annex 1 Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/annex-1-es/ Contamination control instruments and expertise Tue, 13 Aug 2024 19:29:38 +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 annex 1 Archives - Particle Measuring Systems https://www.pmeasuring.com/tag/annex-1-es/ 32 32 Data Analytics in Pharmaceutical Manufacturing https://www.pmeasuring.com/pharmaceutical-manufacturing-data-management-environmental-monitoring/ Mon, 29 Jan 2024 18:22:39 +0000 https://www.pmeasuring.com/?p=138134 What Cleanroom Data Analytics in Pharmaceutical Manufacturing Should be Considered When Setting up Environmental Monitoring? Pharmaceutical Manufacturing Data Analytics and Managment is one of the important steps for effective contamination control In a typical pharmaceutical manufacturing plant, there are several important tasks to ensure the product can be handled without...

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]]> EU GMP Guidelines for Environmental Monitoring: Questions and Answers https://www.pmeasuring.com/eu-gmp-annex-1-faqs-environmental-monitoring/ Tue, 02 Jan 2024 23:50:04 +0000 https://www.pmeasuring.com/?p=137866 Answers to EU GMP Annex 1 FAQs and concerns on the topic of environmental monitoring.

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]]> EU GMP Annex 1 Airflow Questions and Answers https://www.pmeasuring.com/eu-gmp-annex-1-air-speed-strategies-for-unidirectional-flows-faqs/ Tue, 02 Jan 2024 23:05:40 +0000 https://www.pmeasuring.com/?p=137896 Answers to EU GMP Annex 1 FAQs and concerns on the topic of air speed strategies for unidirectional flows.

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]]> EU GMP Annex 1 – Commonly Asked Questions https://www.pmeasuring.com/eu-gmp-annex-1-commonly-asked-questions/ Tue, 13 Jun 2023 19:05:48 +0000 https://www.pmeasuring.com/?p=131941 Welcome to our EU GMP Annex 1 questions and answers blog, where experts answers commonly asked questions about the latest changes to regulation.

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]]> Build the Ideal Contamination Control Strategy CCS https://www.pmeasuring.com/build-the-ideal-contamination-control-strategy/ Wed, 23 Jun 2021 15:00:41 +0000 https://www.pmeasuring.com/?p=98895 The CCS is designed to ensure quality risk management is built into every pharmaceutical process from the ground up, and every quality decision made has a foundation in scientific reasoning.

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]]> CASE STUDY: Sterility Test Isolator viable non viable contamination control solution https://www.pmeasuring.com/pms-and-ems-working-together-to-deliver-a-contamination-control-solution-to-an-austar-customer/ Fri, 04 Jun 2021 13:35:45 +0000 https://www.pmeasuring.com/blog/pms-and-ems-working-together-to-deliver-a-contamination-control-solution-to-an-austar-customer/ In this video interview, the team from AUSTAR UK discuss why and how they worked with Particle Measuring Systems' (PMS) exclusive UK distributor, EMS Particle Solutions, to provide an AUSTAR sterility test isolator customer with a complete viable and non viable particle counting solution using PMS instrumentation and equipment.

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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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]]> 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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]]> 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...

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