The Workforce of the Future initiative ensures that recent graduates entering the industry, and our current workforce, have access to cutting-edge technical knowledge.
iSpeak Blog
Honoring a Pioneer: The Legacy of Jack Lysfjord
Some people contribute to an industry. Others help define it. Jack Lysfjord did the latter.
iSpeak Blog
Applied AI, Workforce Readiness, and the Future of Pharma Manufacturing
Artificial intelligence is rapidly transforming pharmaceutical manufacturing—but technology alone is…
iSpeak Blog
Shaping the Future of the Next Generation of Pharma Leaders
A Message from the President and CEO, ISPE Walk into any ISPE conference and you’ll sense a certain…
iSpeak Blog
Shaping Skills for a Changing Pharma Landscape: ISPE’s Professional Development Pathways
In an industry where scientific advancement moves swiftly and regulatory expectations continue to…
iSpeak Blog
Strengthening Community, Celebrating Excellence: A Look at the ISPE United Kingdom (UK) Affiliate’s Impact and Initiatives
Opening of the 2025 ISPE UK Annual Conference & Awards Dinner at the Etihad Stadium in Manchester…
iSpeak Blog
Benches Over Desktops: Considerations for Converting Office Space to Laboratory Facilities
Life science facilities are increasingly expanding their laboratory footprints to bring processes in…
Video
Panel Discussion - Women Leading the Future: Transforming Organizations Across Asia
Panel Discussion - Women Leading the Future: Transforming Organizations Across Asia Complimentary…
PE Articles
Emerging Leaders Editorial: From Kitchen to Pharma - Sustainability from Ancient Chinese Cuisine
In the heart of traditional Chinese kitchens lies a profound respect for resources: nothing is…
PE Articles
Women in Pharma® Editorial - Embracing the Future: Reflections on My Journey with Women in Pharma®
As I conclude my tenure as Chair of the Women in Pharma® International Steering Committee, I reflect…
iSpeak Blog
Graduate Students and PhD Research Candidates, Join ISPE!
Insights from ISPE Member Aershen Muheyati Members of the ISPE CaSA Chapter reviewed membership…
PE Articles
Emerging Leaders Editorial: Maintaining Quality Requires “Quality Thinking”
“Excellence, then, is not an act, but a habit,” wrote the historian and philosopher Will Durant…
Video
2025 ISPE FOYA Category Winner for Pharma 4.0 - CSL Behring
CSL Project Aurora is a significant base fractionation expansion initiative at the Broadmeadows…
Join the Conversation
As an ISPE member you can engage with 22 active CoPs, including new communities focused on Artificial Intelligence and Sustainability. Connect with experts and join the conversations: Become an ISPE member
ISPE members: Get more involved by volunteering.
Community Discussions
Community Discussions
Nov 06, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Oct 31, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Oct 20, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Oct 18, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Oct 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Webinars
iSpeak Blog Posts
Pharmaceutical Engineering® Magazine
PE Articles
Emerging Leaders Editorial: From Kitchen to Pharma - Sustainability from Ancient Chinese Cuisine
In the heart of traditional Chinese kitchens lies a profound respect for resources: nothing is…
PE Articles
Women in Pharma® Editorial - Embracing the Future: Reflections on My Journey with Women in Pharma®
As I conclude my tenure as Chair of the Women in Pharma® International Steering Committee, I reflect…
PE Articles
Emerging Leaders Editorial: Maintaining Quality Requires “Quality Thinking”
“Excellence, then, is not an act, but a habit,” wrote the historian and philosopher Will Durant…
PE Articles
Application of Strategic Skill Management in Pharma 4.0™
The complex transformation toward Pharma 4.0™ requires comprehensive skill management. This case…
PE Articles
Emerging Leaders Editorial: Retaining Hidden Talent - A Strategic Imperative Amidst Industry-Wide Scarcity
Like other industries, the pharmaceutical industry is struggling with pain points of inflation…
PE Articles
Women in Pharma® Editorial: Workforce of the Future - Women in Pharma® at the 2025 ISPE Europe Annual Conference
Each year, the ISPE Europe Annual Conference includes a dedicated Women in Pharma ® session…
PE Articles
ISPE Foundation News: International Women’s Day
Sarah Dubin, recipient of an ISPE Women in Pharma scholarship In honor of International Women’s Day…
PE Articles
Nurturing a Culture of Collaboration and Growth
Organizations must continually evolve and adapt in order to grow, sustain, and stay competitive. No…
PE Articles
Embracing the Human Side of Manufacturing
For companies focused on producing lifesaving treatments, the positive effects of employee health…
PE Articles
A Skill Management Framework for a Pharma 4.0™ Workforce
Pharma 4.0™ is driving fundamental industry changes and requires a comprehensive approach to…
PE Articles
Emerging Leaders Editorial: Mastering Constructive Disagreement in Times of Change
The expectations for the workforce joining the industry right now are slightly daunting. It can feel…
PE Articles
Women in Pharma® Editorial: Having It All
Being a working mom has shaped my career in unexpected ways. Early in my career, a colleague who had…
Videos
Guidance Documents
Active Pharmaceutical Ingredients (3)
