Introduction to GMP Automation Projects
This manual provides essential guidelines for system users and configuration engineers involved in integrating SIMATIC systems into a Good Manufacturing Practice (GMP) environment. It covers critical aspects of validation and addresses the specific requirements set forth by international regulatory bodies and organizations, including 21 CFR Part 11 of the FDA and EU GMP Guide Annex 11.
The document outlines the necessary computer system, software, and configuration procedures from a pharmaceutical and regulatory perspective within a GMP context. Practical examples are used throughout the chapters to illustrate the relationship between requirements and their implementation.
Target Audience and Knowledge
This manual is designed for plant operators, system design specialists, project managers, programmers, and maintenance personnel working with automation and process control technology in GMP environments. Basic knowledge of SIMATIC WinCC is recommended, and familiarity with GMP practices in the pharmaceutical industry is advantageous.
Key Topics Covered
- Configuring systems within a GMP environment
- Requirements for computer systems in GMP
- System specifications and hardware/software selection
- System installation and basic configuration
- Project settings, definitions, and application software creation
- Support for verification, data backup, and system updates
- Operation, maintenance, and servicing procedures
Resources and Support
For further technical documentation and information on SIMATIC HMI products, visit the Siemens industry support website: SIMATIC HMI technical documentation.
Information on Siemens products, systems, and services for the pharmaceutical industry can be found at: Siemens Pharma Solutions.
For technical support, please refer to: Siemens Technical Support.
