All companies have a reason for existing and a focus on what they do best. That is why most companies bring in experts to partner with for areas outside their expertise. Particle Measuring Systems (PMS) partners with companies, such as pharmaceutical manufacturers, to ensure they have the best complete contamination…
Data Trending and Alert/Action Levels definition are new requirements in the latest EU GMP Annex 1, Revision 12 draft. Trends allow you to quickly and easily identify changes in your cleanroom data and leverage this to make effective decisions, changes, and adjustments often before problems occur. Here we discuss three…
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 –Ā Classification ā Monitoring Per EU GMP Annex 1, rev 12 draft The definition for Cleanroom Qualification is āThe overall process to assess the level of compliance of a classified cleanroom with its intended use.ā That is, classification is a part of qualification. Qualification methodologies are identified in EU…