Classification, Qualification And Monitoring According To EU GMP Annex 1 Rev 12

By Maurizio Della Pietra, Product Line Manager, Life Sciences Division

Annex 1 provides essentially the same cleanroom classification definition as ISO 14644-1: 2015, which is a “method of assessing the level of cleanliness against a regulatory specification for a cleanroom or clean zone.” Annex 1 also defers to ISO 14644-1:2015 definitions for the various cleanroom standards and specifications. In Annex 1, Revision 12, nothing has changed regarding the association between pharmaceutical grades and the ISO classes:

• Grade A and B cleanrooms must comply with the ISO 5 requirements in at-rest occupancy state.
• Grade C cleanrooms must comply with ISO 7.
• Grade D cleanrooms must comply with ISO 8.

Continue reading to learn more about the latest Annex 1 draft which includes some new definitions and guidance regarding cleanroom classification, qualification, and monitoring.