{"id":7395,"date":"2026-06-16T08:30:04","date_gmt":"2026-06-16T06:30:04","guid":{"rendered":"https:\/\/www.logisticcompany.it\/?p=7395"},"modified":"2026-05-29T10:50:28","modified_gmt":"2026-05-29T08:50:28","slug":"storage-of-active-pharmaceutical-ingredients-gmp-safety-and-compliance","status":"publish","type":"post","link":"https:\/\/www.logisticcompany.it\/en\/storage-of-active-pharmaceutical-ingredients-gmp-safety-and-compliance\/","title":{"rendered":"Storage of Active Pharmaceutical Ingredients: GMP Safety and Compliance"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-margin-top:-50px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1216.8px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 fusion-title-text fusion-title-size-one\" style=\"--awb-margin-bottom:0px;--awb-margin-top-small:0px;--awb-margin-bottom-small:20px;--awb-font-size:55px;\"><div class=\"title-sep-container title-sep-container-left fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><span class=\"awb-title-spacer fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><\/span><h1 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"font-family:&quot;Anek Devanagari&quot;;font-style:normal;font-weight:600;margin:0;text-transform:none;font-size:1em;--fontSize:55;line-height:1.2;\">Storage of Active Pharmaceutical Ingredients: GMP Safety and Compliance<\/h1><span class=\"awb-title-spacer\"><\/span><div class=\"title-sep-container title-sep-container-right\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><\/div><div class=\"fusion-title title fusion-title-2 fusion-title-text fusion-title-size-three\" style=\"--awb-margin-top-small:0px;--awb-margin-bottom-small:20px;\"><div class=\"title-sep-container title-sep-container-left fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><span class=\"awb-title-spacer fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><\/span><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;text-transform:none;--fontSize:25;line-height:var(--awb-typography1-line-height);\">The storage of active pharmaceutical ingredients takes place in AIFA authorized warehouses, according to GMP standards that assure safety, control and traceability along the supply chain.<\/h3><span class=\"awb-title-spacer\"><\/span><div class=\"title-sep-container title-sep-container-right\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p><span style=\"font-weight: 400;\">In the <\/span><a href=\"https:\/\/www.assolombarda.it\/le-imprese\/filiere\/filiera-life-sciences\/informazioni\/scopri-la-filiera-life-sciences\"><b>Life Science sector<\/b><\/a><span style=\"font-weight: 400;\">, <\/span><b>logistics<\/b><span style=\"font-weight: 400;\"> is not an ancillary activity, but an essential element in ensuring the quality and safety of medicines along the supply chain.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In particular, the <\/span><b>storage of active pharmaceutical ingredients<\/b><span style=\"font-weight: 400;\"> (APIs) is a delicate phase, in which safety, control and regulatory compliance are essential to ensure the quality of the final product.<\/span><\/p>\n<p>\u00a0<\/p>\n<p><span style=\"font-weight: 400;\">In fact, variations in temperature, humidity or environmental exposure can compromise the stability of an <\/span><b>active ingredient<\/b><span style=\"font-weight: 400;\">. For this reason, <\/span><b>API management<\/b><span style=\"font-weight: 400;\"> requires specialized infrastructure and processes controlled according to <\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/compliance-research-development\/good-manufacturing-practice\"><b>Good Manufacturing Practice<\/b><\/a><span style=\"font-weight: 400;\"> (GMP)<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><b>At Logistic Company, storage<\/b><span style=\"font-weight: 400;\"> is therefore treated as a direct extension of the production process: each <\/span><b>pharmaceutical API<\/b><span style=\"font-weight: 400;\"> is stored in qualified environments, constantly monitored and managed according to international standards, in order to preserve its <\/span><b>chemi-physical integrity and therapeutic efficacy.<\/b><\/p>\n<\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:20px;margin-bottom:20px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:10px;\"><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-3 fusion-title-text fusion-title-size-two\" style=\"--awb-margin-bottom:20px;--awb-margin-top-small:0px;--awb-margin-bottom-small:20px;\"><div class=\"title-sep-container title-sep-container-left fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><span class=\"awb-title-spacer fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><\/span><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;text-transform:none;--fontSize:35;line-height:var(--awb-typography1-line-height);\">What are active pharmaceutical ingredients?<\/h2><span class=\"awb-title-spacer\"><\/span><div class=\"title-sep-container title-sep-container-right\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-2\"><p><b>Active pharmaceutical ingredients<\/b><span style=\"font-weight: 400;\">, or <\/span><b>APIs <\/b><span style=\"font-weight: 400;\">(Active Pharmaceutical Ingredients), are the pharmacologically active substances responsible for the t<\/span><b>herapeutic effect of a medicine.<\/b><span style=\"font-weight: 400;\"> Their quality directly influences the efficacy and safety of the medicine.