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.
Video
FOYA Category Social Impact: Chugai Pharma Manufacturing Co, Ltd
UK4 is a biological drug substance manufacturing facility that was designed and built under a “Three…
iSpeak Blog
Navigating the Latest US FDA Draft Guidelines on Use of Decentralized Clinical Trial Designs
The landscape of clinical trials has evolved significantly with the pandemic and interest in…
iSpeak Blog
The Pharmaceutical Industry’s Mission to Advance the Next Generation of Medicines in Collaboration with Regulators
The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of…
Video
Attend the 2024 ISPE Annual Meeting & Expo
Attend the 2024 ISPE Annual Meeting & Expo Our comprehensive education program offers cutting-edge…
iSpeak Blog
The Future of ATMPs: Insights, Opportunities, and Innovations at the 2024 ISPE Annual Meeting
Globally, there is an increase in approved advanced therapy medicinal products (ATMPs), with…
iSpeak Blog
Unlock New Insights and Innovations: Explore the 2024 ISPE Annual Meeting & Expo Education Tracks
The 2024 ISPE Annual Meeting & Expo is the pharmaceutical industry’s gateway to discovering the…
iSpeak Blog
Pharma 4.0™ and Annex 1 – The Perfect Fit
What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to…
iSpeak Blog
Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
As the global pharmaceutical industry continues to evolve, staying ahead of the curve is more…
iSpeak Blog
Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
As the pharmaceutical landscape rapidly evolves, staying informed and connected with industry…
iSpeak Blog
2024 ISPE FOYA Category Winner for Social Impact: Chugai Pharma Manufacturing Co., Ltd.
Pharma Manufacturing Co., Ltd. has been awarded the 2024 ISPE FOYA Category Winner for Social Impact…
iSpeak Blog
Message From the Chair: Why Attend the 2025 ISPE Facilities of the Future Conference
The 2025 Facilities of the Future Conference will explore innovations in facility design and…
iSpeak Blog
Innovation Meets Talent: 2024 ISPE Annual Meeting & Expo Tackles the Future of Pharmaceutical Workforce
The unstoppable progress in technology and scientific knowledge is reshaping our industry. It is…
Video
FOYA Category Social Impact: Chugai Pharma Manufacturing Co, Ltd
UK4 is a biological drug substance manufacturing facility that was designed and built under a “Three…
iSpeak Blog
Navigating the Latest US FDA Draft Guidelines on Use of Decentralized Clinical Trial Designs
The landscape of clinical trials has evolved significantly with the pandemic and interest in…
iSpeak Blog
The Pharmaceutical Industry’s Mission to Advance the Next Generation of Medicines in Collaboration with Regulators
The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of…
Video
Attend the 2024 ISPE Annual Meeting & Expo
Attend the 2024 ISPE Annual Meeting & Expo Our comprehensive education program offers cutting-edge…
iSpeak Blog
The Future of ATMPs: Insights, Opportunities, and Innovations at the 2024 ISPE Annual Meeting
Globally, there is an increase in approved advanced therapy medicinal products (ATMPs), with…
iSpeak Blog
Unlock New Insights and Innovations: Explore the 2024 ISPE Annual Meeting & Expo Education Tracks
The 2024 ISPE Annual Meeting & Expo is the pharmaceutical industry’s gateway to discovering the…
iSpeak Blog
Pharma 4.0™ and Annex 1 – The Perfect Fit
What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to…
iSpeak Blog
Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
As the global pharmaceutical industry continues to evolve, staying ahead of the curve is more…
iSpeak Blog
Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
As the pharmaceutical landscape rapidly evolves, staying informed and connected with industry…
