{"id":44477,"date":"2017-11-21T17:51:16","date_gmt":"2017-11-21T21:51:16","guid":{"rendered":"https:\/\/caireadydev1.wpenginepowered.com\/life-sciences\/cai-implementing-usp-visual-inspection-requirements\/"},"modified":"2025-06-21T17:55:08","modified_gmt":"2025-06-21T21:55:08","slug":"implementing-usp-visual-inspection-requirements","status":"publish","type":"post","link":"https:\/\/caiready.com\/life-sciences\/blog\/implementing-usp-visual-inspection-requirements\/","title":{"rendered":"Implementing USP Visual Inspection Requirements"},"content":{"rendered":"<p><span>The word \u201cvisible\u201d in the expression<\/span><span>,<\/span><em> Visual Inspection of Parenteral Products<\/em><span>,<\/span><span> has no meaning unless the viewing conditions are specified.&nbsp;<\/span><\/p>\n<p> <!--more--> <\/p>\n<p><span><img decoding=\"async\" src=\"https:\/\/cdn2.hubspot.net\/hubfs\/705173\/BioPharm%20-17%20(1).jpg\" alt=\"BioPharma-17\" width=\"3491\" style=\"width: 3491px;\"><\/span><\/p>\n<p><span><span>The development of the <\/span><\/span><span><span>somewh<\/span><\/span><span><span>at <\/span><\/span><span><span>recently <\/span><\/span><span><span>implemented <\/span><\/span><span><span>USP Gen<\/span><\/span><span><span>eral Chapter &lt;<\/span><\/span><span><span>790<\/span><\/span><i><span><span>&gt;<\/span><\/span><\/i><i><span><span>, Visual Inspections in Injections<\/span><\/span><\/i><span><span>, <\/span><\/span><span><span>w<\/span><\/span><span><span>as<\/span><\/span><span><span> undertaken to address this gap in information<\/span><\/span><span><span>.<\/span><\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><span style=\"font-size: 1.8rem;\">Information <\/span><span style=\"font-size: 1.8rem;\">Chapter<\/span><span style=\"font-size: 1.8rem;\"> USP <\/span><span style=\"font-size: 1.8rem;\">&lt;1790&gt;<\/span><span style=\"font-size: 1.8rem;\">,<\/span> <i style=\"font-size: 1.8rem;\">Visible Particulates and Injections,<\/i> <span style=\"font-size: 1.8rem;\">was also prepared to provide further guidance in this area<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\" style=\"font-size: 1.8rem;\">&nbsp;.<\/span><\/p>\n<p><span><span>It is important to remember that <\/span><\/span><span><span>USP <\/span><\/span><span><span>General C<\/span><\/span><span><span>hapters<\/span><\/span><span><span>, <\/span><\/span><span><span>those with numbers below 1000<\/span><\/span><span><span> (USP&lt;790&gt;)<\/span><\/span><span><span> are enforceable by the FDA<\/span><\/span><span><span> and <\/span><\/span><span><span>compliance is expected<\/span><\/span><span><span>.&nbsp; I<\/span><\/span><span><span>nformation<\/span><\/span><span><span>al USP <\/span><\/span><span><span>chapters<\/span><\/span><span><span>,<\/span><\/span><span><span> with numbers of 1000 and above<\/span><\/span><span><span> (USP &lt;1790&gt;), <\/span><\/span><span><span>are meant as guidance and are written to support successful implementation of <\/span><\/span><span><span>the <\/span><\/span><span><span>General C<\/span><\/span><span><span>hapters<\/span><\/span><span><span>.<\/span><\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/p>\n<p><span><span>Despite the<\/span><\/span><span><span>se<\/span><\/span><span><span> new USP Chapters, there is still confusion in the industry concerning the requirements of Visual Inspection and the implementation of an inspection system compl<\/span><\/span><span><span>iant<\/span><\/span><span><span> with USP &lt;790&gt;.<\/span><\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/p>\n<p><span><span>In <\/span><\/span><span><span>a 2014<\/span><\/span><span><span> publication and seminars, John<\/span><\/span> <span><span>Shabushnig<\/span><\/span><span><span>, PhD<\/span><\/span><span><span>, one of the leaders of the committee that wrote the new USP Chapters on Visual Inspection, <\/span><\/span><span><span>highlighted the intent and changes <\/span><\/span><span><span>in USP &lt;790&gt; and &lt;1790&gt;.<\/span><\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/p>\n<p><span><span>&#8220;The intent of USP <\/span><\/span><span><span>General Chapter &lt;<\/span><\/span><span><span>790<\/span><\/span><span><span>&gt;<\/span><\/span> <span><span>was to move towards a global standard to define what is visible by d<\/span><\/span><span><span>efining<\/span><\/span><span><span> a common set of inspection conditions:<\/span><\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:720,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span><span>An inspection <\/span><\/span><span><span>l<\/span><\/span><span><span>ight<\/span><\/span><span><span> intensity of 200<\/span><\/span><span><span>0 to <\/span><\/span><span><span>3750<\/span><\/span><span><span> LUX<\/span><\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span><span>I<\/span><\/span><span><span>nspection for five seconds against black and white backgrounds<\/span><\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-aria-posinset=\"2\" data-aria-level=\"2\"><span><span>T<\/span><\/span><span><span>he container should be swirled or inverted<\/span><\/span><span><span> during the inspection provided that this does not damage the product.<\/span><\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-aria-posinset=\"3\" data-aria-level=\"2\"><span><span>N<\/span><\/span><span><span>o magnification <\/span><\/span><span><span>requirement is specified<\/span><\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-aria-posinset=\"4\" data-aria-level=\"2\"><span><span>The inspection processes<\/span><\/span><span><span> appl<\/span><\/span><span><span>ies <\/span><\/span><span><span>to extrinsic (coming from outside of the process) and intrinsic (coming from processing equipment and the primary packaging)<\/span><\/span><span><span>.