{"id":6740,"date":"2023-08-18T19:10:26","date_gmt":"2023-08-18T19:10:26","guid":{"rendered":"podlove-2023-08-18t18:59:21+00:00-a2c037b19dfdff8"},"modified":"2023-08-21T14:08:39","modified_gmt":"2023-08-21T14:08:39","slug":"mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model","status":"publish","type":"podcast","link":"https:\/\/www.truthforhealth.org\/es\/2023\/08\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\/","title":{"rendered":"MHRA Jeopardizes Lives with Safety Oversight Failures in New \u201cPoint of Care\u201d Manufacturing Model"},"content":{"rendered":"\n    \n            <div class=\"podlove-web-player intrinsic-ignore podlove-web-player-loading\" id=\"player-6acd0e1a813f6\"><root data-test=\"player--xl\" style=\"max-width:950px;min-width:260px;\">\n  <div class=\"tablet:px-6 tablet:pt-6 mobile:px-4 mobile:pt-4 flex flex-col\">\n    <div class=\"flex-col items-center mobile:flex tablet:hidden\">\n      <show-title class=\"text-sm\"><\/show-title>\n      <episode-title class=\"text-base mb-2\"><\/episode-title>\n      <subscribe-button class=\"mb-4 mobile:flex tablet:hidden\"><\/subscribe-button>\n      <poster class=\"rounded-sm w-48 shadow overflow-hidden\"><\/poster>\n      <divider class=\"w-full my-6\"><\/divider>\n    <\/div>\n\n    <div class=\"tablet:flex flex-grow\">\n      <div class=\"w-64 mobile:hidden tablet:block tablet:mr-6\">\n        <poster class=\"rounded-sm shadow overflow-hidden\"><\/poster>\n      <\/div>\n      <div class=\"w-full\">\n        <div class=\"hidden tablet:block\">\n          <show-title class=\"text-base\"><\/show-title>\n          <episode-title class=\"text-xl desktop:text-2xl\"><\/episode-title>\n          <divider class=\"w-full my-4\"><\/divider>\n        <\/div>\n        <div class=\"flex items-center justify-between\">\n          <div class=\"block\">\n            <play-state on=\"active\">\n              <speed-control class=\"flex items-center\"><\/speed-control>\n            <\/play-state>\n          <\/div>\n\n          <div class=\"flex\">\n            <play-state on=\"active\">\n              <chapter-previous class=\"mx-2 block\"><\/chapter-previous>\n            <\/play-state>\n            <play-state on=\"active\">\n              <step-backward class=\"mx-2 block\"><\/step-backward>\n            <\/play-state>\n\n            <play-button class=\"mx-2 block\" :label=\"$t('PLAYER.PLAY_EPISODE')\"><\/play-button>\n\n            <play-state on=\"active\">\n              <step-forward class=\"mx-2 block\"><\/step-forward>\n            <\/play-state>\n            <play-state on=\"active\">\n              <chapter-next class=\"mx-2 block\"><\/chapter-next>\n            <\/play-state>\n          <\/div>\n\n          <div class=\"block\">\n            <play-state on=\"active\">\n              <volume-control class=\"flex items-center\"><\/volume-control>\n            <\/play-state>\n          <\/div>\n        <\/div>\n        <div class=\"flex w-full\">\n          <progress-bar><\/progress-bar>\n        <\/div>\n        <div class=\"flex w-full -mt-2\">\n          <div class=\"w-3\/12 text-left\">\n            <timer-current class=\"text-sm\"><\/timer-current>\n          <\/div>\n          <div class=\"w-6\/12 text-center truncate\">\n            <play-state on=\"active\">\n              <current-chapter class=\"text-sm\"><\/current-chapter>\n            <\/play-state>\n          <\/div>\n          <div class=\"w-3\/12 text-right\">\n            <timer-duration class=\"text-sm\"><\/timer-duration>\n          <\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n    <divider class=\"w-full mt-6 mb-3\"><\/divider>\n    <div class=\"flex justify-between\">\n      <div class=\"flex mobile:w-full tablet:w-3\/12 desktop:w-3\/12 justify-between\">\n        <tab-trigger tab=\"chapters\">\n          <icon type=\"chapter\"><\/icon>\n        <\/tab-trigger>\n        <tab-trigger tab=\"transcripts\">\n          <icon type=\"transcripts\"><\/icon>\n        <\/tab-trigger>\n        <tab-trigger tab=\"files\">\n          <icon type=\"download\"><\/icon>\n        <\/tab-trigger>\n        <tab-trigger tab=\"playlist\">\n          <icon type=\"playlist\"><\/icon>\n        <\/tab-trigger>\n        <tab-trigger tab=\"share\">\n          <icon type=\"share\"><\/icon>\n        <\/tab-trigger>\n      <\/div>\n      <subscribe-button class=\"mt-1 mobile:hidden tablet:flex\"><\/subscribe-button>\n    <\/div>\n  <\/div>\n  <div class=\"w-full relative overflow-hidden\">\n    <tab name=\"chapters\">\n      <tab-chapters><\/tab-chapters>\n    <\/tab>\n    <tab name=\"transcripts\">\n      <tab-transcripts><\/tab-transcripts>\n    <\/tab>\n    <tab name=\"files\">\n      <tab-files><\/tab-files>\n    <\/tab>\n    <tab name=\"playlist\">\n      <tab-playlist><\/tab-playlist>\n    <\/tab>\n    <tab name=\"share\">\n      <tab-share><\/tab-share>\n    <\/tab>\n    <tab-overflow><\/tab-overflow>\n  <\/div>\n  <error><\/error>\n<\/root>\n<\/div>\n            <script>\n              document.addEventListener(\"DOMContentLoaded\", function() {\n                var player = document.getElementById(\"player-6acd0e1a813f6\");\n                podlovePlayerCache.add([{\"url\":\"https:\\\/\\\/www.truthforhealth.org\\\/es\\\/wp-json\\\/podlove-web-player\\\/shortcode\\\/publisher\\\/6740\",\"data\":{\"version\":5,\"show\":{\"title\":\"Truth for Health\",\"subtitle\":\"Whistleblower Report\",\"summary\":\"The Whistleblower Report\\u2122 will shine a light of truth, from a variety of perspectives and voices. Hosted by a core team of content experts in different fields, with invited guest whistleblowers. The Whistleblower Report\\u2122 focuses on the following topical areas: Military, Pediatric, Legal, Faith, Medical, and so much more.\",\"poster\":\"https:\\\/\\\/www.truthforhealth.org\\\/wp-content\\\/cache\\\/podlove\\\/72\\\/c609b2aca5f82ba2e4c57a6d6ce2f2\\\/truth-for-health_500x.jpg\",\"link\":\"https:\\\/\\\/www.truthforhealth.org\\\/whistleblower-reports\"},\"title\":\"MHRA Jeopardizes Lives with Safety Oversight Failures in New \\u201cPoint of Care\\u201d Manufacturing Model\",\"subtitle\":\"Inside Big Pharma\",\"summary\":\"Britain\\u2019s Medical Health Products Regulatory Agency (MHRA), now headed by Laura Squire, PhD, a career bureaucrat with no experience in manufacture and regulation of medicines, is moving to a new \\u201cpoint-of-care\\u201d manufacturing model. This is a very serious and major departure from long-standing safety oversight and regulation of compliance with the required Good Manufacturing Practices (GMP) that have been the requirements for pharmaceutical companies throughout the modern era of production of medicines since the 1930s.\",\"publicationDate\":\"2023-08-18T19:10:26+00:00\",\"duration\":\"00:50:40.896\",\"poster\":\"https:\\\/\\\/www.truthforhealth.org\\\/wp-content\\\/cache\\\/podlove\\\/65\\\/e24721fb66732f3f11123f16162c99\\\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model_500x.png\",\"link\":\"https:\\\/\\\/www.truthforhealth.org\\\/es\\\/2023\\\/08\\\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\\\/\",\"chapters\":[],\"audio\":[{\"url\":\"https:\\\/\\\/www.truthforhealth.org\\\/es\\\/podlove\\\/file\\\/61\\\/s\\\/webplayer\\\/c\\\/website\\\/wbr_08-18-23.mp3\",\"size\":\"33674277\",\"title\":\"MP3 Audio (mp3)\",\"mimeType\":\"audio\\\/mpeg\"}],\"files\":[{\"url\":\"https:\\\/\\\/www.truthforhealth.org\\\/es\\\/podlove\\\/file\\\/61\\\/s\\\/webplayer\\\/wbr_08-18-23.mp3\",\"size\":\"33674277\",\"title\":\"MP3 Audio\",\"mimeType\":\"audio\\\/mpeg\"}]}}, {\"url\":\"https:\\\/\\\/www.truthforhealth.org\\\/es\\\/wp-json\\\/podlove-web-player\\\/shortcode\\\/config\\\/default\\\/theme\\\/default\",\"data\":{\"activeTab\":\"chapters\",\"subscribe-button\":null,\"share\":{\"channels\":[\"facebook\",\"twitter\",\"whats-app\",\"linkedin\",\"pinterest\",\"xing\",\"mail\",\"link\"],\"outlet\":\"https:\\\/\\\/www.truthforhealth.org\\\/wp-content\\\/plugins\\\/podlove-web-player\\\/web-player\\\/share.html\",\"sharePlaytime\":true},\"related-episodes\":{\"source\":\"disabled\",\"value\":null},\"version\":5,\"theme\":{\"tokens\":{\"brand\":\"#E64415\",\"brandDark\":\"#235973\",\"brandDarkest\":\"#1A3A4A\",\"brandLightest\":\"#E9F1F5\",\"shadeDark\":\"#807E7C\",\"shadeBase\":\"#807E7C\",\"contrast\":\"#000\",\"alt\":\"#fff\"},\"fonts\":{\"ci\":{\"name\":\"ci\",\"family\":[\"-apple-system\",\"BlinkMacSystemFont\",\"Segoe UI\",\"Roboto\",\"Helvetica\",\"Arial\",\"sans-serif\",\"Apple Color Emoji\",\"Segoe UI Emoji\\\", \\\"Segoe UI