An established microbial or airborne particle level giving early warning of potential drift from normal operating conditions and triggers appropriate scrutiny and follow up to address the potential problem. Alert levels are always lower than action levels and are established based on historical and qualification trend data and periodically reviewed.
Source: GMP Draft Annex 1
DQ IQ OQ PQ
Validation protocols are a method of establishing documented evidence that shows a high degree of as...Read more
Validation Frequency Requirements
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Cleanroom installation by Connect 2 Cleanrooms is performed by a trained, competent and experienced...Read more