Since the COVID-19 pandemic, the life sciences industry has seen a push to bring system validation onto a single, computerized system that manages validation, design and testing. With the recently released ISPE GAMP® Good Practice Guide: GxP Process Control Systems (Third Edition), ISPE intends to provide organizations the best‑practice strategies to help them achieve Process Control Systems (PCSs) fit for intended use and compliant with regulations in a cost-effective manner.
The Guide presents a cost-effective framework and examples for applying ISPE GAMP® 5 to a wide range of GxP-regulated process control systems and offers guidance on the development and maintenance of process control systems (PCSs). In particular, it is designed to fill the gap that has traditionally existed between commissioning and qualification and computer systems validation.
To help structure this complexity, PCSs are often considered in three broad forms:
- Process control devices
- Control systems embedded within packaged process equipment
- Control systems developed independently of the equipment they control
Compared with other system types, process control systems tend to have more components of different types, often supplied by multiple vendors. Each added component and supplier introduces new interfaces, dependencies, and risks. Managing these effectively requires collaboration across engineering, IT, quality, automation, and supplier teams.
“The data side is so important,” notes Hilary Mills-Baker, Chair of the United Kingdom GAMP Community of Practice and Guide Co-Lead. “The data that we are collecting from the shop floor has to filter up into other systems and still has to be true because every time it is moved, mistakes can be made. We’re trying to make it clear to people how you manage to do this. We want to show them what the risks are, where the problems are.”
To shed more light on these risks, the Guide includes new examples for managing data integrity risks, as well as product manufacturing risks.
In addition to a strong focus on data integrity, it addresses technological advances in modular plant design, cloud and software-as-a-service integration, software development tools, artificial intelligence, and operational technology cybersecurity. Updated content covers:
- Modular plants, modular systems, and plug and produce
- Software tools and project execution tools
- Low-risk/low-complexity systems
- Cloud and SaaS interfaces
- Pharma 4.0™
- Continuous manufacturing
- Medical device production
- Personalized medicine
- Use of artificial intelligence
- Operational technology cybersecurity
- Computerized system validation and C&Q integration
The Guide also strengthens the connection between PCSs and the process equipment activities defined in the ISPE Baseline® Guide: Commissioning and Qualification (Second Edition), providing a more holistic, streamlined roadmap from design to operation.