{"id":1739163,"date":"2025-08-29T16:54:00","date_gmt":"2025-08-29T11:24:00","guid":{"rendered":"https:\/\/pharmint.net\/?post_type=encyclopedia&#038;p=1739163"},"modified":"2025-09-01T18:21:38","modified_gmt":"2025-09-01T12:51:38","slug":"sds-safety-data-sheet","status":"publish","type":"encyclopedia","link":"https:\/\/pharmint.net\/zh\/glossary\/sds-safety-data-sheet\/","title":{"rendered":"SDS (Safety Data Sheet)"},"content":{"rendered":"<h2><strong>What Is an SDS (Safety Data Sheet)?<\/strong><\/h2>\n<p>A&nbsp;<strong>Safety Data Sheet (SDS)<\/strong>&nbsp;is a standardized document that provides critical safety, hazard, and handling information about a chemical substance or mixture. In pharmaceuticals, it applies to&nbsp;<a href=\"https:\/\/pharmint.net\/what-is-active-pharmaceutical-ingredient-api\/\"><strong>APIs<\/strong><\/a><strong>, intermediates,&nbsp;<\/strong><a href=\"https:\/\/pharmint.net\/glossary\/excipient\/\"><strong>excipients<\/strong><\/a><strong>, and solvents<\/strong>&nbsp;used in R&amp;D and manufacturing. SDS documents follow the&nbsp;<strong>GHS (Globally Harmonized System)<\/strong>&nbsp;16-section format.<\/p>\n<h2><strong>Why Is an SDS Important in Pharma?<\/strong><\/h2>\n<p>SDS ensures that workers, manufacturers, and regulators have access to&nbsp;<strong>hazard data, safe-use instructions, and emergency procedures<\/strong>. In pharma supply chains, SDS are vital for:<\/p>\n<ul>\n<li>Protecting personnel in labs and production areas<\/li>\n<li>Supporting&nbsp;<a href=\"https:\/\/pharmint.net\/glossary\/good-manufacturing-practice-gmp\/\">GMP<\/a>&nbsp;and <a href=\"https:\/\/pharmint.net\/zh\/glossary\/reach-compliance\/\" target=\"_self\" title=\"What Is REACH Compliance? REACH&nbsp;stands for&nbsp;Registration, Evaluation, Authorization, and Restriction of Chemicals&mdash;a comprehensive EU chemicals regulation (EC No 1907\/2006) that came into force on 1 June 2007. It governs how chemical substances are manufactured, imported, and used in the EU, and seeks to protect human health and the environment. Who Must Comply with REACH in&hellip;\" class=\"encyclopedia\">REACH compliance<\/a><\/li>\n<li>Facilitating audits and regulatory inspections<\/li>\n<\/ul>\n<h2><strong>What Are the Key Sections of an SDS?<\/strong><\/h2>\n<p>Every SDS must include the following <strong>16 sections<\/strong> under GHS:<\/p>\n<ol>\n<li><strong>Identification<\/strong> &ndash; Provides product name, manufacturer details, and recommended uses.<\/li>\n<li><strong>Hazard(s) Identification<\/strong> &ndash; Lists hazard classifications, warning symbols, and precautionary statements.<\/li>\n<li><strong>Composition\/Information on Ingredients<\/strong> &ndash; Details chemical identity, concentration, and hazardous components.<\/li>\n<li><strong>First-aid Measures<\/strong> &ndash; Outlines immediate medical steps for exposure or ingestion incidents.<\/li>\n<li><strong>Fire-fighting Measures<\/strong> &ndash; Advises on suitable extinguishing media and fire hazards.<\/li>\n<li><strong>Accidental Release Measures<\/strong> &ndash; Guides spill containment, cleanup, and environmental precautions.<\/li>\n<li><strong>Handling and Storage<\/strong> &ndash; Defines safe handling practices and storage conditions.<\/li>\n<li><strong>Exposure Controls\/Personal Protection<\/strong> &ndash; Specifies PPE, ventilation, and exposure limits.<\/li>\n<li><strong>Physical and Chemical Properties<\/strong> &ndash; Lists appearance, solubility, boiling point, and other key data.<\/li>\n<li><strong>Stability and Reactivity<\/strong> &ndash; Describes chemical stability and incompatible conditions or materials.<\/li>\n<li><strong>Toxicological Information<\/strong> &ndash; Summarizes health effects and toxicological data from studies.