GMP for Beginners in Sterile Manufacturing

Understanding and applying GMP regulations is fundamental to the manufacture of medicinal products and medical devices. Particularly in the manufacture of sterile medicinal products, employees have to comply with extensive requirements. Against this background, employees have to know the GMP requirements and must know how to use them in practice.

The question is: How can employees implement in their daily work regulations which are usually formulated in a very general manner?

Against this background, the Online Training has been designed for personnel working in sterile manufacturing who wish to build or strengthen their basic GMP knowledge. It introduces the most important pharmaceutical regulations governing sterile production and explains their relevance in everyday operations. Participants receive a structured overview of general GMP principles, as well as the specific requirements applicable to sterile manufacturing. The course also familiarises participants with the key processes in sterile pharmaceutical production.

To support the practical application of theory in everyday work, the training addresses common situations that employees encounter, such as correct cleaning and disinfection procedures, appropriate behaviour in clean rooms, entering clean room areas, environmental monitoring activities, and performing media fills.

The overall aim of the Online Training is to enable participants to understand regulatory expectations and to implement them confidently and pragmatically in their daily work in sterile manufacturing Environments.

Process Simulation / Media Fills

During this course, you will learn through lectures and workshops:

– the new requirements of the revised EU Annex 1,
– how to plan a media fill in compliance with European and US GMP requirements,
– how to interpret the results of a media fill,
– how to investigate deviations and define appropriate follow-up measures, and
– how Quality Assurance (QA) should be involved.