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For this reason, <\/span><b>APIs<\/b><span style=\"font-weight: 400;\"> must be managed very carefully throughout the supply chain. They are sensitive to factors such as <\/span><b>light<\/b><span style=\"font-weight: 400;\">, <\/span><b>heat<\/b><span style=\"font-weight: 400;\"> and <\/span><b>humidity<\/b><span style=\"font-weight: 400;\">, and their storage conditions must be fully traceable, from <\/span><b>receipt<\/b><span style=\"font-weight: 400;\"> to <\/span><b>storage<\/b><span style=\"font-weight: 400;\"> to shipment and , then, to the production facility of the finished products.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:20px;margin-bottom:20px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:10px;\"><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-4 fusion-title-text fusion-title-size-two\" style=\"--awb-margin-bottom:20px;--awb-margin-top-small:0px;--awb-margin-bottom-small:20px;\"><div class=\"title-sep-container title-sep-container-left fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><span class=\"awb-title-spacer fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><\/span><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;text-transform:none;--fontSize:35;line-height:var(--awb-typography1-line-height);\">The role of logistics in the management of active ingredients<\/h2><span class=\"awb-title-spacer\"><\/span><div class=\"title-sep-container title-sep-container-right\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-3\"><p><span style=\"font-weight: 400;\">Pharmaceutical <\/span><b>logistics<\/b><span style=\"font-weight: 400;\"> is not limited to transportation, but includes the complete management of raw materials as well.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Each <\/span><b>phase<\/b><span style=\"font-weight: 400;\"> is precisely planned and controlled:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Reception: <\/b><span style=\"font-weight: 400;\">verification of the quality and quantity of the active ingredients upon arrival.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Storage: <\/b><span style=\"font-weight: 400;\">maintenance under controlled conditions (e.g.: refrigeration for thermolabile drugs)<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Internal transport:<\/b><span style=\"font-weight: 400;\"> safe handling within warehouses or production sites.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Distribution: <\/b><span style=\"font-weight: 400;\">delivery to pharmaceutical manufacturing facilities or distributors.<\/span><\/li>\n<\/ol>\n<p><span style=\"font-weight: 400;\">Elements such as <\/span><b>chemical stability<\/b><span style=\"font-weight: 400;\">, <\/span><b>shelf life<\/b><span style=\"font-weight: 400;\"> and <\/span><b>sensitivity of the active pharmaceutical<\/b> <b>ingredient<\/b><span style=\"font-weight: 400;\"> guide all operational decisions, from reception to <\/span><b>storage<\/b><span style=\"font-weight: 400;\"> to distribution, reducing the risks of alteration or contamination.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-5 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:20px;margin-bottom:20px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:10px;\"><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-6 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-5 fusion-title-text fusion-title-size-two\" style=\"--awb-margin-bottom:20px;--awb-margin-top-small:0px;--awb-margin-bottom-small:20px;\"><div class=\"title-sep-container title-sep-container-left fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><span class=\"awb-title-spacer fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><\/span><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;text-transform:none;--fontSize:35;line-height:var(--awb-typography1-line-height);\">Infrastructure and GMP requirements for storage<\/h2><span class=\"awb-title-spacer\"><\/span><div class=\"title-sep-container title-sep-container-right\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-4\"><p><span style=\"font-weight: 400;\">As far as the storage of active pharmaceutical ingredients is concerned, this phase requires infrastructures designed according to strict criteria. In fact, the suitable environment must assured:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Areas separated <\/b><span style=\"font-weight: 400;\">by type and condition of the material<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>Controlled layout<\/b><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><b>HVAC Systems <\/b><span style=\"font-weight: 400;\">for Environmental Control<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Continuous monitoring of <\/span><b>temperature <\/b><span style=\"font-weight: 400;\">and<\/span><b> humidity<\/b><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">The <\/span><b>traceability of raw materials<\/b><span style=\"font-weight: 400;\"> is also a fundamental requirement. Each component of each batch (e.g. each pallet) is recorded with information on supplier, production date, entry date, expiry date, status and position within the warehouse.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Moreover, <\/span><b>FIFO<\/b><span style=\"font-weight: 400;\"> and <\/span><b>FEFO<\/b><span style=\"font-weight: 400;\"> logics ensure proper stock turnover, while <\/span><b>SOPs <\/b><span style=\"font-weight: 400;\">(Standard Operating Procedures) govern every operational phase, from receipt to shipment.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">All these procedures are supervised by a <\/span><b>Quality system<\/b><span style=\"font-weight: 400;\"> based on <\/span><b>GMP<\/b><span style=\"font-weight: 400;\">, with <\/span><b>periodic audits<\/b><span style=\"font-weight: 400;\"> by health authorities (e.g., AIFA for Italy, FDA for the USA) to ensure the compliance.