Content focuses on the interactions of multidisciplinary functions and discusses the scientific application of experimental design methodologies as part of the product manufacturing process. Individual topics could include formulation, clinical phases, manufacturing, technology transfer, production scale-up, and optimization.
PE Articles
New ISPE Guide: ATMPs – Validation Methods and Controls Throughout the Cell and Gene Therapy Lifecycle
Advanced therapy medicinal products (ATMPs) represent a revolutionary frontier in medicine, offering…
iSpeak Blog
Shaping the Future of Advanced Therapies
Advanced therapy medicinal products (ATMPs) are redefining the boundaries of modern medicine. These…
PE Articles
Toward a Holistic Control Strategy: Bridging Gaps Across the Product Lifecycle
This article defines what constitutes a holistic control strategy in pharmaceutical development and…
iSpeak Blog
Update on Transportable and Point of Care Manufacturing
Pharmaceutical manufacturing is at a turning point. For decades, large-scale centralized facilities…
Product
ISPE Good Practice Guide: Continuous Manufacturing of Biological Products
Published: December 2025 Pages: 200 Table of Contents Special Pricing for Emerging Economies…
iSpeak Blog
Accelerating Pharma Manufacturing: Automation and Robotics in Pharma 4.0™
Automation and robotics aren’t just futuristic concepts—they’re practical solutions reshaping how…
iSpeak Blog
PAT as a Catalyst for Digital Transformation: Lessons for Engineers and Pharma Professionals at the 2025 ISPE Pharma 4.0™ Conference
For the first time in ISPE Pharma 4.0™ Conference history, ISPE will dedicate an entire track for…
PE Articles
Oligonucleotide Manufacturing Scaling Challenges for Undruggable Targets
Oligonucleotide therapies hold great promise for treating a wide range of diseases, including the…
PE Articles
Platform Drug Delivery Devices for Regulatory Submissions
The development of platform drug delivery devices for combination products offers a transformative…
PE Articles
The Puzzle of Sustainable Pharma Packaging: Drivers, Trade-Offs, and Best Practices
Crafting a sustainable packaging strategy for the pharmaceutical industry is complex and requires…
PE Articles
Expanding Extended Producer Responsibility: Challenges and Opportunities
Pharmaceuticals are not only regulated by traditional pharmaceutical legislation but are also…
Video
Future-Proofing Pharma & Personal Care: How Life Cycle Assessments & Carbon Footprinting Drive Real Change
Future-Proofing Pharma & Personal Care: How Life Cycle Assessments & Carbon Footprinting Drive Real…
Guidance Documents
Active Pharmaceutical Ingredients (1)
Drug Shortages (1)
Good Manufacturing Practice (7)
- ISPE Quality Management System Standard Operating Procedure Template: Product Recall Management
- ISPE Quality Management System Standard Operating Procedure Template: Product Quality Complaint
- ISPE Quality Management System Standard Operating Procedure Template: Out-of-Specification
- ISPE Quality Management System Standard Operating Procedure Template: Investigation
- ISPE Quality Management System Standard Operating Procedure Template: Environmental Monitoring Excursion
- ISPE Quality Management System Standard Operating Procedure Template: Deviation Management
- ISPE Quality Management System Standard Operating Procedure Template: CAPA Management
Investigational Products (1)
Knowledge Management (4)
Lifecycle Management (1)
Manufacturing Operations (7)
- ISPE Quality Management System Standard Operating Procedure Template: Product Recall Management
- ISPE Quality Management System Standard Operating Procedure Template: Product Quality Complaint
- ISPE Quality Management System Standard Operating Procedure Template: Out-of-Specification
- ISPE Quality Management System Standard Operating Procedure Template: Investigation
- ISPE Quality Management System Standard Operating Procedure Template: Environmental Monitoring Excursion
- ISPE Quality Management System Standard Operating Procedure Template: Deviation Management
- ISPE Quality Management System Standard Operating Procedure Template: CAPA Management
Process Analytical Technology (1)
Project Management (6)
- Good Practice Guide: Technology Transfer 3rd Edition
- Good Practice Guide: Operations Management
- Good Practice Guide: Project Management for the Pharmaceutical Industry
- Good Practice Guide: Good Engineering Practice 2nd Edition
- Good Practice Guide: Management of Engineering Standards
- The Cultural Excellence Report - Six Key Dimensions
Quality Assurance (3)
Supply Chain Management (1)
Community Discussions
Community Discussions
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Jan 06, 2026
Dec 16, 2025
Dec 12, 2025
Dec 08, 2025
Critical Utilities
Nov 27, 2025
Information Systems
Validation
ISPE in the News
Latest
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20 Years of ISPE Argentina: Driving Regional Collaboration and the Future of Pharma
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Global Pharmaceutical Manufacturing Leadership Forum (GPMLF) White Paper is Now Available
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ISPE SmartBrief Will Not Be Published Monday
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Serum Institute Of India To Produce Rift Valley Fever Vaccine
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Layoffs At US Safety Research Agency Reversed
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US FDA Urged To Update Post-Approval Manufacturing Rules
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BD To Invest In Prefillable Syringe Line At Neb. Plant
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EMA, US FDA Issue Guidelines For AI In Drug Development