Advanced Manufacturing (6)
- ISPE Good Practice Guide: ATMPs – Equipment Design and Qualification for Cellular Products
- ISPE Guide: Advanced Therapy Medicinal Products - Validation Methods and Controls Throughout the Cell and Gene Therapy Product Lifecycle
- Guide: ATMPs - Allogeneic Cell Therapy
- Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt
- Baseline Guide Vol 8: Pharma 4.0 1st Edition
- Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
Advanced Therapy Medicinal Products (2)
Artificial Intelligence (2)
Biotechnology (7)
- ISPE Good Practice Guide: Continuous Manufacturing of Biological Products
- Guide: ATMPs - Allogeneic Cell Therapy
- Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt
- Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
- Good Practice Guide: Development of Investigational Therapeutic Biological Products
- Guide: Biopharmaceutical Process Development & Manufacturing
- Guide: ATMPs - Autologous Cell Therapy
Commissioning & Qualification (6)
- 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
- GAMP Good Practice Guide: Testing GxP Systems 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 (7)
- 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)
- Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Data Integrity (19)
- GAMP Good Practice Guide: GxP Process Control Systems 3rd Edition.
- ISPE Good Practice Guide: Pharma 4.0™ – Holistic Digital Enablement
- ISPE GAMP® Guide: Artificial Intelligence
- ISPE Good Practice Guide: Digital Validation
- Baseline Guide Vol 8: Pharma 4.0 1st Edition
- GAMP Guide: Records & Data Integrity
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- GAMP Good Practice Guide: Manufacturing Execution Systems
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity by Design
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
Drug Shortages (3)
Facilities of the Future (1)
GAMP® (17)
- GAMP Good Practice Guide: GxP Process Control Systems 3rd Edition.
- ISPE GAMP® Guide: Artificial Intelligence
- GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
- GAMP Guide: Records & Data Integrity
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- GAMP Good Practice Guide: Manufacturing Execution Systems
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- GAMP RDI Good Practice Guide: Data Integrity by Design
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP 5 Guide 2nd Edition
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Testing GxP Systems 2nd Edition
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
Good Manufacturing Practice (9)
- 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
- Guide: 503B Compounding
- Baseline Guide Vol 1: Active Pharmaceutical Ingredient
Investigational Products (8)
- Comprehensive Guide to Clinical Materials
- Good Practice Guide: Comparator Management
- Good Practice Guide: Development of Investigational Therapeutic Biological Products
- Good Practice Guide: IMP Reverse Logistics
- Good Practice Guide: Harmonizing the Definition and Use of NIMPs
- Good Practice Guide: Clinical Supply Systems
- Good Practice Guide: Interactive Response Technology
- Introductory US Clinical Trial Materials Training Guide
Knowledge Management (8)
- ISPE Good Practice Guide: Pharma 4.0™ – Holistic Digital Enablement
- GAMP RDI Good Practice Guide: Data Integrity by Design
- Good Practice Guide: Knowledge Management in Pharmaceutical Industry
- APQ Guide: Cultural Excellence
- APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
- APQ Guide: Change Management (CM) System
- APQ Guide: Management Responsibilities & Review (MRR)
- APQ Guide: Corrective Action & Preventive Action (CAPA) System
Lifecycle Management (6)
- GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
- Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt
- Guide: Biopharmaceutical Process Development & Manufacturing
- PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles
- PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example
- APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
Manufacturing Operations (20)
- ISPE Good Practice Guide: Continuous Manufacturing of Biological Products
- ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms
- ISPE Guide: Sustainability
- 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
- 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: Biopharmaceutical Process Development & Manufacturing
- 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 (16)
- 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
- Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd 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)
- Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Oral Solid Dosage (3)
Packaging (3)
Pharma 4.0™ (3)
Process Analytical Technology (8)
- ISPE Good Practice Guide: Continuous Manufacturing of Biological Products
- ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms
- ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems (Third Edition)
- ISPE Good Practice Guide: Validation 4.0
- PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles
- PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example
- APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
- PQLI Guide: Part 4 - Process Performance & Product Quality Monitoring System
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 (9)
