Process Analytical Technology (PAT) and lifecycle control strategy are umbrella terms covering a range of essential components for other innovative initiatives, such as quality by design, real-time release, and continuous manufacturing.
Good Practice Guide: Continuous Manufacturing of Biological Products
Published: December 2025 Pages: 200 Table of Contents Special Pricing for Emerging Economies…
Efficient and Reliable C&Q of Water and Steam Systems
Water and steam are essential in the pharmaceutical industry. Both are used for multiple purposes…
Newly published ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing (CM) of Solid Dosage Forms (OSD) Helps Support Broader Adoption of CM
Continuous manufacturing (CM) of oral solid dosage forms has become a well-established approach that…
Good Practice Guide: Control Strategy Development for CM of OSD Forms
Published: October 2025 Pages: 72 Table of Contents Special Pricing for Emerging Economies…
Good Practice Guide: C&Q of Water & Steam Systems 3rd Edition
Published: September 2025 Pages: 124 Table of Contents Special Pricing for Emerging Economies Water…
Validation 4.0 for the Pharmaceutical Industry
The pharmaceutical industry is under increasing pressure to develop new therapies at a faster pace…
Good Practice Guide: Validation 4.0
The Validation 4.0 Guide provides a comprehensive approach to ensuring product quality and patient…
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes Extended Learning Learning…
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
Process Validation in Context of Small Molecule DS and DP Continuous Manufacturing Processes
This Discussion Paper discusses considerations for process validation (PV) activities with a…
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration Complimentary Learning Level…
Acing an Audit: What to Do Before, During, and after an Inspection
Acing an Audit: What to Do Before, During, and after an Inspection Learning Level: Basic Session…
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Guidance Documents
Biotechnology (1)
Commissioning & Qualification (1)
Critical Utilities (1)
Knowledge Management (1)
Lifecycle Management (3)
Manufacturing Operations (2)
Oral Solid Dosage (1)
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
Quality by Design (3)
Validation (1)
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iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
Efficient and Reliable C&Q of Water and Steam Systems
Water and steam are essential in the pharmaceutical industry. Both are used for multiple purposes…
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification…
Communities of Practice Profiles: Meet the PAT-LCS CoP
ISPE has more than 17 global Communities of Practice (CoPs) where members can connect with each…
Analyzing System Performance through Process Instrumentation Data
What if the reliability of a system could be improved by accessing the standard data provided with…
Quality & Regulatory Solutions for PAT in Continuous Manufacturing
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy…
Videos
Professional Development Training
Quality Risk Management (QRM) Workshop Training Course
This interactive advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments.
Implementing Process Analytical Technology Training Course
This course is designed to help pharmaceutical manufacturing professionals chart a new course for innovation based on PAT. The course provides an overview to the tools and principles outlined in the FDA guidance, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance.
GAMP® 5 GxP Process Control Training Course
This highly interactive classroom course describes how the GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Process Control Systems, and GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records may be applied to achieve process control systems that are fit for intended use, incorporate data integrity and meet current regulatory requirements.
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…