Symbol\"],\"src\":[],\"weight\":800},\"regular\":{\"name\":\"regular\",\"family\":[\"-apple-system\",\"BlinkMacSystemFont\",\"Segoe UI\",\"Roboto\",\"Helvetica\",\"Arial\",\"sans-serif\",\"Apple Color Emoji\",\"Segoe UI Emoji\\\", \\\"Segoe UI Symbol\"],\"src\":[],\"weight\":300},\"bold\":{\"name\":\"bold\",\"family\":[\"-apple-system\",\"BlinkMacSystemFont\",\"Segoe UI\",\"Roboto\",\"Helvetica\",\"Arial\",\"sans-serif\",\"Apple Color Emoji\",\"Segoe UI Emoji\\\", \\\"Segoe UI Symbol\"],\"src\":[],\"weight\":700}}},\"base\":\"https:\\\/\\\/www.truthforhealth.org\\\/wp-content\\\/plugins\\\/podlove-web-player\\\/web-player\\\/\"}}]);\n                podlovePlayer(player, \"https:\/\/www.truthforhealth.org\/es\/wp-json\/podlove-web-player\/shortcode\/publisher\/6740\", \"https:\/\/www.truthforhealth.org\/es\/wp-json\/podlove-web-player\/shortcode\/config\/default\/theme\/default\").then(function() {\n                  player && player.classList.remove(\"podlove-web-player-loading\");\n                });\n              });\n            <\/script>\n            <style>\n              .podlove-web-player.podlove-web-player-loading {\n                opacity: 0;\n              }\n            <\/style>\n        \n\n\n\n<p class=\"wp-block-paragraph\">Britain\u2019s Medical Health Products Regulatory Agency (MHRA), now headed by Laura Squire, PhD, a career bureaucrat with <em>no experience <\/em>in manufacture and regulation of medicines, is moving to a new \u201cpoint-of-care\u201d manufacturing model. This is a very serious and major departure from long-standing safety oversight and regulation of compliance with the required Good Manufacturing Practices (GMP) that have been the requirements for pharmaceutical companies throughout the modern era of production of medicines since the 1930s. To understand how serious this change and the jeopardy to the public, read more here: &nbsp;<a href=\"https:\/\/open.substack.com\/pub\/hedleyrees\/p\/mhras-point-of-care-manufacture\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/open.substack.com\/pub\/hedleyrees\/p\/mhras-point-of-care-manufacture<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>MHRA states in a recent letter: <\/strong><em>\u201cThe proposed mechanism for oversight is a PoC Master File that names the \u2018Control site\u2019 and all satellite sites that carry out manufacture of PoC products. The Control site must hold an appropriate license (e.g. MIA or (MIA)IMP) and would be responsible for all satellite sites.\u201d<\/em> (Note: MHRA is still carrying out \u2018distant\u2019 or virtual inspections using <a href=\"https:\/\/www.microsoft.com\/en-gb\/hololens#layout-container-uid22242\" target=\"_blank\" rel=\"noreferrer noopener\">Microsoft HoloLens 2<\/a> (used all the way through the plandemic). Virtual distant inspections are not suitable for insuring safety and quality in manufacturing to meet the criteria for licensing.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>So, where are the Control Sites? Who will be in charge? How many satellite sites will there be? Presumably they are hospital pharmacies, if it is Point of Care manufacture? What skills and experience will the pharmacists and staff in these satellites have? Who will inspect the hospital pharmacies\u2019 quality management systems?\u201d<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Hedley Rees, pharmaceutical manufacturing consultant, had submitted a FOI\/Open Letter questioning the changes to MHRA Regulations in January 2022 that would allow hospital pharmacies to \u2018Manufacture\u2019 COVID injections, even though they did not have the expertise or equipment to safely and properly \u201cfinish\u201d the production of these injections. Here is the text of his letter:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201c<em>Subject: FOI Request\u2014substantial change in <a href=\"https:\/\/www.pharmaceuticalpress.com\/product\/rules-and-guidance-for-pharmaceutical-manufacturers-and-distributions-the-mhra-orange-guide-2022\/\" target=\"_blank\" rel=\"noreferrer noopener\">2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors<\/a>: PART IV \u201cGuidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products (ATMPs)\u201d<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>I would like to request information relating to the Subject above, under the FOIA (Please refer to the Appendix for background and supporting information):<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>1.Is this change fully aligned with EUs REGULATION (EC) NO 1394\/2007on ATMPs? (if not, UK can\u2019t sell into EU, as it will be out of alignment with its regulations)<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>2.Since these new regulations, allowing thawing, manipulation of multi-dose products, etc, were only introduced this year, how was it possible to approve frozen mRNA vaccines under The Orange Guide2017 edition?