gmp Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/gmp/ Contamination control instruments and expertise Mon, 06 Nov 2023 16:40:55 +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 gmp Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/gmp/ 32 32 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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]]> Cleanroom Qualification https://www.pmeasuring.com/cleanroom-qualification/ Tue, 12 May 2020 06:18:29 +0000 https://www.pmeasuring.com/?p=65715 Cleanroom Qualification – Classification – Monitoring Per EU GMP Annex 1, rev 12 draft The definition for Cleanroom Qualification is “The overall process to assess the level of compliance of a classified cleanroom with its intended use.” That is, classification is a part of qualification. Qualification methodologies are identified in EU...

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]]> Cleanroom Classification https://www.pmeasuring.com/cleanroom-classification/ Fri, 08 May 2020 06:08:25 +0000 https://www.pmeasuring.com/?p=65646 Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft The latest EU GMP Annex 1 draft has some new definitions and guidance regarding Cleanroom Classification, Qualification, and Monitoring. Cleanroom Classification Annex 1 provides essentially the same cleanroom classification definition as ISO 14644-1: 2015 which is...

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]]> Potential Cleanroom Sampling Points per Annex 1 Draft https://www.pmeasuring.com/cleanroom-sampling-points-annex-1/ Thu, 30 Apr 2020 06:33:28 +0000 https://www.pmeasuring.com/?p=65594 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...

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]]> 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...

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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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