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…
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….
In the final part of our five part series of Quality Risk Management per Annex 1, we explore the benefits of a Cleanroom Process Risk Assessment and how our Contamination Control Advisers can provide you with one. Cleanroom Process Risk Assessment: Why it’s important A process risk assessment helps you…
EU GMP Annex 1 provides guidance on choosing effective cleanroom sampling points. Definition: Cleanroom Sample points include particle counters and microbial monitors. Identification of critical areas by HACCP analysis and process understanding Choose points within the critical areas according to defined criteria When performed this way, you can demonstrate a…