PRACTICE 1: GMP-COMPLIANT DOCUMENTATION
Inspections mostly do not take place on-site but in the office. Processes, standard documents, and their compliance are checked through documents. This also applies to the technical area. In this practical exercise, you will learn to identify errors in technical GMP documents and how to avoid them.

 

 

PRACTICE 2: FACILITY DESIGN
The GMP-compliant design of a production facility is the focus of the second practical part. Using an example, you will learn how to design a facility for a given process flow or how to correct it during FAT and critically assess costs.

 

 

PRACTICE 3: IMPACT ASSESSMENT
For each process chain, it is necessary to identify systems with a quality impact and specify the corresponding validation steps. In this practical part, you will gain insight into typical equipment lists from pharmaceutical manufacturing areas and see how a systematic assessment of equipment can be carried out. Key here: the quality impact. Based on the results, appropriate qualification/validation strategies can later be established.

 

PRACTICE 4: USER REQUIREMENT SPECIFICATION (URS) / RISK ANALYSIS
Risk analysis is the central element in planning a facility and becomes a key guide in qualification. In the fourth practical part, user requirements (URS) are established, and based on this, the creation of a risk analysis is explained.