<\/span><\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-aria-posinset=\"5\" data-aria-level=\"2\"><span><span>In the special case of <\/span><\/span><span><span>inherent particles<\/span><\/span><span><span>,<\/span><\/span><span><span> such as protein agglomerates<\/span><\/span><span><span>, <\/span><\/span><span><span>individual monographs <\/span><\/span><span><span>may need to be developed and included <\/span><\/span><span><span>and approved <\/span><\/span><span><span>in the <\/span><\/span><span><span>regulatory filing<\/span><\/span><span><span> for the product.<\/span><\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"4\" data-aria-posinset=\"1\" data-aria-level=\"2\"><span><span>Defines the <\/span><\/span><span><span>use of accepting sampling <\/span><\/span><span><span>for <\/span><\/span><span><span>batch release<\/span><\/span><span><span>,<\/span><\/span><span><span> after 100% inspection<\/span><\/span><span><span>,<\/span><\/span><span><span> u<\/span><\/span><span><span>sing a General L<\/span><\/span><span><span>evel II sampling plan from A<\/span><\/span><span><span>NSI\/ASQ Z1 .4 standard with an A<\/span><\/span><span><span>QL of 0.65%<\/span><\/span><span><span>.&nbsp; I<\/span><\/span><span><span>SO 2859 also provides an equivalent sampling plan.<\/span><\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;&#8220;<\/span><\/li>\n<\/ul>\n<p><span><span>To support the implementation of USP <\/span><\/span><span><span>&lt;790&gt;, the USP I<\/span><\/span><span><span>nformation <\/span><\/span><span><span>C<\/span><\/span><span><span>hapter <\/span><\/span><span><span>&lt;<\/span><\/span><span><span>1790<\/span><\/span><span><span>&gt;<\/span><\/span> <span><span>Visible Particulates and Injections<\/span><\/span> <span><span>was written. <\/span><\/span><span><span>The scope of USP <\/span><\/span><span><span>&lt;<\/span><\/span><span><span>1790&gt; <\/span><\/span><span><span>includes manual inspection but also extends to other visible defects such as container integrity and other inspection methods such as semi<\/span><\/span><span><span> &#8211; <\/span><\/span><span><span>automated and automated systems<\/span><\/span><span><span>.&nbsp; <\/span><\/span><span><span>USP &lt;1790&gt; provides the following information:<\/span><\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span><span>I<\/span><\/span><span><span>ntroduces the concept of the inspection lifecycle to help identify type<\/span><\/span><span><span>s of particulates <\/span><\/span><span><span>and <\/span><\/span><span><span>their <\/span><\/span><span><span>source with the goal of continuous improvement <\/span><\/span><span><span>and reduction in particulates throughout the process.&nbsp;<\/span><\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span><span>P<\/span><\/span><span><span>rovides more detailed discussion on the risk of particulates to patients<\/span><\/span><span><span> to aid in risk assessments.&nbsp;<\/span><\/span><span><span>&nbsp;<\/span><\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/li>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"5\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span><span>P<\/span><\/span><span><span>rovides recommendations and methods <\/span><\/span><span><span>for<\/span><\/span> <span><span>the proper preparation of test sets to assess manual inspection performance and to qualify inspectors<\/span><\/span><span><span>.&nbsp; These procedures may<\/span><\/span> <span><span>be <\/span><\/span><span><span>applied to the qualification and validation of semi<\/span><\/span><span><span>&#8211;<\/span><\/span><span><span>automated and automated inspection processes<\/span><\/span><span><span>.&nbsp;&nbsp;<\/span><\/span><span data-ccp-props=\"{&quot;134233279&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">&nbsp;<\/span><\/li>\n<\/ul>\n<p><span><span>A trusted partner firm with solid <\/span><\/span><span><span>visual inspection and <\/span><\/span><span><span>quality system procedures can be invaluable in supporting your organization <\/span><\/span><span><span>when establishing your visual inspection program and validating the inspection processes.&nbsp;<\/span><\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">&nbsp;<\/span><\/p>\n<p><span><span>When you need to meet a higher standard and deliver quality products for your stakeholders and patients, select CAI as your trusted advisor to take you from molecule to Full Scale Operations.<\/span><\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:240}\">&nbsp; <a href=\"http:\/\/info.commissioningagents.com\/contact\" target=\"_blank\" rel=\"noopener noreferrer nofollow\">Contact us<\/a> to find out more.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The word \u201cvisible\u201d in the expression, Visual Inspection of Parenteral Products, has no meaning unless the viewing conditions are specified.&nbsp;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[121],"tags":[],"resource-featured-status":[],"resource-type":[819],"class_list":["post-44477","post","type-post","status-publish","format-standard","hentry","category-operations-and-regulatory-consulting-quality-compliance-regulatory","resource-type-blog"],"acf":[],"featured_image_src":null,"featured_image_src_square":null,"author_info":{"display_name":"mikeviele","author_link":"https:\/\/caiready.com\/life-sciences\/blog\/author\/mikeviele\/"},"_links":{"self":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts\/44477","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/comments?post=44477"}],"version-history":[{"count":0,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/posts\/44477\/revisions"}],"wp:attachment":[{"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/media?parent=44477"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/categories?post=44477"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/tags?post=44477"},{"taxonomy":"resource-featured-status","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-featured-status?post=44477"},{"taxonomy":"resource-type","embeddable":true,"href":"https:\/\/caiready.com\/life-sciences\/wp-json\/wp\/v2\/resource-type?post=44477"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}