04.09.2023

When is qualification required for rooms and air handling units and when is technical acceptance testing sufficient?

The qualification should be limited to aspects and parameters which have significant impact to product and personal safety according to the risk assessment; for all others, which are required for proper technical functioning of the premises and air handling units, technical acceptance testing according to GEP is sufficient.

[GMP Compliance Adviser, Chapter 3.J]


 

You can find out more about this topic:


The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business!