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
Oct 23, 2024
Quality
Active Pharmaceutical Ingredients
Good Manufacturing Practice
Jun 13, 2024
Information Systems
Regulatory
Advanced Manufacturing
Active Pharmaceutical Ingredients
Apr 12, 2024
Quality by Design
Pharmaceutical Engineering Magazine Articles
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)…
Continuous Process: Implementing Low pH Viral Inactivation in a Continuous Process
Viral inactivation (VI) is a critical step in ensuring the safety of monoclonal antibody (mAb), Fc…
Material Properties Databases to Advance Pharmaceutical Processing
Pharmaceutical manufacturers rely heavily on powder processes, the majority of which are designed…
Biopharma Facility Design: Lessons Learned on the Dance Floor
In 2014, Pharmaceutical Engineering® published an article, “ Lessons Learned in the Ballroom,”…
Webinars
Videos
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
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
July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
March / April 2024
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific…
