risk assessment Archives - Particle Measuring Systems

Cleanroom Process Risk Assessment per Annex 1

Nina Morton — Fri, 01 May 2020 06:45:39 +0000

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...

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Viable and Non Viable Particle Counts

Nina Morton — Tue, 28 Apr 2020 06:22:09 +0000

Environmental and Process Monitoring- Annex 1, Section 9.4 In Part 3 of our 5 part blog series, we look at Viable Non Viable (V/NV ) Particle counts regarding Environmental and Process Monitoring as found in Annex 1, Section 9.4: RA should be done to develop a comprehensive environmental monitoring program...

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Quality Risk Management Principles in Annex 1, Section 2

Nina Morton — Wed, 29 Apr 2020 15:12:49 +0000

The use of Quality Risk Management (QRM) principles and risk-based approaches are prominent expectations throughout the Annex 1 draft. Risk-based approaches are mentioned 43 times in the draft reinforcing the importance of using Risk Based approaches in all aspects of sterile product manufacturing. Here we highlight requirements related to Quality...

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