Topic Block 1: Fundamentals
The importance of maintenance is increasing both economically and as a sub-aspect of GMP-compliant manufacturing. Guidance is provided for technically responsible personnel, based on regulatory frameworks. The implementation of these frameworks into a "liveable" practice will be presented during the lecture.

Topic Block 2: Approach to Maintenance
From the start of a project, future maintenance measures must be planned (e.g., accessibility of a facility). During the project, aspects such as maintenance intervals and spare parts inventory must be discussed and decided. This also has significant cost implications. For a finished, operational facility, maintenance measures should follow established rules.

Topic Block 3: Practical Examples
GMP-compliant maintenance requires systems that maintain documented qualified equipment status throughout the entire usage period. This can be achieved in various ways. The lectures present a practiced maintenance process through which all maintenance activities are evaluated, categorized, and documented under GMP considerations.

Topic Block 4: IT Support
The specific requirements in the pharmaceutical environment and the resulting challenges regarding data collection, structuring, documentation, and integrity can be addressed and managed with IT solutions. The information generated from an IT-supported maintenance process can be used for plant optimization as well as for troubleshooting documentation. Particularly, integration with other GMP interfaces such as change control and deviation management is of governmental interest.