Mission
ISPE's Women in Pharma® group is a member-exclusive initiative committed to bridging gender, cultural, organizational, and geographic boundaries to maximize the impact women have on the pharmaceutical industry, and their respective communities.
Women in Pharma® aspires to create a pharmaceutical industry that is equitable, inclusive, free of biases and stereotypes, where diversity of thought thrives.
Vision
A pharmaceutical industry that is equitable and inclusive, free of biases and stereotypes, where diversity of thought thrives.
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.
Video
Panel Discussion - Women Leading the Future: Transforming Organizations Across Asia
Panel Discussion - Women Leading the Future: Transforming Organizations Across Asia Complimentary…
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
From Imposter to Impact: Reinventing Careers with Confidence at the 2025 ISPE Annual Meeting & Expo
Women in Pharma ®-Led Workshop | 2025 ISPE Annual Meeting & Expo
PE Articles
Women in Pharma® Editorial: Get Involved With Women in Pharma® This Fall
As fall approaches, it brings with it one of the most anticipated events in our industry: the 2025…
iSpeak Blog
Member Spotlight: Allyssa Wilcox
Allyssa Wilcox is a Sourcing Manager for Site Operations Procurement at AstraZeneca. She is an ISPE…
PE Articles
Women in Pharma® Editorial: The Transformative Power of a Mentor
Talk show host Oprah Winfrey once said, “A mentor is someone who allows you to see hope inside…
iSpeak Blog
ISPE Women in Pharma® Update: Q1–Q2 2025 Activities
A Message from the Chair of the Women in Pharma ® International Steering Committee, Vivien Santillan…
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
Adaptable Leadership Workshop: Women in Pharma® Hosts Transformative Leadership Workshop at 2024 ISPE Annual Meeting & Expo
At the 2024 ISPE Annual Meeting & Expo, Women in Pharma ® hosted the transformative Adaptable…
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…
Video
Secrets in the Digital Transformation Vibe
Secrets in the Digital Transformation Vibe Powered and Led by Women in Pharma ® This session…
iSpeak Blog
Celebrating International Women’s Day with Women in Pharma®
As we approach International Women’s Day 2025, this year’s theme highlights the importance of…
Community Discussions
Community Discussions
Webinars
Pharmaceutical Engineering Magazine 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…
Women in Pharma® Editorial: Get Involved With Women in Pharma® This Fall
As fall approaches, it brings with it one of the most anticipated events in our industry: the 2025…
Women in Pharma® Editorial: The Transformative Power of a Mentor
Talk show host Oprah Winfrey once said, “A mentor is someone who allows you to see hope inside…
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…
Adaptable Leadership Workshop: Women in Pharma® Hosts Transformative Leadership Workshop at 2024 ISPE Annual Meeting & Expo
At the 2024 ISPE Annual Meeting & Expo, Women in Pharma ® hosted the transformative Adaptable…
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…
Women in Pharma® Editorial: Empowering Women in Pharma® for Collaboration and Growth
In the ever-evolving landscape of the pharmaceutical industry, the Women in Pharma® Steering…
Women in Pharma® Editorial: A Year of Remarkable Achievements
As we approach the end of another impactful year, it is a pleasure to reflect on the outstanding…
Women in Pharma® Editorial: Empowering Women in Regulatory Affairs
In the dynamic realm of regulatory affairs, a significant transformation is unfolding—a movement…
Women in Pharma® Editorial: Women in Pharma® at the 2024 ISPE Annual Meeting & Expo
Long gone are the days of early morning Women in Pharma breakfast meetings at ISPE international…
Women in Pharma® Editorial: An Era of Innovation and Emerging Technologies
The emergence of new modalities and innovations on drug development and research, such as advanced…
International Women’s Day Is 8 March
The new year is here and, with that, another International Women’s Day approaches! This incredibly…
Guidance Documents
Active Pharmaceutical Ingredients (3)
Advanced Manufacturing (6)
- Good Practice Guide: ATMPs – Equipment Design & Qualification for Cellular Products
- ISPE Guide: ATMPs – Validation Methods & Controls
- Guide: ATMPs - Allogeneic Cell Therapy
- Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt
- Baseline Guide Vol 8: Pharma 4.0
- Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
Advanced Therapy Medicinal Products (2)
Artificial Intelligence (2)
Biotechnology (7)
- 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)
- Good Practice Guide: C&Q of Water & Steam Systems 3rd Edition
- Good Practice Guide: Heating, Ventilation & Air Conditioning 2nd 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)
Critical Utilities (7)
- Good Practice Guide: C&Q of Water & Steam Systems 3rd 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)
- Good Practice Guide: Pharma 4.0™ – Holistic Digital Enablement
- GAMP Guide: Artificial Intelligence
- Good Practice Guide: Digital Validation
- Baseline Guide Vol 8: Pharma 4.0
- 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)
- 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)
- QMS SOP Template: Product Recall Management
- QMS SOP Template: Product Quality Complaints
- QMS SOP Template: Out-of-Specification
- QMS SOP Template: Investigations
- QMS SOP Template: Environmental Monitoring Excursions
- QMS SOP Template: Deviation Management
- QMS SOP Template: CAPA Management
- Guide: 503B Compounding
- Baseline Guide Vol 1: Active Pharmaceutical Ingredients
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)
- 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)
- Good Practice Guide: Continuous Manufacturing of Biological Products
- Good Practice Guide: Control Strategy Development for CM of OSD Forms
- Guide: Sustainability
- QMS SOP Template: Product Recall Management
- QMS SOP Template: Product Quality Complaints
- QMS SOP Template: Out-of-Specification
- QMS SOP Template: Investigations
- QMS SOP Template: Environmental Monitoring Excursions
- QMS SOP Template: Deviation Management
- QMS SOP Template: CAPA Management
- Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd 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)
- Good Practice Guide: SMEPAC - Standardized Methodology for the Eval of Pharm Airborne Particle Emissions 3rd Edition
- Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd 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)
- Good Practice Guide: Continuous Manufacturing of Biological Products
- Good Practice Guide: Control Strategy Development for CM of OSD Forms
- Good Practice Guide: C&Q of Water & Steam Systems 3rd Edition
- 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)
- 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: ATMPs – Validation Methods & Controls
- 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)
- Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
- Good Practice Guide: Heating, Ventilation & Air Conditioning 2nd Edition
- Baseline Guide Vol 1: Active Pharmaceutical Ingredients
- 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)
- Good Practice Guide: SMEPAC - Standardized Methodology for the Eval of Pharm Airborne Particle Emissions 3rd Edition
- Good Practice Guide: Heating, Ventilation & Air Conditioning 2nd 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: ATMPs – Validation Methods & Controls
- Good Practice Guide: Validation 4.0
- 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…
iSpeak Blog Posts
White Papers
November / December 2025
In This Issue: We dive into sustainable practices in the pharma industry and effective ways to…
September / October 2025
As regulatory trends and quality initiatives continue to evolve in the pharmaceutical industry, this…
July / August 2025
The AI Paradox Cover: The increasing digitalization of the pharmaceutical and medical device…
