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
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PE Articles
Women in Pharma® Editorial: The Strength in Continuous Improvement and Quality
In the daily balance between operations and other departments within end-to-end manufacturing…
iSpeak Blog
ISPE Member Spotlight: Keira Mull on Driving Growth, Innovation, and Mentorship as an Emerging Leader
Driven by a passion for science, problem-solving, and improving patient outcomes, Keira Mull is…
iSpeak Blog
Women in Pharma® at the 2026 ISPE Annual Meeting and Expo: Leadership, Continuous Improvement, AI, and Networking Opportunities
Professionals attending the 2026 ISPE Annual Meeting and Expo, taking place 18-21 October in…
PE Articles
Women in Pharma® Editorial: Resilience Is Not a Trait— It’s a Daily Practice
In a high-pressure, always-on world, resilience has become one of the most sought-after capabilities…
iSpeak Blog
Integrating Artificial Intelligence into Inspection Readiness and Regulatory Response Development: A Technical Perspective and Case Study
Regulatory inspections by the US Food and Drug Administration (US FDA) and other global authorities…
PE Articles
Women in Pharma®: From Talent Shortage to Strategy: Rethinking Career Paths in Life Sciences
Keeping women on the path to leadership requires access to opportunities, mentorship, appreciation…
PE Articles
Women in Pharma®: Igniting Global Connection, Innovation, and Impact
Women in Pharma continues to be a driving force behind ISPE’s mission to advance pharmaceutical…
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
ISPE Member Spotlight: Allyssa Wilcox
Allyssa Wilcox is a Sourcing Manager for Site Operations Procurement at AstraZeneca. She is an ISPE…
Community Discussions
Community Discussions
Webinars
Pharmaceutical Engineering Magazine Articles
Women in Pharma® Editorial: The Strength in Continuous Improvement and Quality
In the daily balance between operations and other departments within end-to-end manufacturing…
Women in Pharma® Editorial: Resilience Is Not a Trait— It’s a Daily Practice
In a high-pressure, always-on world, resilience has become one of the most sought-after capabilities…
Women in Pharma®: From Talent Shortage to Strategy: Rethinking Career Paths in Life Sciences
Keeping women on the path to leadership requires access to opportunities, mentorship, appreciation…
Women in Pharma®: Igniting Global Connection, Innovation, and Impact
Women in Pharma continues to be a driving force behind ISPE’s mission to advance pharmaceutical…
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…
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 (9)
- Guide: RNA-Based Therapeutics Manufacturing
- Guide: Oligonucleotide and Peptide Manufacturing Facilities
- 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 (5)
- 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
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)
- Good Practice Guide: Sampling for Pharma Water, Steam, & Process Gases 2nd Edition
- 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)
Data Integrity (18)
- 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: 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: Testing GxP Systems 3rd Edition
- 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: 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 (10)
- GAMP Good Practice Guide: Testing GxP Systems 3rd Edition
- 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
HVAC, Sustainable Facilities, & 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
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 (9)
- ISPE Guide: Quality Risk Management
- 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 (7)
- ISPE Guide: Quality Risk Management
- 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 (22)
- Guide: RNA-Based Therapeutics Manufacturing
- Guide: Oligonucleotide and Peptide Manufacturing Facilities
- 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 (18)
- Guide: RNA-Based Therapeutics Manufacturing
- Guide: Oligonucleotide and Peptide Manufacturing Facilities
- Good Practice Guide: Sampling for Pharma Water, Steam, & Process Gases 2nd Edition
- 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)
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 (10)
- GAMP Good Practice Guide: Testing GxP Systems 3rd Edition
- Good Practice Guide: Process Validation
- ISPE Good Practice Guide: Digital Validation
- Guide: 503B Compounding
- 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 (1)
Quality by Design (8)
- ISPE Guide: Quality Risk Management
- 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)
Validation (16)
- Good Practice Guide: Process Validation
- 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
- 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
Commissioning and Qualification Microlearning: Periodic Review
The "Periodic Review" section of the Science & Risk-based Commissioning and Qualification (T40) training course examines how periodic review supports the continued maintenance of systems in a validated and qualified state. Participants explore the regulatory expectation that systems remain suitable for their intended purpose through lifecycle controls such as change control, maintenance, calibration, deviation management, and performance monitoring. The module also introduces a risk-based approach to determining periodic review frequency, including the use of review categories based on system…
Commissioning and Qualification Microlearning: Process Control and Automation
The "Process Control and Automation" section of the Science & Risk-based Commissioning and Qualification (T40) training course examines how GAMP® Quality Risk Management principles can be integrated with science- and risk-based C&Q for process control systems. Participants explore the relationship between manufacturing systems, process equipment, sensors, actuators, and Process Control Systems (PCS), as well as how product and process knowledge, Critical Quality Attributes (CQAs), and Critical Process Parameters (CPPs) inform automation and control requirements. The module also covers the…
Commissioning and Qualification Microlearning: Acceptance and Release
The "Acceptance & Release" section of the Science & Risk-based Commissioning and Qualification (T40) training course examines the final review and formal release of systems following the commissioning and qualification activities. Participants explore how testing results, discrepancies, engineering changes, and required quality system elements are reviewed to determine whether a system is suitable for manufacturing operations, the next stage of qualification, or use in PPQ or commercial production. The module also covers the transition of system ownership from the project team to operations…
Commissioning and Qualification Microlearning: Good Documentation Practice for Commissioning and Qualification
The "Good Documentation Practice for C&Q" section of the Science & Risk-based Commissioning and Qualification (T40) training course examines the documentation principles used to support clear, accurate, and reliable C&Q records. Participants explore how Good Documentation Practice supports data integrity through records that are attributable, legible, contemporaneously recorded, original or a true copy, and accurate. The module also compares commissioning and qualification documentation, including differences in approval, testing strategy, acceptance criteria, engineering judgment, Quality…
Commissioning and Qualification Microlearning: Implementation Strategy for New and Legacy Systems
The "Implementation Strategy for New & Legacy Systems" section of the Science & Risk-based Commissioning and Qualification (T40) training course examines how organizations can transition to a science- and risk-based C&Q approach for both new and existing systems. Participants explore the importance of organizational readiness, senior management support, quality systems, Good Engineering Practice (GEP), staff training, and a defined implementation plan when introducing a new C&Q strategy. The module also covers how the approach can be adapted for new projects, major changes, minor changes, and…
iSpeak Blog Posts
White Papers
September / October 2026
This issue examines the intersection of quality and regulatory innovation, tracing the evolution of…
July / August 2026
This issue explores how digital transformation is reshaping regulated industries, highlighting…
May / June 2026
This issue explores the evolving landscape of Advanced Therapy Medicinal Products (ATMPs), examining…
