microbial monitoring Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/microbial-monitoring/ Contamination control instruments and expertise Mon, 29 Jul 2024 14:35:15 +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 microbial monitoring Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/microbial-monitoring/ 32 32 USP 797 Updates https://www.pmeasuring.com/usp-797-updates/ Thu, 30 Nov 2023 18:01:38 +0000 https://www.pmeasuring.com/?p=137505 The most recent revision to USP 797 brings forth changes that touch various aspects of pharmaceutical practices. Here, we explore the USP Regulatory Standards Development Process.

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]]> Cleanroom Monitoring System per Annex 1 draft https://www.pmeasuring.com/cleanroom-monitoring-annex-1/ Tue, 19 May 2020 05:49:20 +0000 https://www.pmeasuring.com/?p=65782 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...

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]]> Quality Risk Management in Annex 1; 6.1 https://www.pmeasuring.com/quality-risk-management-in-annex-1-6-1-3/ Wed, 29 Apr 2020 15:17:53 +0000 https://www.pmeasuring.com/blog/quality-risk-management-in-annex-1-6-1/ 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. In part 2 of our five-part series,...

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