- ISPE Good Practice Guide: Digital Validation
- Guide: 503B Compounding
- Good Practice Guide: Process Validation
- APQ Guide: Cultural Excellence
- APQ Guide: Change Management (CM) System
- APQ Guide: Management Responsibilities & Review (MRR)
- APQ Guide: Corrective Action & Preventive Action (CAPA) System
- PQLI Guide: Part 3 - Change Management System
- The Cultural Excellence Report - Six Key Dimensions
Quality Control (2)
Quality by Design (7)
- ISPE Guide: Advanced Therapy Medicinal Products - Validation Methods and Controls Throughout the Cell and Gene Therapy Product Lifecycle
- ISPE Good Practice Guide: Validation 4.0
- Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
- Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition
- PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles
- PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
Regulatory (10)
- 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 1: Active Pharmaceutical Ingredient
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition
- GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition
- Good Practice Guide: Critical Utilities GMP Compliance
- 2023 ISPE Drug Shortages Prevention Model
- ISPE Readiness Report Bundle
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
Single Use Technologies & Disposables (1)
Sterile Products (3)
Supply Chain Management (6)
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
Validation (16)
- GAMP Good Practice Guide: GxP Process Control Systems 3rd Edition.
- ISPE Guide: Advanced Therapy Medicinal Products - Validation Methods and Controls Throughout the Cell and Gene Therapy Product Lifecycle
- ISPE Good Practice Guide: Validation 4.0
- ISPE Good Practice Guide: Digital Validation
- GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
- Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls
- GAMP Guide: Records & Data Integrity
- GAMP RDI Good Practice Guide: Data Integrity - Key Concepts
- GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records
- GAMP Good Practice Guide: Calibration Management 2nd Edition
- Good Practice Guide: Process Validation
- GAMP Good Practice Guide: Operation of GxP Computerized Systems
- GAMP Good Practice Guide: Enabling Innovation
- GAMP Good Practice Guide: Regulated Mobile Applications
- GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition
- GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition
Professional Development Training
Quality: Miscellaneous
High-level overview of quality event management principles and practices. Part 3 of the ISPE Quality Training Series Quality: Events Quality: Documentation Quality: Miscellaneous Quality: Miscellaneous is the third and final course in ISPE’s comprehensive three‑part Quality Training Series, following Quality: Events and Quality: Documentation. While the earlier courses focus on the identification, management, and documentation of quality events within a GMP environment, this course broadens the perspective to address a set of additional quality system elements essential to maintaining a…
Quality Control Analytical Laboratory Testing
Quality Control Analytical Lab Testing Fundamentals provides a foundational introduction to the essential laboratory practices that underpin Quality Control (QC) operations in pharmaceutical and biopharmaceutical environments. Designed for those new to QC testing or seeking to strengthen their understanding of core analytical principles, this course explores not only what happens in the QC laboratory, but why these practices are vital for ensuring product quality, regulatory compliance, and ultimately, patient safety. Through practical examples and structured guidance, learners will gain…
GAMP® AI Basic Principles Training Course – 2-Day
GAMP® AI guidance provides a pragmatic and effective framework for achieving AI-enabled computerized systems that are fit for intended use and aligned with current regulatory expectations. This course introduces participants to the requirements for AI-enabled computerized systems and internationally recognized methods of meeting those requirements.
Quality: Documentation
High-level overview of quality event management principles and practices. Part 2 of the ISPE Quality Training Series Quality: Events Quality: Documentation Quality: Miscellaneous This course provides a high-level overview of essential quality documentation practices and SOPs. Rather than focusing solely on completing individual forms, this course explains why elements such as SOPs, batch records, change control forms, and supporting documentation are critical to a robust pharmaceutical quality system. You’ll learn the key principles behind effective document creation, control, and lifecycle…
Microlearning: GAMP® Basic Principles – Legacy Systems
Overview The " Legacy Systems" section of the GAMP ® Basic Principles (T45) training course addresses the challenges and regulatory expectations surrounding operational GxP systems that lack sufficient validation or documentation. Participants learn how legacy systems arise from organizational changes to neglected validation and documentation, and why they pose compliance risks. Drawing guidance from PIC/S and EU Annex 11, the module emphasizes the need to demonstrate fitness for intended use, manage GxP risks, and maintain system control. Learners explore how to apply GAMP® 5 lifecycle…