quality risk management Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/quality-risk-management-sg/ Contamination control instruments and expertise Tue, 13 Aug 2024 17:58:59 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 https://www.pmeasuring.com/wp-content/uploads/2018/12/cropped-pms-icon-1-150x150.png quality risk management Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/quality-risk-management-sg/ 32 32 Cleanroom Contamination Sources https://www.pmeasuring.com/cleanroom-contamination-sources/ Wed, 30 Jun 2021 15:00:30 +0000 https://www.pmeasuring.com/?p=98920 In our previous blog in this series, we introduced you to the contamination control strategy (CCS), and why you need one. This time, we look at the quality risk management approach to preparing the CCS in order to design the ideal cleanroom for your Pharma process.

The post Cleanroom Contamination Sources appeared first on Particle Measuring Systems.

]]> Cleanroom Process Risk Assessment per Annex 1 https://www.pmeasuring.com/cleanroom-process-risk-assessment-annex-1/ Fri, 01 May 2020 06:45:39 +0000 https://www.pmeasuring.com/?p=65617 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...

The post Cleanroom Process Risk Assessment per Annex 1 appeared first on Particle Measuring Systems.

]]> Viable and Non Viable Particle Counts https://www.pmeasuring.com/viable-non-viable-particle-counts/ Tue, 28 Apr 2020 06:22:09 +0000 https://www.pmeasuring.com/?p=65589 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...

The post Viable and Non Viable Particle Counts appeared first on Particle Measuring Systems.

]]> Quality Risk Management Principles in Annex 1, Section 2 https://www.pmeasuring.com/quality-risk-management-principles-in-annex-1-section-2/ Wed, 29 Apr 2020 15:12:49 +0000 https://www.pmeasuring.com/blog/quality-risk-management-principles-in-annex-1-section-2/ 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...

The post Quality Risk Management Principles in Annex 1, Section 2 appeared first on Particle Measuring Systems.

]]>