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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…
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…
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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…
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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…
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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)
- 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 Good Practice Guide: GxP Process Control Systems 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
Drug Shortages (3)
Facilities of the Future (1)
GAMP® (17)
- ISPE GAMP® Guide: Artificial Intelligence
- GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
- GAMP Good Practice Guide: GxP Process Control Systems 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)
- 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 Good Practice Guide: GxP Process Control Systems 2nd Edition
- 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
ISPE Hands-On Biopharmaceutical Manufacturing Facilities and Processes Training
This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins. The course studies commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion, and adsorptive chromatography.
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.
Hands-On Aseptic Processing & Annex 1
This course will focus on aseptic processing and quality management regarding pharmaceutical technology. The training course will provide ample time in clean rooms for various practical exercises, allowing participants to engage in hands-on operations. These sessions will occur in the clean rooms of the EASE platform.
Quality Events
High-level overview of quality event management principles and practices. This course offers a high-level summary of quality event topics as an addition to the Quality Events SOP Guidance Documents package. Instead of detailing how to carry out each task, it highlights why these elements are vital for a complete quality system. The course covers the core principles of root cause analysis, CAPA implementation, and effective recall and complaint handling, ensuring learners grasp their importance for regulatory compliance and operational excellence. By the end, participants will understand…
Good Engineering Practice (GEP) Training Course
This course considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. GEP provides a foundation required across the pharmaceutical industry that other areas, such as GxP build upon. This course, based on ISPE Good Practice Guide: Good Engineering Practice (Second Edition) also defines and clarifies GEP as an enabling process for Quality Risk Management…