Sampling standards keep managers of environmental monitoring (EM) on their toes. Read this blog to learn more about how to use high flowrate monitoring to make the most out of your EM practices in less time.
The new EU GMP Annex 1 specifies the requirements of a pharmaceutical risk assessment to set appropriate microbiological plate conditions. This blog discusses this requirement to use a risk assessment, and then provides an interpretation on how to apply it and use it in different stages of the manufacturing process….
Cleanroom Monitoring v. Classification v. Cleanroom Qualification Per EU GMP Annex 1, rev 12 draft There is little overlap with cleanroom monitoring and qualification and classification as seen in the image here: The goal of a cleanroom monitoring system is to assess the potential contamination risk of the product. The…
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…
