Pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and control based on sound science and quality risk management.
iSpeak Blog
Process Intensification, Continuous Manufacturing, and Sustainability
Biotech companies are meeting modern sustainability objectives and gaining a competitive advantage…
iSpeak Blog
New ISPE Good Practice Guide Helps Pave the Way to Digital Validation
In 2023, the ISPE Commissioning and Qualification (C&Q) Community of Practice (CoP) conducted a…
Video
QRM Based Integrated C&Q Series - Engineering Change Management
QRM Based Integrated C&Q Series - Engineering Change Management Complimentary Learning Level…
Product
Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (Third Edition)
Published: December 2024 Pages: 122 Table of Contents Special Pricing for Emerging Economies This…
iSpeak Blog
Disaster Recovery in the Pharmaceutical Industry: Lessons Learned from Conflict and Catastrophe
In the pharmaceutical industry, disaster recovery is not just about protecting business continuity…
Product
Good Practice Guide: Digital Validation
Published: April 2025 Pages: 90 Table of Contents Special Pricing for Emerging Economies This Guide…
Video
QRM Based Integrated C&Q Series - Good Engineering Practices as a Key Enabler for Integrated C&Q
QRM Based Integrated C&Q Series - Good Engineering Practices as a Key Enabler for Integrated C&Q…
Video
Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
This third edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends…
iSpeak Blog
ISPE Members Continue Training Health Authorities on ICH Q12 Implementation
ISPE’s Q12 Implementation team, a working group under the auspices of ISPE's Product Quality…
Video
Navigating the PFAS Challenge in Pharma: Regulatory Landscape, Risk Management, and Health Implications
Complimentary Learning Level: Intermediate Session Length: 1 hour Per- and polyfluoroalkyl…
iSpeak Blog
Sustainability Track – Building a Sustainable Future: A Pharmaceutical Engineering Perspective
The 2025 ISPE Europe Annual Conference, taking place 12-14 May in London, United Kingdom, will…
Guidance Documents
Commissioning & Qualification (1)
Lifecycle Management (2)
Microbiological & Viral Contamination Control (1)
Process Analytical Technology (2)
Quality by Design (5)
- 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
Community Discussions
Community Discussions
Apr 16, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Dec 04, 2024
GAMP®
Lifecycle Management
Oct 23, 2024
Quality
Active Pharmaceutical Ingredients
Good Manufacturing Practice
Pharmaceutical Engineering Magazine Articles
Removing the Frustration from Functional Risk Management
Risk assessment is essential, however, risk assessment is of limited value if it is not conducted by…
A GAMP® Approach to Computerized System Life Cycle and IT Process Records
This article describes a practical and pragmatic approach to the management of computerized system…
Embracing the Unknown: QRM Strategies for Cell and Gene Therapies Facilities
The pharmaceutical landscape is rapidly evolving, and cell and gene therapies (C>) are at the…
Experts Create Examples of C&Q Deliverables
In 2019, ISPE released the Second Edition of the ISPE Baseline® Guide Vol 5: Commissioning and…
In-Silico Data-Driven Mechanistic Model–Assisted Process Validation
The US Food and Drug Administration (FDA) advocates for the integration of quality by design (QbD)…
Benefits and Challenges of Process Capability Metrics
Process capability is a fundamental concept for manufacturers. Pharmaceutical, biopharmaceutical…
ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma
ChatGPT and other large language models are positioned to change the world. They can also shift…
A Systemwide Approach to Managing the Risks of Continuous Manufacturing
Understanding and managing risks to continuous manufacturing (CM) technology is central to any…
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification…
A Proposal for a Comprehensive Quality Overall Summary
When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope…
ISPE Briefs: New Guide Promotes Cultural Excellence
Cultural excellence is the expressed and implied ways in which an organization operates. Excellence…
Why QbD and Digitalization Are Foundations for Cell Therapies
An interview with Shin Kawamata of Japan’s Foundation for Biomedical Research and Innovation (FBRI)…
Webinars
Videos
Video
Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
This third edition of the ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends…
Video
QRM Based Integrated C&Q Series - New Program Initiation, Objections, Audit Defense
QRM Based Integrated C&Q Series - New Program Initiation, Objections, Audit Defense Complimentary…
Video
QRM Based Integrated C&Q Series - Implementing a Science and Risk Based Approach to Commissioning & Qualification
QRM Based Integrated C&Q Series - Implementing a Science and Risk Based Approach to Commissioning &…
Video
Advance Biopharma Tech Transfer Using Process Modeling & Simulation Webinar
Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour While biotherapeutics is one…
Video
ISPE Expert Xchange GAMP®: Implementing Data Integrity by Design
ISPE Expert Xchange is a new interactive, collaborative experience that unites forward-thinking…
iSpeak Blog Posts
Professional Development Training
ICH Q8: QbD in Manufacturing
The ICH Q8 guideline ensures a systematic approach to pharmaceutical development by defining globally recognized Quality by Design (QbD) principles to enhance product quality throughout all stages of development.
ICH Q10: Pharmaceutical Quality System (PQS)
The Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products. Overview This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures product quality meets established standards throughout the lifecycle of pharmaceutical products. It aims for suitable process performance by implementing robust controls for drug development and manufacturing, including quality assurance, risk management, and regulatory compliance. The system identifies…
First Principles to Improve Pharma Manufacturing Operations Training Course
This course will show how First Principles-based approaches will provide a valuable tool to help create such control strategies. Drawing on examples from over 30 years’ experience in the pharma industry, the attendees will see what First Principles are and how not using a First Principle approach can lead to poor problem solving and even significant disasters.
Process Validation Training Course
This training course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System.
Turning Quality by Design (QbD) into a Practical Reality Training Course
Through group exercises, this course on Quality by Design will delve into implementation and operation of an effective and efficient control strategy in manufacturing, which is a key element of process performance and product quality monitoring and continual improvement.
Facilities Management Training Course
This interactive course will provide the learner with tools on how to implement a sustainable approach to a risk-based C&Q program, integrate the new C&Q program into existing quality systems, Quality Assurance and Engineering Management Systems and define organizational capabilities to support the new C&Q program.
White Papers
March / April 2025
A Skill Management Framework for a Pharma 4.0™ Workforce Feature: Pharma 4.0™ is driving fundamental…
January / February 2025
GAMP® is indispensable for safeguarding the safety, quality, and compliance of pharmaceutical…
November / December 2024
Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a…