<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>3.Has a formal consultation involving UK organizations impacted by the change been undertaken? (MHRA routinely holds consultations, for example \u201cConsultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices\u2019 safety\u201d).<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>4.Why does the change apply to ATMPs only?5.Given that the change has been implemented, additional urgent questions arise:<\/em><\/p>\n\n\n\n<ol class=\"wp-block-list\" type=\"a\">\n<li><em>Under the terms of a Marketing Authorization (MA), the Marketing Authorization Holder (MAH) has full responsibility for the safety of its product(s), and the associated responsibility for pharmacovigilance. How will a MAH fulfil its responsibilities to the license, for an ATMP, when a third-party organization can make unlicensed changes to the product?<\/em><\/li>\n\n\n\n<li><em>The same question applies to sponsors of clinical trials for ATMPs.<\/em><\/li>\n\n\n\n<li><em>What actions have been taken to ensure that hospital pharmacies (MHRAs example), provide equivalent controls over product quality compared with Good Manufacturing Practice (GMP)? For example, provision of staff training, standard operating procedures, equipment validation, and investigation of quality deviations?<\/em><\/li>\n\n\n\n<li><em>What provisions are there for hospital pharmacies to comply with Good Distribution Practice (GDP) also?<\/em><\/li>\n\n\n\n<li><em>What is the alternative Quality System for hospital pharmacies?<\/em><\/li>\n\n\n\n<li><em>Aside from hospital pharmacies, what other organizations will be allowed to reconstitute ATMPs according to the change? This request is of the utmost urgency, given the current intense activity in the development of mRNA and viral vector-based products (ATMPs), following the SARS-CoV-2 outbreak and the subsequent ongoing programs of inoculation.<\/em><\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Yours sincerely, Hedley Rees, <a href=\"mailto:h.rees@pharmaflowltd.com\">h.rees@pharmaflowltd.com<\/a>\u201d<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Full text and appendix here: <a href=\"https:\/\/www.dropbox.com\/s\/zapi2juxydohw6i\/14112022_Open_Letter_MHRA.pdf?dl=0\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.dropbox.com\/s\/zapi2juxydohw6i\/14112022_Open_Letter_MHRA.pdf?dl=0<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em><strong>It\u2019s difficult to overstate the seriousness of breach of long-standing manufacturing quality and safety regulations in the MHRA\u2019s change to Point-of-Care manufacturing, and the degree to which public safety is jeopardized. <\/strong><\/em><strong>UK\u2019s MHRA seems to be the \u201ctip of the spear\u201d leading other regulatory agencies (FDA, EMA, etc.) to make similar changes, this is a dangerous change for all Americans to resist. We must communicate with elected officials that this deviation from Good Manufacturing Practices is an unacceptable risk to people\u2019s lives.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For more information go to Truth for Health Foundation website AND Access our archive of all our shows at <a href=\"http:\/\/www.WhisteblowerReports.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.WhisteblowerReports.org<\/a>. Check out medical and legal resources for help at <a href=\"http:\/\/www.TruthForHealth.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.TruthForHealth.org<\/a> to download our <em>Vaccine Injury Treatment Guide. <\/em>If you have been injured by any vaccine, go to <a href=\"http:\/\/www.vaccinedamage.org\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.vaccinedamage.org<\/a> to file a <em>Citizens Vaccine Injury Report.