{"id":8186,"date":"2024-01-12T16:45:56","date_gmt":"2024-01-12T16:45:56","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8186"},"modified":"2024-01-12T19:54:23","modified_gmt":"2024-01-12T19:54:23","slug":"pharma-process-validation-where-do-we-start","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/pharma-process-validation-where-do-we-start\/","title":{"rendered":"Pharma Process Validation: Where Do We Start?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8186\" class=\"elementor elementor-8186\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4264d41\" data-id=\"4264d41\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2024\/01\/12\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tJanuary 12, 2024\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">Pharma Process Validation: Where Do We Start?<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"300\" height=\"200\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/blue-white-capsules-and-pharma-manufacturing-300x200-1.jpeg\" class=\"attachment-full size-full wp-image-5203\" alt=\"\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>The entire purpose of conducting validation is to build quality, safety, and effectiveness into the finished pharmaceutical, and not to rely on post-production batch testing. To accomplish this, you need to make sure that every process step performs as expected based on quality design, with the ultimate goal being consistent reproducibility. This process of validation is ongoing and conducted throughout the life cycle of the product, from development through commercial manufacturing.<\/p><p>\u00a0<\/p><h3>It All Starts with a Validation Master Plan (VMP)<\/h3><p>Validation is not something you start and then figure out as you go; it\u2019s complicated, and starting the process without a solid plan would be like wandering into the wilderness without a compass, water, or food. A validation master plan shows the interrelationships among processes and helps you plan resources and estimate costs, including those for external resources. A detailed VMP includes comprehensive lists of manufacturing equipment, testing equipment, special requirements, required documents, and more. Among other things, it also ties together all protocols necessary to complete the validation project and should clearly communicate the company\u2019s intent to start production using the new process or equipment in a fully compliant state. It is important that senior management approves the validation plan so that they fully understand the scope of the effort before work begins. Creating a VMP checklist is a smart way to begin.<\/p><p>\u00a0<\/p><h3>Types of Process Validation in Pharma<\/h3><p><strong>1. Design qualification (DQ)<\/strong>\u00a0\u2013 Documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose.<\/p><p><strong>2. Installation qualification (IQ)<\/strong>\u00a0\u2013 Documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer\u2019s recommendations, and\/or user requirements.<\/p><p><strong>3. Operational qualification (OQ)<\/strong>\u00a0\u2013 Documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges.<\/p><p><strong>4. Process performance qualification (PQ<\/strong><strong>)<\/strong>\u00a0\u2013 Documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications.<\/p><h3>\u00a0<\/h3><h3>Three Stages of Pharma Process Validation<\/h3><p>Process validation begins by designing and\/or understanding the commercial process used to manufacture your product. During this stage, your goal is to clearly define a process that is suitable for routine commercial manufacturing, delivers a product consistently, and meets its quality attributes. This stage will inevitably require you to run experiments and simulations. Regardless of what types of simulations you run, you must understand the degree to which your models represent the commercial process and try to predict the performance of it. Any protocols you conduct should use solid scientific methods and be well documented.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter wp-image-5204 size-full lazy loaded\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-stages-e1663683878527.png\" sizes=\"(max-width: 500px) 100vw, 500px\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-stages-e1663683878527.png 500w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-stages-e1663683878527-300x220.png 300w\" alt=\"\" width=\"500\" height=\"366\" data-src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-stages-e1663683878527.png\" data-srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-stages-e1663683878527.png 500w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-stages-e1663683878527-300x220.png 300w\" data-sizes=\"(max-width: 500px) 100vw, 500px\" data-was-processed=\"true\" \/><\/p><div class=\"table-responsive\"><table class=\"table table_blog\"><tbody><tr><td><strong>Stage 1: Process Design\u00a0<\/strong>Based on knowledge gained during development and scale-up activities, the commercial process is established.<\/td><td><strong>Stage 2: Process Qualification\u00a0<\/strong>Process design is evaluated to determine if it is capable of commercial manufacturing that is reproducible.<\/td><\/tr><\/tbody><\/table><\/div><h3>\u00a0<\/h3><h3>EU and FDA Regulations Governing Process Validation<\/h3><p>There are a host of documents you need to gather in order to get a better understanding of what\u2019s required for pharmaceutical process validation. Below we\u2019ve listed the most commonly applied US and European regulations and guidance, plus international guidelines you will need to follow.<\/p><p>\u00a0<\/p><div class=\"table-responsive\"><table class=\"table table-bordered table_blog\"><thead><tr class=\"tcolor_blue\"><th>\u00a0<\/th><th>US Food and Drug Administration (FDA)<\/th><th>European Medicines Agency (EMA)<\/th><\/tr><\/thead><tbody><tr><td bgcolor=\"#bbd2e8\"><strong>Regulations<\/strong><\/td><td>FDA 21 CFR Parts 210 and 211 include prescriptive requirements for documentation of validation activities.\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-210\" target=\"_blank\" rel=\"noopener noreferrer\">Part 210<\/a>\u00a0deals with the manufacturing, processing, packing, or holding of drugs, while\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-C\/part-211\" target=\"_blank\" rel=\"noopener noreferrer\">Part 211<\/a>\u00a0deals with finished pharmaceuticals and is the foundation for process validation.