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-7 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:20px;margin-bottom:20px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:10px;\"><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-8 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-6 fusion-title-text fusion-title-size-two\" style=\"--awb-margin-bottom:20px;--awb-margin-top-small:0px;--awb-margin-bottom-small:20px;\"><div class=\"title-sep-container title-sep-container-left fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><span class=\"awb-title-spacer fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><\/span><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;text-transform:none;--fontSize:35;line-height:var(--awb-typography1-line-height);\">Quarantine management and batch control<\/h2><span class=\"awb-title-spacer\"><\/span><div class=\"title-sep-container title-sep-container-right\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-5\"><p><span style=\"font-weight: 400;\">One of the critical aspects in <\/span><b>the storage of active pharmaceutical ingredients<\/b><span style=\"font-weight: 400;\"> is the <\/span><b>management of the quarantine<\/b><span style=\"font-weight: 400;\"> of materials.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Each <\/span><b>batch of API<\/b><span style=\"font-weight: 400;\"> is immediately identified and segregated in dedicated areas, where it remains in quarantine until release, authorization for use by the responsible Qualified Person. No material may be used in manufacture prior to <\/span><b>formal approval.<\/b><\/p>\n<p><span style=\"font-weight: 400;\">This approach guarantees maximum <\/span><b>transparency<\/b><span style=\"font-weight: 400;\"> and full documentary control, essential elements during <\/span><b>GMP inspections <\/b><span style=\"font-weight: 400;\">conducted by regulatory bodies, such as <\/span><a href=\"https:\/\/www.aifa.gov.it\/\"><b>AIFA<\/b><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-9 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-padding-left:20px;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-7 fusion-title-text fusion-title-size-three\" style=\"--awb-margin-bottom:20px;--awb-margin-top-small:0px;--awb-margin-bottom-small:20px;\"><div class=\"title-sep-container title-sep-container-left fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><span class=\"awb-title-spacer fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><\/span><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;text-transform:none;--fontSize:25;line-height:var(--awb-typography1-line-height);\">From quarantine to change of state in API storage<\/h3><span class=\"awb-title-spacer\"><\/span><div class=\"title-sep-container title-sep-container-right\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-6\"><p><span style=\"font-weight: 400;\">In the <\/span><b>storage of active pharmaceutical ingredients<\/b><span style=\"font-weight: 400;\">, the post-quarantine phase is represented by the change of status.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Once the required checks have been completed and the qualified person has been released, the <\/span><b>API<\/b><span style=\"font-weight: 400;\"> can be transferred <\/span><b>from the \u201cquarantine\u201d state to the \u201capproved\u201d state, which is available for use.<\/b><\/p>\n<p><span style=\"font-weight: 400;\">Any change in status is authorized exclusively through <\/span><b>validated management systems<\/b><span style=\"font-weight: 400;\">, which record every single operation in compliance with <\/span><b>GMP procedures.<\/b><\/p>\n<p><span style=\"font-weight: 400;\">This ensures continuity and full traceability within the<\/span><b> storage process<\/b><span style=\"font-weight: 400;\">, which is one of the most critical elements during audits and regulatory inspections.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-10 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:20px;margin-bottom:20px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;--awb-sep-color:var(--awb-color5);border-color:var(--awb-color5);border-top-width:10px;\"><\/div><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-11 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-8 fusion-title-text fusion-title-size-two\" style=\"--awb-margin-bottom:20px;--awb-margin-top-small:0px;--awb-margin-bottom-small:20px;\"><div class=\"title-sep-container title-sep-container-left fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><span class=\"awb-title-spacer fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><\/span><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;text-transform:none;--fontSize:35;line-height:var(--awb-typography1-line-height);\">AIFA authorized warehouse: a guarantee in the storage of APIs<\/h2><span class=\"awb-title-spacer\"><\/span><div class=\"title-sep-container title-sep-container-right\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-7\"><p><span style=\"font-weight: 400;\">All activities related to the<\/span><b> storage of active pharmaceutical ingredients<\/b><span style=\"font-weight: 400;\">, including quarantine management and change of status of medicines, can only be carried out within <\/span><b>sites authorized<\/b><span style=\"font-weight: 400;\"> and inspected by the competent authorities, such as, for example, <\/span><b>AIFA<\/b><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Relying on an <\/span><a href=\"https:\/\/www.logisticcompany.it\/en\/authorisations\/\"><b>AIFA authorized warehouse<\/b><\/a><span style=\"font-weight: 400;\">\u00a0therefore means complying not only with structural requirements, but also with a <\/span><b>rigorous Quality system<\/b><span style=\"font-weight: 400;\">, based on operating procedures, quality control and document traceability, fully compliant with the requirements dictated by <\/span><b>Good Manufacturing Practice (GMP).