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
When Analytics Meet Quality
Intersection of Analytical Techniques and Quality Management In today’s data-driven world, the…
iSpeak Blog
Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
In a world defined by rapid scientific progress and evolving market demands, the ability to adapt…
iSpeak Blog
Pharmaceutical Engineering® Reader Picks for April 2025
Each issue of Pharmaceutical Engineering ® covers a wide range of topics relevant to the…
Basic page
2025 ISPE FOYA Category Winner for Social Impact - Unmet Medical Needs
Bayer Healthcare LLC Location: Berkeley, California, USA Project: Cell Therapy Launch and…
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
Formulation Challenges in Lyophilized Products
Formulation challenges in pharmaceuticals are increasing in complexity due to the rise of…
PE Articles
ABM Clean Room Solutions for Life Science Companies
ABM uses advanced technology and precise tracking to ensure cleanroom compliance, prevent…
PE Articles
Presaturated Wipes: Simple and Powerful Contamination Control
Cleaning surfaces and equipment in controlled environments has historically involved a variety of…
PE Articles
Desiccant Dehumidification Future-Proofs Pharma Production
Environmental control plays a critical role in pharmaceutical manufacturing, particularly when it…
PE Articles
Assessing Containment Equipment and Systems with New ISPE Guide
Effective containment systems in a pharmaceutical manufacturing facility are essential to protect…
iSpeak Blog
When Analytics Meet Quality
Intersection of Analytical Techniques and Quality Management In today’s data-driven world, the…
iSpeak Blog
Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
In a world defined by rapid scientific progress and evolving market demands, the ability to adapt…
iSpeak Blog
Pharmaceutical Engineering® Reader Picks for April 2025
Each issue of Pharmaceutical Engineering ® covers a wide range of topics relevant to the…
Basic page
2025 ISPE FOYA Category Winner for Social Impact - Unmet Medical Needs
Bayer Healthcare LLC Location: Berkeley, California, USA Project: Cell Therapy Launch and…
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
Formulation Challenges in Lyophilized Products
Formulation challenges in pharmaceuticals are increasing in complexity due to the rise of…
PE Articles
ABM Clean Room Solutions for Life Science Companies
ABM uses advanced technology and precise tracking to ensure cleanroom compliance, prevent…
PE Articles
Presaturated Wipes: Simple and Powerful Contamination Control
Cleaning surfaces and equipment in controlled environments has historically involved a variety of…
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
Jun 06, 2025
Sustainable Facilities, HVAC, & Controlled Environments
May 22, 2025
Apr 24, 2025
Validation
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Apr 08, 2025
Data Integrity
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 Webinar: Introduction to the ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data - Good eClinical Practice (Second Edition)
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A Visit to Chugai's Award-Winning Tokyo Facility: A Benchmark in Social Impact and Excellence
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TurboFil Introduces MediFil Cart for Precision Vial Filling
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Karnataka Pharma Leads in Revised Schedule M Compliance
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Pharmaceutical Tariffs, National Security Go Hand in Hand
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Accumulus, Veeva to Enhance Life Sciences Connectivity
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Improved Pharma Expands at Purdue Tech Center in Ind.
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Why CPOs, CDMOs Must Align to Drive Pharma Innovation
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Understanding Sample Size in Cleaning Process Capability
- China's Biotech Sector Rapidly Closing Gap with US