<\/td><td width=\"303\"><a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en\" target=\"_blank\" rel=\"noopener noreferrer\">Volume 4<\/a>, Annex 15 of \u201cThe rules governing medicinal products in the European Union,\u201d is a 2015 guidance published by the European Commission covering\u00a0<a href=\"https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en#:~:text=Qualification%20and%20validation\" target=\"_blank\" rel=\"noopener noreferrer\">principles of qualification and validation for the manufacture of medicinal products<\/a><\/td><\/tr><tr><td bgcolor=\"#bbd2e8\"><strong>Guidance<\/strong><\/td><td><p>You\u2019ll also want to download the 2011\u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/process-validation-general-principles-and-practices\" target=\"_blank\" rel=\"noopener noreferrer\">guidance document on pharma process validation<\/a>\u00a0published by FDA.<\/p><p>It covers:<\/p><ul><li>Human drugs<\/li><li>Biological and biotech products<\/li><li>Finished products and active pharmaceutical ingredients<\/li><li>Drug portion of a combination device<\/li><\/ul><\/td><td><ul><li><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-process-validation-finished-products-information-data-be-provided-regulatory-submissions_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Guideline on process validation for finished products \u2013 information and data to be provided in regulatory submissions<\/a><\/li><li><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/note-guidance-process-validation_en.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">Note for Guidance on Process Validation<\/a><\/li><li><a href=\"https:\/\/www.ema.europa.eu\/en\/ich-q7-good-manufacturing-practice-active-pharmaceutical-ingredients\" target=\"_blank\" rel=\"noopener noreferrer\">ICH Q7 Good manufacturing practice guidance for active pharmaceutical ingredients (guidance for industry)<\/a><\/li><\/ul><\/td><\/tr><\/tbody><\/table><\/div><p><strong>What is the difference between pharmaceutical\u00a0<em>validation<\/em>\u00a0and\u00a0<em>qualification?<\/em><\/strong><\/p><p>These often get confused.\u00a0<em>Qualification<\/em>\u00a0is a subset of\u00a0<em>validation<\/em>. It is smaller in scope, more static in nature, and often includes tests performed on a single element or component of the pharmaceutical process.<\/p><h3>\u00a0<\/h3><h3>Assemble Your Pharma Validation Team<\/h3><p>Pharma process validation isn\u2019t a solo project. You need to get input from experts who know the drug and production process inside and out. Typically, your team will include members from quality assurance, engineering, industrial pharmacy, analytical chemistry, microbiology, and manufacturing. However, if your company is larger, it may also include people working in R&amp;D, clinical engineering, purchasing, lab\/technical services, or regulatory. Resist the urge to make the team larger than it should be. To keep things efficient, add people carefully, ensuring they have expertise in the process and can add significant value to the team. Below is an example of the team structure. Roles and responsibilities should be laid out in the validation master file.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter wp-image-5206 size-full lazy loaded\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-team-1024x559-1.png\" sizes=\"(max-width: 1024px) 100vw, 1024px\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-team-1024x559-1.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-team-1024x559-1-300x164.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-team-1024x559-1-768x419.png 768w\" alt=\"\" width=\"1024\" height=\"559\" data-src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-team-1024x559-1.png\" data-srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-team-1024x559-1.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-team-1024x559-1-300x164.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/process-validation-team-1024x559-1-768x419.png 768w\" data-sizes=\"(max-width: 1024px) 100vw, 1024px\" data-was-processed=\"true\" \/><\/p><h3>\u00a0<\/h3><h3>Go Deep on Validation<\/h3><p>Reading and doing are two entirely different things. If you are to be tasked with \u201cdoing\u201d an actual validation project, consider our\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/process-validation-pharmaceutical-training#tabs2-tab\" target=\"_blank\" rel=\"noopener noreferrer\">pharma validation training class<\/a>. You\u2019ll get an in-depth look at the entire pharmaceutical validation cycle, writing protocols, determining key operating parameters, establishing ranges for critical quality attributes, and identifying data analysis strategies. 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href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Pharma Process Validation: Where Do We Start? The entire purpose of conducting validation is to build quality, safety, and effectiveness into the finished pharmaceutical, and not to rely on post-production batch testing. To accomplish this, you need to make sure that every process step performs as expected based on quality design, with the ultimate goal [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5203,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[58,35],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/pharma-process-validation-where-do-we-start\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Pharma Process Validation: Where Do We Start? The entire purpose of conducting validation is to build quality, safety, and effectiveness into the finished pharmaceutical, and not to rely on post-production batch testing. To accomplish this, you need to make sure that every process step performs as expected based on quality design, with the ultimate goal [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/pharma-process-validation-where-do-we-start\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2024-01-12T16:45:56+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-12T19:54:23+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/blue-white-capsules-and-pharma-manufacturing-300x200-1.jpeg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"300\" \/>\r\n\t<meta property=\"og:image:height\" content=\"200\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\r\n<meta name=\"author\" content=\"usr192162\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"usr192162\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog","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.orielstat.com\/blog\/pharma-process-validation-where-do-we-start\/","og_locale":"en_US","og_type":"article","og_description":"Pharma Process Validation: Where Do We Start? 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