{"id":43965,"date":"2022-11-22T14:18:13","date_gmt":"2022-11-22T07:18:13","guid":{"rendered":"https:\/\/techmaster.com.vn\/?page_id=43965"},"modified":"2022-11-22T14:23:57","modified_gmt":"2022-11-22T07:23:57","slug":"review-of-annex-1-2022-environmental-monitoring-changes","status":"publish","type":"page","link":"https:\/\/techmaster.com.vn\/en\/review-of-annex-1-2022-environmental-monitoring-changes\/","title":{"rendered":"Review of Annex 1 2022: Environmental Monitoring Changes"},"content":{"rendered":"\n\t<section class=\"section\" id=\"section_300692381\">\n\t\t<div class=\"bg section-bg fill bg-fill  \" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-216272411\">\n\n\n\t<div id=\"col-859498768\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<div id=\"text-2800025015\" class=\"text\">\n\t\t\n\n<h2 class=\"banner-title\" style=\"text-align: left;\">Application Note<\/h2>\n\t\t\n<style>\n#text-2800025015 {\n  font-size: 1.6rem;\n  line-height: 1.75;\n  color: rgb(255,255,255);\n}\n#text-2800025015 > * {\n  color: rgb(255,255,255);\n}\n<\/style>\n\t<\/div>\n\t\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-859498768 > .col-inner {\n  padding: 0px 0px 0px 40px;\n  margin: -5px 0px -60px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_300692381 {\n  padding-top: 40px;\n  padding-bottom: 40px;\n}\n#section_300692381 .section-bg.bg-loaded {\n  background-image: url(https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/07\/banner-knowledge.jpeg);\n}\n#section_300692381 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_300692381 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t\n\t<section class=\"section\" id=\"section_1618526369\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-1566814550\">\n\n\n\t<div id=\"col-1019755229\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h2><span data-text-color=\"alert\">Introduction \u2013 Review of Annex 1 2022: Environmental Monitoring Changes<\/span><\/h2>\n<p>In August 2022, a new revision of the EU GMP Annex 1 regulatory standard for sterile drug products was released, replacing the most recent draft from 2020 and the existing revision from 2008. The deadline for operational use of the new standards is August 25, 2023: a year after the release. These requirements regulate the manufacturing of sterile drugs made in and imported to the EU. Pharmaceutical manufacturing is performed in controlled environments to reduce contamination and changes recently announced by Annex 1 focus more on strategic control than on measurement of quality. This new revision also better aligns the manufacturing principles contained in Annex 1 to those presented by the World Health Organization (WHO), Pharmaceutical Inspection Cooperation Scheme (PIC\/S), and US Food and Drug Administration (FDA).<\/p>\n<p>The new revision is a complete rewrite of the existing Annex 1 from 2008 and almost quadruples the length. It divides the document into 10 newly defined sections. One major sectioning change is the separation and differentiation of Certification (Section 4) and Monitoring (Section 9), which allows for expanded guidance and distinction between premise design\/qualification and ongoing routine monitoring. There is a new section that discusses the concept of contamination control strategy (CCS). This section shifts to a new paradigm of incorporating CCS as a central holistic approach to how each aspect of contamination interacts with the facility as a whole. There is also a new section that discusses and identifies Quality Risk Management (QRM) as a central principle for defining processes, operations, and limits, and it ties to CCS to balance processes against risk. Additionally, as laid out in the new revision, regulations for Environmental Monitoring are essentially the same with a few enhanced descriptions to better align with QRM.<\/p>\n<p style=\"text-align: center;\"><strong>Complete the form to the right to access the full paper and learn more about these changes.\u00a0<\/strong><\/p>\n<p>Or, join our\u00a0<span data-text-color=\"alert\">Annex 1 webinar<\/span>\u00a0and have your questions answered.<\/p>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1626206942\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h2><span data-text-color=\"alert\"><strong>Annex 1 Continuous Environmental Monitoring Solutions<\/strong><\/span><\/h2>\n<h3><span data-text-color=\"alert\"><strong>Viable Environmental Monitoring:<\/strong><\/span><\/h3>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1773329436\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<p><span data-text-color=\"alert\"><em>Microbial Air Sampler: MiniCapt\u00ae Mobile<\/em><\/span><\/p>\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_126524400\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"400\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/MiniCapt-Mobile-Compliant-400x400-1.jpeg\" class=\"attachment-large size-large\" alt=\"MiniCapt Mobile Compliant\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_126524400 {\n  width: 80%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1010967207\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-393017353\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<p><span data-text-color=\"alert\"><em>Microbial Monitor: BioCapt\u00ae Single-Use<\/em><\/span><\/p>\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_1439905569\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"400\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/BioCapt-SU-Compliant-400x400-1.jpeg\" class=\"attachment-large size-large\" alt=\"BioCapt SU Compliant\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_1439905569 {\n  width: 80%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-977507636\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1985433226\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<p><span data-text-color=\"alert\"><em>Remote Air Sampler: MiniCapt\u00ae<\/em><\/span><\/p>\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_483409508\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"400\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/MiniCapt-Remote-Compliant-400x400-1.jpeg\" class=\"attachment-large size-large\" alt=\"MiniCapt Remote Compliant\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_483409508 {\n  width: 80%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-492743525\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-722198211\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h3><span data-text-color=\"alert\"><strong>Nonviable Environmental Monitoring:<\/strong><\/span><\/h3>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-946356126\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<p><span data-text-color=\"alert\"><em>Remote Particle Counter: IsoAir\u00ae Pro-Plus<\/em><\/span><\/p>\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_27353457\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"400\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/IsoAir-Pro-Plus-Compliant-400x400-1.jpeg\" class=\"attachment-large size-large\" alt=\"IsoAir Pro Plus Compliant\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_27353457 {\n  width: 80%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1120457503\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-642397532\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<p><span data-text-color=\"alert\"><em>Airborne Particle Counter: Lasair\u00ae Pro<\/em><\/span><\/p>\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_7848641\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"400\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/Lasair.-Pro-Compliant-400x400-1.jpg\" class=\"attachment-large size-large\" alt=\"Lasair Pro Compliant\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_7848641 {\n  width: 80%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1167079233\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-883527321\" class=\"col medium-4 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<p><span data-text-color=\"alert\"><em>Airnet\u00ae II \/ IIs Remote Particle Sensors (2 Channels)<\/em><\/span><\/p>\n\t<div class=\"img has-hover x md-x lg-x y md-y lg-y\" id=\"image_764040554\">\n\t\t\t\t\t\t\t\t<div class=\"img-inner dark\" >\n\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"400\" src=\"https:\/\/techmaster.com.vn\/wp-content\/uploads\/2022\/11\/Airnet-II-Compliant-1-400x400-1.jpeg\" class=\"attachment-large size-large\" alt=\"Airnet II Compliant 1\" \/>\t\t\t\t\t\t\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n<style>\n#image_764040554 {\n  width: 80%;\n}\n<\/style>\n\t<\/div>\n\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1962497432\" class=\"col medium-8 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1618526369 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_1618526369 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_1618526369 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n\t<\/section>\n\t\n\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":11,"featured_media":43971,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-43965","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Review of Annex 1 2022: Environmental Monitoring Changes - Techmaster Electronics 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