<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Your generosity keeps us in the fight for Truth.<\/strong> We still have major battles to defend our freedom on all fronts, especially for our military who are needing legal defense support. Your contributions will greatly help us support more legal defense grants to help defend our human and civil rights secured by law under the US Constitution. <em><strong><a href=\"https:\/\/secure.anedot.com\/truth-for-health-foundation\/donate\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/secure.anedot.com\/truth-for-health-foundation\/donate<\/a><\/strong><\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Join our Crusade of the Voiceless\u2026WE ARE SILENT NO MORE<\/strong><strong>! <\/strong>Sign up for our weekly email newsletter and join our crusade for preserving freedom on all fronts.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">HOST BACKGROUND AND WEBSITE RESOURCES:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Hedley Rees, <\/strong>based in the United Kingdom. Mr. Rees has been providing consultancy on the development, manufacture and distribution of drugs that are fully compliant with the GMP requirements of 21 CFR Title 21, since 2005 through his company, <a href=\"https:\/\/www.pharmaflowltd.com\/company\/\" target=\"_blank\" rel=\"noreferrer noopener\">PharmaFlow<\/a>. Prior to that, he spent 16 years in senior roles in Big Pharma (Bayer) and 10 years in biotech (British Biotech, Vernalis and OSI Pharmaceuticals (now Astellas). Mr. Rees also authored <a href=\"https:\/\/www.wiley.com\/en-us\/Supply+Chain+Management+in+the+Drug+Industry%3A+Delivering+Patient+Value+for+Pharmaceuticals+and+Biologics-p-9780470922842\" target=\"_blank\" rel=\"noreferrer noopener\"><em>Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics<\/em><\/a> for Wiley, NJ in 2011. His expertise is in the area of anything to do with manufacture through the three phases of clinical trials (and preclinical if required) and ongoing distribution of the commercial supply. Where regulations have been breached, he has a duty to bring this to the attention of regulators, as has been happening with the frozen vials of COVID shots that were shipped only part way finished.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Hedley joins Truth for Health Foundation Team: <a href=\"https:\/\/open.substack.com\/pub\/hedleyrees\/p\/hedley-joins-truth-for-health-foundation?r=xoehy&amp;utm_campaign=post&amp;utm_medium=web\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/open.substack.com\/pub\/hedleyrees\/p\/hedley-joins-truth-for-health-foundation?r=xoehy&amp;utm_campaign=post&amp;utm_medium=web<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Follow Hedley Rees on his Substack column, <a href=\"https:\/\/hedleyrees.substack.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">INSIDE PHARMA<\/a>, where he shares all he can to expose the lies and deceptions that are costing lives and jeopardizing public safety. Watch one of his many interviews here:&nbsp; <a href=\"https:\/\/rumble.com\/v14gou4-drug-development-expert-sounds-alarm-over-rushed-to-market-covid-19-vaccine.html\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/rumble.com\/v14gou4-drug-development-expert-sounds-alarm-over-rushed-to-market-covid-19-vaccine.html<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"> Read more on Facts about SARS-CoV-2 Injections (aka DNA vaccines) and advanced therapy medicinal products (ATMPs)<em>: <\/em><a href=\"https:\/\/open.substack.com\/pub\/hedleyrees\/p\/facts-about-sars-cov-2-injections?r=xoehy&amp;utm_campaign=post&amp;utm_medium=web\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/open.substack.com\/pub\/hedleyrees\/p\/facts-about-sars-cov-2-injections?r=xoehy&amp;utm_campaign=post&amp;utm_medium=web<\/a> Watch Recent interview discussing the violations of manufacturing processes and regulations that are supposed to keep us safe: <a