<\/b><\/p>\n<p><span style=\"font-weight: 400;\">It is therefore an integrated model that guarantees product <\/span><b>safety at a fundamental stage throughout the supply chain.<\/b><span style=\"font-weight: 400;\"> For<\/span><b> pharmaceutical companies<\/b><span style=\"font-weight: 400;\">, this is a key element in choosing a logistics partner that specializes in <\/span><b>the storage of active pharmaceutical ingredients.<\/b><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-12 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-padding-left:20px;--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-9 fusion-title-text fusion-title-size-three\" style=\"--awb-margin-bottom:20px;--awb-margin-top-small:0px;--awb-margin-bottom-small:20px;\"><div class=\"title-sep-container title-sep-container-left fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><span class=\"awb-title-spacer fusion-no-large-visibility fusion-no-medium-visibility fusion-no-small-visibility\"><\/span><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;text-transform:none;--fontSize:25;line-height:var(--awb-typography1-line-height);\">Logistic Company: a qualified partner for the storage of APIs<\/h3><span class=\"awb-title-spacer\"><\/span><div class=\"title-sep-container title-sep-container-right\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-8\"><p><span style=\"font-weight: 400;\">In this regulated and highly structured context, the effectiveness of the <\/span><b>storage of active pharmaceutical ingredients<\/b><span style=\"font-weight: 400;\"> depends on the ability to maintain optimal environmental conditions and comply with international guidelines, mainly GMP standards.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Logistic Company\u2019s AIFA authorized warehouses o<\/span><b>perate according to these principles,thanks to a Quality system, advanced technologies and validated procedures that control every phase of the supply chain, from the receipt of the API in storage to its shipment, ensuring full traceability and continuous control of batches for<\/b><span style=\"font-weight: 400;\"> pharmaceutical companies.<\/span><\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-13 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-padding-top:40px;--awb-padding-bottom:40px;--awb-bg-color:var(--awb-color5);--awb-bg-color-hover:var(--awb-color5);--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:19px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-10 fusion-title-center fusion-title-text fusion-title-size-three\" style=\"--awb-text-color:var(--awb-color1);--awb-margin-bottom:20px;--awb-margin-top-small:0px;--awb-margin-bottom-small:20px;\"><div class=\"title-sep-container title-sep-container-left\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><span class=\"awb-title-spacer\"><\/span><h3 class=\"fusion-title-heading title-heading-center fusion-responsive-typography-calculated\" style=\"margin:0;text-transform:none;--fontSize:25;line-height:var(--awb-typography1-line-height);\"><strong>Do you want to ensure maximum compliance and security in API storage?<\/strong><\/h3><span class=\"awb-title-spacer\"><\/span><div class=\"title-sep-container title-sep-container-right\"><div class=\"title-sep sep- sep-solid\" style=\"border-color:var(--awb-color3);\"><\/div><\/div><\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-custom fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_accent_color:var(--awb-color8);--button_accent_hover_color:var(--awb-color5);--button_border_hover_color:var(--awb-color5);--button_border_width-top:2PX;--button_border_width-right:2PX;--button_border_width-bottom:2px;--button_border_width-left:2PX;--button-border-radius-top-left:10px;--button-border-radius-top-right:10px;--button-border-radius-bottom-right:10px;--button-border-radius-bottom-left:10px;--button_gradient_top_color:var(--awb-color1);--button_gradient_bottom_color:var(--awb-color1);--button_gradient_top_color_hover:var(--awb-color1);--button_gradient_bottom_color_hover:var(--awb-color1);--button_font_size:18px;--button_line_height:20px;\" target=\"_self\" href=\"https:\/\/www.logisticcompany.it\/en\/contacts\/\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Contact Logistic Company for a no-obligation consultation<\/span><\/a><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The storage of active pharmaceutical ingredients takes place in AIFA authorized warehouses, complying with the GMP standards that guarantee safety, control and traceability along the supply chain.<\/p>\n","protected":false},"author":9,"featured_media":7393,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[50],"tags":[],"class_list":["post-7395","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Storage of Active Pharmaceutical Ingredients: Safety and GMP Compliance<\/title>\n<meta name=\"description\" content=\"The storage of active pharmaceutical ingredients takes place in AIFA authorized warehouses, complying with the GMP standards that guarantee safety, control and traceability along the supply 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