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
Building Excellence in Pharma Manufacturing Through Rigor
Discover how pharmaceutical manufacturers can achieve faster startups, sustained compliance, and…
PE Articles
Precision at the Point of Use: The AquaTap™ Recirculating Faucet Advantage
In pharmaceutical and biotech environments, maintaining water quality at the point of use is…
PE Articles
Validation Using ISPE GAMP® 5 Methodology: How to Approach and Optimize Your Process
Approaching validation with the right strategy can save plenty of frustration and resources. A…
PE Articles
New Requirements for Aseptic Pharma Manufacturing
The revision of Annex 1 of the EU GMP Guidelines presents the pharmaceutical industry with a wide…
iSpeak Blog
Meet the 2025 ISPE Facility of the Year Awards (FOYA) Category Winner for Operations, Project Execution: Johnson & Johnson Innovative Medicine – Ireland
Johnson & Johnson Innovative Medicine, part of the Johnson & Johnson family of companies, develops…
iSpeak Blog
Pharmaceutical Engineering Reader Picks for July
From guidance on how to define temperature and humidity requirements and cleanroom design in…
iSpeak Blog
Breaking Down Barriers: Come to Charlotte, North Carolina, for the 2025 ISPE Annual Meeting & Expo, 26–29 October
You won't want to miss the 2025 ISPE Annual Meeting & Expo in Charlotte, North Carolina, USA 26–29…
iSpeak Blog
Meet the 2025 ISPE Facility of the Year Awards (FOYA) Category Winner for Operations – Operational Excellence: Johnson & Johnson Innovative Medicine – Italy
Johnson & Johnson’s facility in Latina, Italy, is a small molecule manufacturing site for global…
iSpeak Blog
More Efficient and Reliable Commissioning and Qualification (C&Q) of Water and Steam Systems
Water and steam are essential in the pharmaceutical industry. Both are used for multiple purposes…
iSpeak Blog
New ISPE Guide Helps Pharmaceutical Companies on Sustainability Journey
There are everyday examples of climate change—an unexpected storm that creates flash flooding…
iSpeak Blog
Sterile and Nonsterile Cleanroom Garments, Particle Emission Testing, Sterile and Nonsterile Gowning: Part 3 – Aseptic Facility Requirements
Introduction: Part 3 Cleanroom garments are worn by operators working in certified cleanrooms to…
PE Articles
Building Excellence in Pharma Manufacturing Through Rigor
Discover how pharmaceutical manufacturers can achieve faster startups, sustained compliance, and…
PE Articles
Precision at the Point of Use: The AquaTap™ Recirculating Faucet Advantage
In pharmaceutical and biotech environments, maintaining water quality at the point of use is…
PE Articles
Validation Using ISPE GAMP® 5 Methodology: How to Approach and Optimize Your Process
Approaching validation with the right strategy can save plenty of frustration and resources. A…
PE Articles
New Requirements for Aseptic Pharma Manufacturing
The revision of Annex 1 of the EU GMP Guidelines presents the pharmaceutical industry with a wide…
iSpeak Blog
Meet the 2025 ISPE Facility of the Year Awards (FOYA) Category Winner for Operations, Project Execution: Johnson & Johnson Innovative Medicine – Ireland
Johnson & Johnson Innovative Medicine, part of the Johnson & Johnson family of companies, develops…
iSpeak Blog
Pharmaceutical Engineering Reader Picks for July
From guidance on how to define temperature and humidity requirements and cleanroom design in…
iSpeak Blog
Breaking Down Barriers: Come to Charlotte, North Carolina, for the 2025 ISPE Annual Meeting & Expo, 26–29 October
You won't want to miss the 2025 ISPE Annual Meeting & Expo in Charlotte, North Carolina, USA 26–29…
iSpeak Blog
Meet the 2025 ISPE Facility of the Year Awards (FOYA) Category Winner for Operations – Operational Excellence: Johnson & Johnson Innovative Medicine – Italy
Johnson & Johnson’s facility in Latina, Italy, is a small molecule manufacturing site for global…
iSpeak Blog
More Efficient and Reliable Commissioning and Qualification (C&Q) of Water and Steam Systems
Water and steam are essential in the pharmaceutical industry. Both are used for multiple purposes…
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)
+Facilities of the Future (1)
+GAMP® (1)
+Good Manufacturing Practice (1)
+Manufacturing Operations (10)
+Microbiological & Viral Contamination Control (15)
+Oral Solid Dosage (2)
+Packaging (2)
+Pharma 4.0™ (1)
+Process Analytical Technology (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 (2)
+Sustainable Facilities, HVAC, & Controlled Environments (6)
+Validation (1)
+Community Discussions
Community Discussions
Sep 16, 2025
Artificial Intelligence
Sep 15, 2025
Information Systems
Sep 10, 2025
Sep 04, 2025
Information Systems
Quality
Validation
GAMP®
Sep 04, 2025
Quality Control
Sep 02, 2025
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
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…
Advanced Applications for Digital Twins in Pharma
With the help of Digital Twins, companies can achieve greater certainty and precision in making…
A Pharma 4.0™ Future for Brownfield Challenges
Pharmaceutical companies can use digital maturity assessments to address the challenges of upgrading…
Facility of the Year Awards Marks 20th Anniversary Honors Global Innovation in Pharma Manufacturing
The 2025 Facility of the Year Awards (FOYA) category winners were announced in May at the ISPE…
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…
Advanced Applications for Digital Twins in Pharma
With the help of Digital Twins, companies can achieve greater certainty and precision in making…
A Pharma 4.0™ Future for Brownfield Challenges
Pharmaceutical companies can use digital maturity assessments to address the challenges of upgrading…
Facility of the Year Awards Marks 20th Anniversary Honors Global Innovation in Pharma Manufacturing
The 2025 Facility of the Year Awards (FOYA) category winners were announced in May at the ISPE…
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…
Professional Development Training
ISPE Hands-On Biopharmaceutical Manufacturing Facilities and Processes Training
+Hands-On Aseptic Processing & Annex 1
+Good Engineering Practice (GEP) Training Course
+GMP Fundamentals: Eleven-Part Bundle Series
+Biopharmaceuticals: Webinar C> e ATMP
+Pharmaceutical Job Board
Videos
Webinars
Upcoming
On-Demand
ISPE in the News
Latest
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Up, up and away: In an aviation first from 1783, the Montgolfier brothers launched a hot air balloon carrying a duck, a sheep and what else?
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ISPE Training: Commissioning and Qualification Training Course, Online Live, 22-25 September
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Breaking Down Barriers: Come to Charlotte, North Carolina, for the 2025 ISPE Annual Meeting & Expo, 26-29 October
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ICH Implementing Post-Marketing Surveillance Guideline
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Bioprocess 5.0 Combines AI, Human Expertise
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Regulatory Expectations Rising for Cleanroom Sterility
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Lilly Announces $5B Manufacturing Site in Va.
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Sanofi Goes Digital to Reduce Changeover Times
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Align Supply Chain, EHS Initiatives to Improve Sustainability
- Coalition Develops Pharma Life Cycle Assessment Standard
