practice Guide: Containment for Potent Compounds
- D/A/CH Affiliate: WFI Handbook (English Translation)
- Good Practice Guide: HVAC & Process Equipment Air Filters
- Good Practice Guide: Asset Management
- Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
- Japan Affiliate: Pest Control Manual (English Translation)
Oral Solid Dosage (2)
Packaging (2)
Pharma 4.0™ (1)
Process Analytical Technology (1)
Quality Assurance (1)
Quality Control (1)
Quality by Design (3)
Regulatory (5)
- ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems (Second Edition)
- ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (Second Edition)
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Good Practice Guide: Critical Utilities GMP Compliance
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
Single Use Technologies & Disposables (1)
Sterile Products (3)
Supply Chain Management (2)
Sustainability (2)
Sustainable Facilities, HVAC, & Controlled Environments (6)
- ISPE Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (Third Edition)
- ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (Second Edition)
- Good Practice Guide: Cold Chain Management
- Good Practice Guide: Containment for Potent Compounds
- Good Practice Guide: Controlled Temperature Chambers 2nd Edition
- Good Practice Guide: HVAC & Process Equipment Air Filters
Community Discussions
Community Discussions
Mar 18, 2026
Data Integrity
Mar 12, 2026
Mar 11, 2026
Data Integrity
Mar 11, 2026
Advanced Therapy Medicinal Products
Biotechnology
Mar 05, 2026
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
Strengthening Quality and Supply with Effective Risk Management
The new ISPE Guide: Quality Risk Management provides practical direction on applying QRM principles…
Sustainability Challenges of Single-Use Technologies
The promise of single-use technologies (SUTs) in biopharmaceutical manufacturing is as compelling as…
ISPE Announces 2026 Facility of the Year Awards Category Winners
ISPE’s FOYA program recognizes state-of-the-art projects using innovative technologies to improve…
Mold Risk in Cleanrooms: A Holistic Control Approach
Mold contamination is one of the most persistent threats to cleanroom integrity in pharmaceutical…
New Good Practice Guide: ATMPs – Equipment Design and Qualification for Cellular Therapy Manufacturing
The rapid rise of cellular therapies is transforming modern medicine and creating new challenges for…
Pharmaceutical Cleanroom Design Transformation Using CFD and BIM
As facilities become more complex and equipment requirements more demanding, engineers face…
Lyophilizer Shelf Temperature Mapping: Part II: Study Design
Qualification of equipment used in the manufacturing of pharmaceutical products is a critical step…
ISPE Facilities of the Future Conference
The 2026 ISPE Facilities of the Future (FOF) Conference will be held 2–3 February in San Diego…
Key Factors Involved in Designing Specialized Manufacturing Facilities for Cell-Based ATMPs: Layout, HVAC Requirements and Area Classification
The rapid advancement of Advanced Therapy Medicinal Products (ATMPs) has revolutionized healthcare…
Risk-Based Containment Strategy: A Case Study for a Synthetic Molecule API Facility
Containment systems are essential in pharmaceutical manufacturing, ensuring product quality and…
Efficient and Reliable C&Q of Water and Steam Systems
Water and steam are essential in the pharmaceutical industry. Both are used for multiple purposes…
Starting a Pharmaceutical Sustainability Journey
There are everyday examples of climate impacts—an unexpected storm that creates flash flooding…
Professional Development Training
Microlearning: GAMP® Basic Principles – Computer Software Assurance (CSA)
Overview The " Computer Software Assurance (CSA)" section of the GAMP ® Basic Principles (T45) training course introduces the FDA’s evolving guidance on CSA, emphasizing a risk-based, patient-centric, and quality-focused approach to software validation and assurance. Moving away from traditional documentation-heavy practices, CSA encourages critical thinking, defect prevention, and efficient assurance activities tailored to the software’s intended use and risk level. Participants explore key concepts such as high vs. not-high process risk, scripted and unscripted testing methods, and…
ISPE Hands-On Biopharmaceutical Manufacturing Facilities and Processes Training
This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins. The course studies commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion, and adsorptive chromatography.
Hands-On Aseptic Processing & Annex 1
This course will focus on aseptic processing and quality management regarding pharmaceutical technology. The training course will provide ample time in clean rooms for various practical exercises, allowing participants to engage in hands-on operations. These sessions will occur in the clean rooms of the EASE platform.
Good Engineering Practice (GEP) Training Course
This course considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. GEP provides a foundation required across the pharmaceutical industry that other areas, such as GxP build upon. This course, based on ISPE Good Practice Guide: Good Engineering Practice (Second Edition) also defines and clarifies GEP as an enabling process for Quality Risk Management…
GMP Fundamentals: Eleven-Part Bundle Series
Obtain a 10% Savings by Purchasing All Eleven Courses Overview ISPE is presenting an eleven-part series that will focus on the fundamentals of good manufacturing practices (GMPs). The series provides an overview of the regulations pertaining to GMPs and covers topics such as: manufacturing controls, product distribution, plant hygiene, documentation practices, buildings & facilities, organizational structure, and more. This offering gives users access to all eleven modules of the series and is intended to introduce GMPs for the new pharmaceutical employee or to provide an annual refresher for…
Pharmaceutical Job Board
Videos
Webinars
ISPE in the News
Latest
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ISPE Regulatory Initiative: Product Quality Lifecycle Implementation (PQLI)®
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ISPE Podcast: Call for Proposals
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Balance empathy, accountability in performance management
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US FDA Issues Draft Guidance For Biosimilar Container Closures
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US FDA Distributed Manufacturing Proposal Reflects Shift In Focus
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Health Canada Pilot Would Prioritize Domestically Made Generics For Review
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Humedix Earns GMP Certification For Biopharmaceutical Line
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WuXi AppTec Increases Investment In Expansion
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Enzene Launches Platform For Biologics Production Scale-Up
- New Lab To Advance Biomanufacturing Automation
