30.09.2024

Where can you find regulatory requirements for isolator technology?

The statutory requirements that apply to isolator technology can be found in Annex 1 of the EU GMP Guidelines, in the FDA guidelines on the manufacturing of sterile drug products as well as in EN ISO 14644-7.

[GMP Compliance Adviser, Chapter 3.F]


 

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!