href=\"https:\/\/rumble.com\/v1qe9nk-freeman-interviews-hedley.html\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/rumble.com\/v1qe9nk-freeman-interviews-hedley.html<\/a><\/p>\n","protected":false},"author":3,"featured_media":6741,"comment_status":"closed","ping_status":"open","template":"","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"class_list":["post-6740","podcast","type-podcast","status-publish","has-post-thumbnail","hentry","shows-whistleblower-report","fadeIn","image-hover-transition-effect","latest_post","post"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MHRA Jeopardizes Lives with Safety Oversight Failures in New \u201cPoint of Care\u201d Manufacturing Model - Truth for Health Foundation<\/title>\n<meta name=\"description\" content=\"Britain\u2019s Medical Health Products Regulatory Agency (MHRA), now headed by Laura Squire, PhD, a career bureaucrat with no experience in manufacture and regulation of medicines, is moving to a new \u201cpoint-of-care\u201d manufacturing model. This is a very serious and major departure from long-standing safety oversight and regulation of compliance with the required Good Manufacturing Practices (GMP) that have been the requirements for pharmaceutical companies throughout the modern era of production of medicines since the 1930s.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.truthforhealth.org\/es\/2023\/08\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MHRA Jeopardizes Lives with Safety Oversight Failures in New \u201cPoint of Care\u201d Manufacturing Model - Truth for Health Foundation\" \/>\n<meta property=\"og:description\" content=\"Britain\u2019s Medical Health Products Regulatory Agency (MHRA), now headed by Laura Squire, PhD, a career bureaucrat with no experience in manufacture and regulation of medicines, is moving to a new \u201cpoint-of-care\u201d manufacturing model. This is a very serious and major departure from long-standing safety oversight and regulation of compliance with the required Good Manufacturing Practices (GMP) that have been the requirements for pharmaceutical companies throughout the modern era of production of medicines since the 1930s.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.truthforhealth.org\/es\/2023\/08\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\/\" \/>\n<meta property=\"og:site_name\" content=\"Truth for Health Foundation\" \/>\n<meta property=\"article:modified_time\" content=\"2023-08-21T14:08:39+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.truthforhealth.org\/wp-content\/uploads\/2023\/08\/wbr_08-18-23.png\" \/>\n\t<meta property=\"og:image:width\" content=\"926\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.truthforhealth.org\\\/2023\\\/08\\\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\\\/\",\"url\":\"https:\\\/\\\/www.truthforhealth.org\\\/2023\\\/08\\\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\\\/\",\"name\":\"MHRA Jeopardizes Lives with Safety Oversight Failures in New \u201cPoint of Care\u201d Manufacturing Model - Truth for Health Foundation\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.truthforhealth.org\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.truthforhealth.org\\\/2023\\\/08\\\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.truthforhealth.org\\\/2023\\\/08\\\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.truthforhealth.org\\\/wp-content\\\/uploads\\\/2023\\\/08\\\/wbr_08-18-23.png\",\"datePublished\":\"2023-08-18T19:10:26+00:00\",\"dateModified\":\"2023-08-21T14:08:39+00:00\",\"description\":\"Britain\u2019s Medical Health Products Regulatory Agency (MHRA), now headed by Laura Squire, PhD, a career bureaucrat with no experience in manufacture and regulation of medicines, is moving to a new \u201cpoint-of-care\u201d manufacturing model. This is a very serious and major departure from long-standing safety oversight and regulation of compliance with the required Good Manufacturing Practices (GMP) that have been the requirements for pharmaceutical companies throughout the modern era of production of medicines since the 1930s.