Cleanroom Qualification – Classification – Monitoring Per EU GMP Annex 1, rev 12 draft

The definition for Cleanroom Qualification is “The overall process to assess the level of compliance of a classified cleanroom with its intended use.” That is, classification is a part of qualification.

Qualification methodologies are identified in EU GMP Annex 15 and all verification must comply with the testing methodologies in ISO 14644-3:2019.

Qualification Verification

The next item to consider is which verifications are needed for cleanroom classification?

First, it is important to understand that microbial contamination for airborne and surface must be measured both “at-rest” and “in-operation” states.

Next, the number and location of sampling points should be based on a documented risk assessment. This is not the same RA for microbial monitoring. This RA is to create a microbial map that characterizes the cleanroom.

 Re-qualification

Re-qualification must be carried out as a minimum following these timelines:

• A & B: at least every 6 months
• C & D: at least every 12 months

The new Annex draft also specifies the re-qualification tests needed, and that after changes or an extraordinary event, the cleanroom must be re-qualified.

 Learn how our Advisory Services Team can help you with your cleanroom classification and qualification.