Part 2 of 3 part blog on : Cleanroom Classification – Qualification – 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.
Want to read more? Read our other posts in this series:
- Part 1 of 3, May 8, 2020: Cleanroom Classification
- Part 2 of 3, May 13, 2020: Cleanroom Qualification (you are here!)
- Part 3 of 3, May 19, 2020 Cleanroom Monitoring
See links to additional supporting resources below:
- Paper: Choosing the Most Suitable Particle Sample Point Locations in the Cleanroom
- Video: Cleanroom Monitoring Updates Discussion
- Blog: How to Achieve Quality by Design (QbD) in a new Pharmaceutical Fill Line
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