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Thermo Fisher To Phase Out Operations At Western N.C. Plant
- Phlow, Enveda Train AI For API Manufacturing
iSpeak Blog Posts
Pharmaceutical Job Board
Pharmaceutical Engineering Magazine Articles
New ISPE Guide: ATMPs – Validation Methods and Controls Throughout the Cell and Gene Therapy Lifecycle
Advanced therapy medicinal products (ATMPs) represent a revolutionary frontier in medicine, offering…
Toward a Holistic Control Strategy: Bridging Gaps Across the Product Lifecycle
This article defines what constitutes a holistic control strategy in pharmaceutical development and…
Oligonucleotide Manufacturing Scaling Challenges for Undruggable Targets
Oligonucleotide therapies hold great promise for treating a wide range of diseases, including the…
Platform Drug Delivery Devices for Regulatory Submissions
The development of platform drug delivery devices for combination products offers a transformative…
The Puzzle of Sustainable Pharma Packaging: Drivers, Trade-Offs, and Best Practices
Crafting a sustainable packaging strategy for the pharmaceutical industry is complex and requires…
Expanding Extended Producer Responsibility: Challenges and Opportunities
Pharmaceuticals are not only regulated by traditional pharmaceutical legislation but are also…
Industrial ATMP Manufacturing: Digitization’s Role in Aseptic Manufacturing for ATMPs
Over the past decade, Advanced Therapy Medicinal Products (ATMPs) have introduced a significant…
Volunteer Profile: Nina S. Cauchon, PhD, Product Quality Lifecycle Implementation (PQLI)® Committee Co-Chair
Nina S. Cauchon is Director Regulatory Affairs (RA) Chemistry, Manufacturing, and Controls (CMC) at…
Volunteer Profile: Celeste Frankenfeld Lamm, PhD, Product Quality Lifecycle Implementation (PQLI)® Committee Co-Chair
Celeste Frankenfeld Lamm encourages young professionals to identify and pursue the aspects of their…
Expand Your Knowledge and Network at ISPE Annual Meeting & Expo
As professionals in pharmaceutical engineering, we are challenged to develop medications and…
Ensuring Drug Product Safety Compliance Strategies Under USP 665 and 1665
The United States Pharmacopeia (USP) Packaging and Distribution Expert Committee approved chapters…
Barriers to Innovation in Pharmaceutical Manufacturing Insights From Five Case Studies
In April 2023, ISPE launched a survey to understand the sources of barriers to technological…
White Papers
November / December 2025
In This Issue: We dive into sustainable practices in the pharma industry and effective ways to…
May / June 2025
The ATMP Issue: In this issue, we focus on the manufacturing of advanced therapy medicinal products…
November / December 2024
Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
November / December 2023
There is much that large-scale commercial stem cell therapy processes can adopt from the existing…
Videos
Professional Development Training
ISPE Hands-On Controlled Production of Drug Substance and Drug Product in Biomanufacturing
This advanced, hands-on training opportunity will implement the global body of knowledge of ISPE to advance the understanding of drug substance and drug product manufacturing, utilizing the commercial scale operational aspects of the Biomanufacturing Training and Education Center (BTEC - located on North Carolina State Centennial Campus in Raleigh, NC) through a series of immersive and hands-on exercises that address current, real world manufacturing challenges.
ICH Q7: API Guidelines
The ICH Q7 guideline ensures consistent quality and safety in the production of Active Pharmaceutical Ingredients (APIs) by defining globally recognized Good Manufacturing Practices (GMP) for all stages of API manufacturing.
ICH Q9(R1): Guidelines on Pharmaceutical Risk Management
Delivery Mode: Webinar An introduction to the ICH Q9(R1): Guidelines on Pharmaceutical Risk Management. This lesson covers the fundamentals for assessing and mitigating risks during drug product lifecycles and incorporates the latest requirements from ICH Q9(R1), which was updated in 2023, and supports and sets the foundation for a safety and quality-centric approach. By integrating with other ICH standards, it sets the foundation for a safety and quality-centric approach. CEUs are provided once you achieve an 80% passing grade and complete the evaluation. The course is self-paced. On average…
ICH Q6A: Specifications, Test Procedures, and Acceptance Criteria for New Drug Substances and Products
Delivery Mode: Webinar This course covers testing and quality control requirements in marketing authorization/new drug applications, emphasizing ICH guidelines. It focuses on ICH Q6A, detailing test procedures and acceptance criteria for new drug substances/products to ensure global consistency and safety. The course also integrates later guidelines (ICH Q8, Q9, Q10, Q11), introducing science and risk-based approaches. Participants will learn to navigate global marketing authorization/new drug applications, contributing to high-quality pharmaceutical product development. CEUs are provided once…
Biopharmaceuticals: Webinar C> e ATMP
Biopharmaceuticals: Webinar de treinamento em C> e ATMP Visão geral Este webinar é uma gravação do novo curso de instrutor que é um curso de nível avançado sobre therapies C e Gene T (C>) e Medicamentos de Terapia Avançada (ATMP). O curso também fornece umavisão geral dos componentes mais comuns e estabelecidos que são aproveitados em produtos C> (por exemplo, plasmídeos, mRNA, nanopartículas lipídicas, vetores virais), cobrindo terminologia, processos de fabricação e subsequente caracterização analítica de os componentes fabricados e os produtos terapêuticos. As plataformas de células T…