<\/li>\n<li><strong>Ecological Information<\/strong> &ndash; Provides environmental impact, persistence, and bioaccumulation potential.<\/li>\n<li><strong>Disposal Considerations<\/strong> &ndash; Recommend safe disposal methods for substances and containers.<\/li>\n<li><strong>Transport Information<\/strong> &ndash; Gives UN numbers, hazard classes, and shipping regulations.<\/li>\n<li><strong>Regulatory Information<\/strong> &ndash; Identifies applicable chemical safety and regulatory frameworks.<\/li>\n<\/ol>\n<h2><strong>How Does the SDS Process Work in Pharma Supply Chains?<\/strong><\/h2>\n<ol>\n<li><strong>Preparation by Manufacturer<\/strong>: Chemical suppliers prepare SDSs based on testing, classification, and hazard data.<\/li>\n<li><strong>Distribution to Customers<\/strong>: An SDS must be provided with the first shipment of any hazardous material.<\/li>\n<li><strong>Updating &amp; Compliance<\/strong>: SDSs must be updated when new hazard information becomes available.<\/li>\n<li><strong>Integration into QMS<\/strong>: Companies archive SDSs for audits and workplace training programs.<\/li>\n<\/ol>\n<h2><strong>What Are Real-World Scenarios of SDS Usage in Pharma?<\/strong><\/h2>\n<ul>\n<li><strong>API Supply<\/strong>: A supplier provides SDS for a newly synthesized API, highlighting toxicity, handling, and storage controls.<\/li>\n<li><strong><a href=\"https:\/\/pharmint.net\/zh\/glossary\/excipient\/\" target=\"_self\" title=\"What is an Excipient? An&nbsp;excipient&nbsp;is an inactive substance used alongside the Active Pharmaceutical Ingredient (API) in a pharmaceutical formulation. Though excipients have no therapeutic effect, they play essential roles in drug delivery, stability, solubility, taste masking, and manufacturing processability. They are chemically stable and pharmaceutically inert but must meet stringent quality and safety standards. Why&hellip;\" class=\"encyclopedia\">Excipient<\/a> Procurement<\/strong>: Buyers receive SDS with <a href=\"https:\/\/pharmint.net\/zh\/glossary\/excipient\/\" target=\"_self\" title=\"What is an Excipient? An&nbsp;excipient&nbsp;is an inactive substance used alongside the Active Pharmaceutical Ingredient (API) in a pharmaceutical formulation. Though excipients have no therapeutic effect, they play essential roles in drug delivery, stability, solubility, taste masking, and manufacturing processability. They are chemically stable and pharmaceutically inert but must meet stringent quality and safety standards. Why&hellip;\" class=\"encyclopedia\">excipient<\/a>s to confirm safety data before GMP qualification.<\/li>\n<li><strong>Lab &amp; Production Safety<\/strong>: Operators use SDS for solvent spill response and PPE requirements.<\/li>\n<li><strong>Regulatory Audits<\/strong>: Inspectors review SDS archives to confirm hazard communication compliance.<\/li>\n<\/ul>\n<h2><strong>What Terms Are Related to SDS?<\/strong><\/h2>\n<ul>\n<li><strong><a href=\"https:\/\/pharmint.net\/zh\/glossary\/material-safety-data-sheet-msds\/\" target=\"_self\" title=\"What Is an MSDS (Material Safety Data Sheet)? An&nbsp;MSDS (Material Safety Data Sheet)&nbsp;is the&nbsp;older format&nbsp;of chemical hazard documentation that was widely used before the adoption of the&nbsp;GHS (Globally Harmonized System). It provided information about a chemical&rsquo;s hazards, handling, storage, and emergency response. Since 2012&ndash;2015, MSDS has been replaced globally by the standardized&nbsp;SDS (Safety Data Sheet)&nbsp;format.