RA Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/ra-sg/ Contamination control instruments and expertise Sun, 20 Aug 2023 16:04:28 +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 RA Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/ra-sg/ 32 32 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...

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