iSpeak Blog
2024 ISPE FOYA Category Winner for Social Impact: Chugai Pharma Manufacturing Co., Ltd.
Pharma Manufacturing Co., Ltd. has been awarded the 2024 ISPE FOYA Category Winner for Social Impact…
Guidance Documents
Advanced Manufacturing (3)
+Advanced Therapy Medicinal Products (1)
+Biotechnology (3)
+Commissioning & Qualification (4)
+Compounding (2)
+Containment (4)
+Critical Utilities (8)
+Data Integrity (2)
+GAMP® (1)
+Good Manufacturing Practice (1)
+Manufacturing Operations (8)
+Microbiological & Viral Contamination Control (16)
+Oral Solid Dosage (2)
+Packaging (2)
+Pharma 4.0™ (1)
+Quality Assurance (1)
+Quality Control (2)
+Quality by Design (2)
+Regulatory (3)
+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 08, 2025
Validation
Apr 08, 2025
Data Integrity
Apr 07, 2025
Advanced Manufacturing
Biotechnology
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Active Pharmaceutical Ingredients
Mar 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Mar 20, 2025
Mar 20, 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
Gene Editing and Facility Retrofits for CRISPR and Beyond
With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies…
Repurposing a US Cell Therapy Facility for Flexibility and EU Compliance
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
2024 ISPE Facilities of the Future Conference: Keynote Presentations
The 2024 ISPE Facilities of the Future Conference opened on 29 January in San Francisco, California…
Continuous Buffer Management System: Large-Scale Buffer Preparation
Although traditional tank farm systems have long been the cornerstone of buffer preparation, they…
Front-End Design of Personalized Medicine Facilities
The commercialization of personalized medicine has ushered in demand for a new type of facility…
Data Analysis of Contamination Control Strategies for Production
On 25 August 2023, the long-awaited revision to Annex 1 became effective, introducing significant…
Room Differential Pressures in Facility Design: Fundamentals
The expectations for room differential pressures to maintain air quality in pharmaceutical facility…
Experts Create Examples of C&Q Deliverables
In 2019, ISPE released the Second Edition of the ISPE Baseline® Guide Vol 5: Commissioning and…
A Guide to Unique Identification of Glass Primary Containers
The new ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in…
New Guide for Compounding Pharmacies
In April 2024, ISPE published the ISPE Guide: 503A Compounding - Regulatory Basis and Industry Good…
Acceptable Discoloration Levels on Pharmaceutical Weld Beads
Welds used in biopharmaceutical manufacturing must meet critical criteria to maintain a defined…
Automation Supports ESG Goals for Pharma Facility Conversion
Implementing advanced automation technologies is a strategic move that can amplify the positive…
Gene Editing and Facility Retrofits for CRISPR and Beyond
With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies…
Repurposing a US Cell Therapy Facility for Flexibility and EU Compliance
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
2024 ISPE Facilities of the Future Conference: Keynote Presentations
The 2024 ISPE Facilities of the Future Conference opened on 29 January in San Francisco, California…
Continuous Buffer Management System: Large-Scale Buffer Preparation
Although traditional tank farm systems have long been the cornerstone of buffer preparation, they…
Front-End Design of Personalized Medicine Facilities
The commercialization of personalized medicine has ushered in demand for a new type of facility…
Data Analysis of Contamination Control Strategies for Production
On 25 August 2023, the long-awaited revision to Annex 1 became effective, introducing significant…
Room Differential Pressures in Facility Design: Fundamentals
The expectations for room differential pressures to maintain air quality in pharmaceutical facility…
Experts Create Examples of C&Q Deliverables
In 2019, ISPE released the Second Edition of the ISPE Baseline® Guide Vol 5: Commissioning and…
A Guide to Unique Identification of Glass Primary Containers
The new ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in…
New Guide for Compounding Pharmacies
In April 2024, ISPE published the ISPE Guide: 503A Compounding - Regulatory Basis and Industry Good…
Professional Development Training
GMP Fundamentals: Eleven-Part Bundle Series
+Biopharmaceuticals: Webinar C> e ATMP
+Produtos Biofarmacêuticos: Aspectos CMC
+GMP Fundamentals: Packaging & Labeling Control
+GMP Fundamentals: Buildings and Facilities
+Pharmaceutical Job Board
Videos
Webinars
Upcoming
On-Demand
ISPE in the News
Latest
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ISPE Members: Volunteer with ISPE
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ISPE Webinar: QRM Based Integrated C&Q Series - Engineering Change Management (ECM)
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Belgian Regulators Sharpen ATMP Expertise
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AI Can Streamline Quality Auditing
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Novartis Plans $23B US Investment
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Buffer Recycling Feasible in Downstream Processes
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Automation, AI Could Cut CGT Production Costs
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Experts Present Framework for PAT in Biopharma Manufacturing
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ISPE Delivers ICH Q12 Training to Singapore's Health Authority
- Coming Soon and Recently Published ISPE Guidance Documents