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.truthforhealth.org\\\/2023\\\/08\\\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\\\/#breadcrumb\"},\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.truthforhealth.org\\\/2023\\\/08\\\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/www.truthforhealth.org\\\/2023\\\/08\\\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\\\/#primaryimage\",\"url\":\"https:\\\/\\\/www.truthforhealth.org\\\/wp-content\\\/uploads\\\/2023\\\/08\\\/wbr_08-18-23.png\",\"contentUrl\":\"https:\\\/\\\/www.truthforhealth.org\\\/wp-content\\\/uploads\\\/2023\\\/08\\\/wbr_08-18-23.png\",\"width\":926,\"height\":600},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.truthforhealth.org\\\/2023\\\/08\\\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/www.truthforhealth.org\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Episodes\",\"item\":\"https:\\\/\\\/www.truthforhealth.org\\\/whistleblower-reports\\\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"MHRA Jeopardizes Lives with Safety Oversight Failures in New \u201cPoint of Care\u201d Manufacturing Model\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.truthforhealth.org\\\/#website\",\"url\":\"https:\\\/\\\/www.truthforhealth.org\\\/\",\"name\":\"https:\\\/\\\/www.trugthforhealth.org\",\"description\":\"A 501(c)(3) public charity incorporated in Arizona, USA\",\"publisher\":{\"@id\":\"https:\\\/\\\/www.truthforhealth.org\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.truthforhealth.org\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/www.truthforhealth.org\\\/#organization\",\"name\":\"Truth for Health Foundation\",\"url\":\"https:\\\/\\\/www.truthforhealth.org\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/www.truthforhealth.org\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/www.truthforhealth.org\\\/wp-content\\\/uploads\\\/2025\\\/02\\\/Truth_for_Health_Logo_trademarked.png\",\"contentUrl\":\"https:\\\/\\\/www.truthforhealth.org\\\/wp-content\\\/uploads\\\/2025\\\/02\\\/Truth_for_Health_Logo_trademarked.png\",\"width\":1225,\"height\":310,\"caption\":\"Truth for Health Foundation\"},\"image\":{\"@id\":\"https:\\\/\\\/www.truthforhealth.org\\\/#\\\/schema\\\/logo\\\/image\\\/\"}}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"MHRA Jeopardizes Lives with Safety Oversight Failures in New \u201cPoint of Care\u201d Manufacturing Model - Truth for Health Foundation","description":"Britain\u2019s Medical Health Products Regulatory Agency (MHRA), now headed by Laura Squire, PhD, a career bureaucrat with no experience in manufacture and regulation of medicines, is moving to a new \u201cpoint-of-care\u201d manufacturing model. This is a very serious and major departure from long-standing safety oversight and regulation of compliance with the required Good Manufacturing Practices (GMP) that have been the requirements for pharmaceutical companies throughout the modern era of production of medicines since the 1930s.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.truthforhealth.org\/es\/2023\/08\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\/","og_locale":"es_MX","og_type":"article","og_title":"MHRA Jeopardizes Lives with Safety Oversight Failures in New \u201cPoint of Care\u201d Manufacturing Model - Truth for Health Foundation","og_description":"Britain\u2019s Medical Health Products Regulatory Agency (MHRA), now headed by Laura Squire, PhD, a career bureaucrat with no experience in manufacture and regulation of medicines, is moving to a new \u201cpoint-of-care\u201d manufacturing model. This is a very serious and major departure from long-standing safety oversight and regulation of compliance with the required Good Manufacturing Practices (GMP) that have been the requirements for pharmaceutical companies throughout the modern era of production of medicines since the 1930s.","og_url":"https:\/\/www.truthforhealth.org\/es\/2023\/08\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\/","og_site_name":"Truth for Health Foundation","article_modified_time":"2023-08-21T14:08:39+00:00","og_image":[{"width":926,"height":600,"url":"https:\/\/www.truthforhealth.org\/wp-content\/uploads\/2023\/08\/wbr_08-18-23.