Training contents

Part 1: introduction to pharmaceutical utilities

In the first part of this online training you learn what the most important utilities are in pharmaceutical GMP production: WFI, PW, black and clean steam, compressed air and other process gases.

Part 2: GMP requirements

In this extensive second part of the training you learn what is required according to the European and US FDA GMP guidelines and the pharmacopeia (USP, EP). You learn what the legal limits are on pharmaceutical water, steam and process gas systems.

Part 3: design considerations

In this part you learn how to design a system which can consistently produce, store and distribute a pharmaceutical utility such as WFI, PW or clean steam. Covers critical design elements and many examples, such as P&ID's of distribution networks, contact materials and instrumentation.

Part 4: commissioning & qualification

This section covers the writing of URS, commissioning and qualification up to PQ. You learn about the required validation documentation as well as the actual user requirements, and the C&Q tests needed on different pharmaceutical utilities.

Part 5: routine operations

To maintain the qualified state of a pharmaceutical utility a whole set of operational processes must be in place. In this last part of the online training you get a high-level introduction to monitoring, change control, and other key processes required by the GMP regulations.