&hellip;\" class=\"encyclopedia\">MSDS (Material Safety Data Sheet)<\/a><\/strong>&nbsp;&ndash; pre-GHS legacy version<\/li>\n<li><strong>GHS (Globally Harmonized System)<\/strong>&nbsp;&ndash; global standard for hazard communication<\/li>\n<li><strong><a href=\"https:\/\/pharmint.net\/zh\/glossary\/reach-compliance\/\" target=\"_self\" title=\"What Is REACH Compliance? REACH&nbsp;stands for&nbsp;Registration, Evaluation, Authorization, and Restriction of Chemicals&mdash;a comprehensive EU chemicals regulation (EC No 1907\/2006) that came into force on 1 June 2007. It governs how chemical substances are manufactured, imported, and used in the EU, and seeks to protect human health and the environment. Who Must Comply with REACH in&hellip;\" class=\"encyclopedia\">REACH Compliance<\/a><\/strong>&nbsp;&ndash; EU chemical safety regulation requiring SDS submissions<\/li>\n<li><strong>Hazard Communication Standard (HCS)<\/strong>&nbsp;&ndash; OSHA regulation mandating SDS<\/li>\n<li><strong>Extended SDS (e-SDS)<\/strong>&nbsp;&ndash; REACH-specific SDS with exposure scenarios<\/li>\n<\/ul>\n<h2><strong>Safety Data Sheet FAQs&nbsp;<\/strong><\/h2>\n<h4><strong>Is an SDS mandatory for all chemicals in pharma?<\/strong><\/h4>\n<p>Yes. SDS must accompany any hazardous chemical used in R&amp;D, manufacturing, or storage, including APIs, solvents, and intermediates.<\/p>\n<h4><strong>How is SDS different from MSDS?<\/strong><\/h4>\n<p>An MSDS varied in format; SDS follows the&nbsp;<strong>GHS 16-section standardized format<\/strong>, ensuring global consistency.<\/p>\n<h4><strong>How often must SDS be updated?<\/strong><\/h4>\n<p>SDS must be updated immediately when new hazard or regulatory data emerges, typically reviewed every 3&ndash;5 years.<\/p>\n<h4><strong>Do excipients also require SDS?<\/strong><\/h4>\n<p>Yes. Even generally safe <a href=\"https:\/\/pharmint.net\/zh\/glossary\/excipient\/\" target=\"_self\" title=\"What is an Excipient? An&nbsp;excipient&nbsp;is an inactive substance used alongside the Active Pharmaceutical Ingredient (API) in a pharmaceutical formulation. Though excipients have no therapeutic effect, they play essential roles in drug delivery, stability, solubility, taste masking, and manufacturing processability. They are chemically stable and pharmaceutically inert but must meet stringent quality and safety standards. Why&hellip;\" class=\"encyclopedia\">excipient<\/a>s require SDS to document&nbsp;<strong>identity, storage, and hazard-free handling<\/strong>.<\/p>\n<h4><strong>Can SDS be digital?<\/strong><\/h4>\n<p>Yes. Electronic SDS (e-SDS) is widely accepted, provided they are accessible, compliant, and retrievable for audits.<\/p>\n","protected":false},"author":7806,"template":"","meta":{"rank_math_lock_modified_date":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"default","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ep_exclude_from_search":false},"encyclopedia-tag":[1264,1263,1268,1266,1262,1267,1261,1265],"class_list":["post-1739163","encyclopedia","type-encyclopedia","status-publish","hentry","encyclopedia-tag-chemical-safety-sheet","encyclopedia-tag-ghs-sds","encyclopedia-tag-gmp-safety","encyclopedia-tag-pharmaceutical-sds","encyclopedia-tag-safety-data-sheet","encyclopedia-tag-sds-compliance","encyclopedia-tag-sds-pharma","encyclopedia-tag-sds-vs-msds"],"_links":{"self":[{"href":"https:\/\/pharmint.net\/zh\/wp-json\/wp\/v2\/encyclopedia\/1739163","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmint.net\/zh\/wp-json\/wp\/v2\/encyclopedia"}],"about":[{"href":"https:\/\/pharmint.net\/zh\/wp-json\/wp\/v2\/types\/encyclopedia"}],"author":[{"embeddable":true,"href":"https:\/\/pharmint.net\/zh\/wp-json\/wp\/v2\/users\/7806"}],"wp:attachment":[{"href":"https:\/\/pharmint.net\/zh\/wp-json\/wp\/v2\/media?parent=1739163"}],"wp:term":[{"taxonomy":"encyclopedia-tag","embeddable":true,"href":"https:\/\/pharmint.net\/zh\/wp-json\/wp\/v2\/encyclopedia-tag?post=1739163"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}