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Tiempo de lectura":"5 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.truthforhealth.org\/2023\/08\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\/","url":"https:\/\/www.truthforhealth.org\/2023\/08\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\/","name":"MHRA Jeopardizes Lives with Safety Oversight Failures in New \u201cPoint of Care\u201d Manufacturing Model - Truth for Health Foundation","isPartOf":{"@id":"https:\/\/www.truthforhealth.org\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.truthforhealth.org\/2023\/08\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\/#primaryimage"},"image":{"@id":"https:\/\/www.truthforhealth.org\/2023\/08\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\/#primaryimage"},"thumbnailUrl":"https:\/\/www.truthforhealth.org\/wp-content\/uploads\/2023\/08\/wbr_08-18-23.png","datePublished":"2023-08-18T19:10:26+00:00","dateModified":"2023-08-21T14:08:39+00:00","description":"Britain\u2019s Medical Health Products Regulatory Agency (MHRA), now headed by Laura Squire, PhD, a career bureaucrat with no experience in manufacture and regulation of medicines, is moving to a new \u201cpoint-of-care\u201d manufacturing model. This is a very serious and major departure from long-standing safety oversight and regulation of compliance with the required Good Manufacturing Practices (GMP) that have been the requirements for pharmaceutical companies throughout the modern era of production of medicines since the 1930s.","breadcrumb":{"@id":"https:\/\/www.truthforhealth.org\/2023\/08\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\/#breadcrumb"},"inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.truthforhealth.org\/2023\/08\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.truthforhealth.org\/2023\/08\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\/#primaryimage","url":"https:\/\/www.truthforhealth.org\/wp-content\/uploads\/2023\/08\/wbr_08-18-23.png","contentUrl":"https:\/\/www.truthforhealth.org\/wp-content\/uploads\/2023\/08\/wbr_08-18-23.png","width":926,"height":600},{"@type":"BreadcrumbList","@id":"https:\/\/www.truthforhealth.org\/2023\/08\/mhra-jeopardizes-lives-with-safety-oversight-failures-in-new-point-of-care-manufacturing-model\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.truthforhealth.org\/"},{"@type":"ListItem","position":2,"name":"Episodes","item":"https:\/\/www.truthforhealth.org\/whistleblower-reports\/"},{"@type":"ListItem","position":3,"name":"MHRA Jeopardizes Lives with Safety Oversight Failures in New \u201cPoint of Care\u201d Manufacturing Model"}]},{"@type":"WebSite","@id":"https:\/\/www.truthforhealth.org\/#website","url":"https:\/\/www.truthforhealth.org\/","name":"https:\/\/www.trugthforhealth.org","description":"A 501(c)(3) public charity incorporated in Arizona, USA","publisher":{"@id":"https:\/\/www.truthforhealth.org\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.truthforhealth.org\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Organization","@id":"https:\/\/www.truthforhealth.org\/#organization","name":"Truth for Health Foundation","url":"https:\/\/www.truthforhealth.org\/","logo":{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/www.truthforhealth.org\/#\/schema\/logo\/image\/","url":"https:\/\/www.truthforhealth.org\/wp-content\/uploads\/2025\/02\/Truth_for_Health_Logo_trademarked.png","contentUrl":"https:\/\/www.truthforhealth.org\/wp-content\/uploads\/2025\/02\/Truth_for_Health_Logo_trademarked.png","width":1225,"height":310,"caption":"Truth for Health Foundation"},"image":{"@id":"https:\/\/www.truthforhealth.org\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/www.truthforhealth.org\/es\/wp-json\/wp\/v2\/episodes\/6740","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.truthforhealth.org\/es\/wp-json\/wp\/v2\/episodes"}],"about":[{"href":"https:\/\/www.truthforhealth.org\/es\/wp-json\/wp\/v2\/types\/podcast"}],"author":[{"embeddable":true,"href":"https:\/\/www.truthforhealth.org\/es\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.truthforhealth.org\/es\/wp-json\/wp\/v2\/comments?post=6740"}],"version-history":[{"count":2,"href":"https:\/\/www.truthforhealth.org\/es\/wp-json\/wp\/v2\/episodes\/6740\/revisions"}],"predecessor-version":[{"id":6746,"href":"https:\/\/www.truthforhealth.org\/es\/wp-json\/wp\/v2\/episodes\/6740\/revisions\/6746"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.truthforhealth.org\/es\/wp-json\/wp\/v2\/media\/6741"}],"wp:attachment":[{"href":"https:\/\/www.truthforhealth.org\/es\/wp-json\/wp\/v2\/media?parent=6740"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.truthforhealth.org\/es\/wp-json\/wp\/v2\/tags?post=6740"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}