{"id":4215,"date":"2017-10-02T02:35:56","date_gmt":"2017-10-01T23:05:56","guid":{"rendered":"https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/"},"modified":"2017-10-02T02:35:56","modified_gmt":"2017-10-01T23:05:56","slug":"frequently-asked-questions","status":"publish","type":"page","link":"https:\/\/shimisanj.com\/en\/about-company\/frequently-asked-questions\/","title":{"rendered":"Frequently Asked Questions"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_single_image image=&#8221;3143&#8243; img_size=&#8221;1280&#215;500&#8243;][vc_empty_space height=&#8221;40px&#8221;][vc_row_inner][vc_column_inner][vc_column_text]Our expertise lies in calibration, qualification, drug analysis and secondary standard production. Below you can find the most frequently asked questions and answers. If you do not find your answer, be sure to contact us. [\/vc_column_text][vc_empty_space height=&#8221;40px&#8221;][\/vc_column_inner][\/vc_row_inner][vc_toggle title=&#8221;What is equipment calibration and why is it important in the pharmaceutical industry?&#8221;]Calibration is the process of matching the accuracy of measuring equipment to reference standards. In the pharmaceutical industry, this process is critical because measurement errors can lead to the production of drugs that are out of specification (OOS) and endanger patient health. Regular calibration ensures that test results comply with <strong>GMP<\/strong>, <strong>ISO\/IEC 17025<\/strong> and <strong>USP<\/strong> requirements.  [\/vc_toggle][vc_toggle title=&#8221;What is the difference between equipment calibration and qualification?&#8221;]<\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>Calibration<\/strong>: Checking the accuracy of measuring equipment against known standards.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>\u0627\u062d\u0631\u0627\u0632 \u0635\u0644\u0627\u062d\u06cc\u062a (Qualification):<\/strong> \u0627\u062b\u0628\u0627\u062a \u0627\u06cc\u0646\u06a9\u0647 \u062a\u062c\u0647\u06cc\u0632\u0627\u062a \u062f\u0631 \u0645\u062d\u06cc\u0637 \u0639\u0645\u0644\u06cc\u0627\u062a\u06cc \u062e\u0627\u0635 (\u0645\u062b\u0644 \u0622\u0632\u0645\u0627\u06cc\u0634\u06af\u0627\u0647 \u062f\u0627\u0631\u0648\u0633\u0627\u0632\u06cc) \u0628\u0647\u0637\u0648\u0631 \u0635\u062d\u06cc\u062d \u0648 \u067e\u0627\u06cc\u062f\u0627\u0631 \u06a9\u0627\u0631 \u0645\u06cc\u06a9\u0646\u0646\u062f.<\/p>\n<\/li>\n<\/ul>\n<p>[\/vc_toggle][vc_toggle title=&#8221;What is the calibration process for chromatography devices (HPLC\/GC)?&#8221;]Calibration of these devices includes checking parameters such as pump flow accuracy, oven temperature accuracy, detector accuracy, and system linearity. Reference standards and <strong>FDA <\/strong>and <strong>ICH Q2<\/strong> protocols, etc. are used. A full calibration report is provided with details of errors and corrections.  [\/vc_toggle][vc_toggle title=&#8221;How often should equipment be calibrated?&#8221;]<\/p>\n<p class=\"ds-markdown-paragraph\">It depends on the type of equipment, usage, and legal requirements. <\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">Critical equipment (e.g. HPLC): annually or after each major overhaul. <\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">General equipment (e.g. scales): Every 6-12 months.<br \/>\nWe recommend a <strong>risk-based GAMP<\/strong> 5 schedule. <\/p>\n<\/li>\n<\/ul>\n<p>[\/vc_toggle][\/vc_column][\/vc_row][vc_row][vc_column][vc_toggle title=&#8221;What are the steps involved in qualifying general equipment (such as incubators or centrifuges)?&#8221;]<\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>IQ (Installation)<\/strong>: Ensuring correct installation and compliance with technical specifications.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>OQ (Operational):<\/strong> Testing performance within specified limits (e.g. temperature, speed).<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\"><strong>PQ (Performance): <\/strong>Simulate real-world operating conditions (such as loading samples) to prove system stability.<\/p>\n<\/li>\n<\/ul>\n<p>[\/vc_toggle][vc_toggle title=&#8221;What are the drug analysis methods in your company based on?&#8221;]We use <strong>USP<\/strong>, <strong>EP<\/strong> approved pharmacopoeias and even internal validated methods or customer suggested methods. All analysis documentation is provided to customers along with valid certificates. [\/vc_toggle][vc_toggle title=&#8221;What documents do we receive after calibration or qualification?&#8221;]<\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">Calibration certificate with details of errors, uncertainties, and reference standard.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">Qualification report (IQ\/OQ\/PQ) signed by the technical officer.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">Label on equipment with next calibration date.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">All documents comply with I<strong>SO 17025<\/strong> requirements and can be presented to inspectors of regulatory organizations.<\/p>\n<\/li>\n<\/ul>\n<p>[\/vc_toggle][\/vc_column][\/vc_row][vc_row][vc_column][vc_toggle title=&#8221;What actions do you take if equipment is outside the standard range?&#8221;]<\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">Declaration of &#8220;non-compliance&#8221; in the final report.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u067e\u06cc\u0634\u0646\u0647\u0627\u062f \u062a\u0639\u0645\u06cc\u0631 \u06cc\u0627 \u062a\u0646\u0638\u06cc\u0645 \u0645\u062c\u062f\u062f \u062a\u062c\u0647\u06cc\u0632\u0627\u062a.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">\u062f\u0631 \u0635\u0648\u0631\u062a \u0646\u06cc\u0627\u0632\u060c \u0627\u0631\u0627\u0626\u0647 \u062e\u062f\u0645\u0627\u062a \u0645\u0634\u0627\u0648\u0631\u0647 \u0628\u0631\u0627\u06cc \u062c\u0627\u06cc\u06af\u0632\u06cc\u0646\u06cc \u062a\u062c\u0647\u06cc\u0632\u0627\u062a<\/p>\n<\/li>\n<li>\u062f\u0631 \u0635\u0648\u0631\u062a \u062a\u0639\u0645\u06cc\u0631 \u062a\u062c\u0647\u06cc\u0632 \u0628\u0627\u0631 \u062f\u06cc\u06af\u0631 \u062a\u0648\u0633\u0637 \u0645\u0627 \u062e\u062f\u0645\u0627\u062a \u06a9\u0627\u0644\u06cc\u0628\u0631\u0627\u0633\u06cc\u0648\u0646 \u0628\u0647 \u0635\u0648\u0631\u062a \u0631\u0627\u06cc\u06af\u0627\u0646 \u0627\u0631\u0627\u06cc\u0647 \u0645\u06cc\u0634\u0648\u062f.<\/li>\n<\/ul>\n<p>[\/vc_toggle][vc_toggle title=&#8221;What are the factors affecting the cost of calibration and qualification?&#8221;]<\/p>\n<ul>\n<li>\n<p class=\"ds-markdown-paragraph\">Type and number of equipment.<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">Process complexity (e.g. chromatography devices are more expensive)<\/p>\n<\/li>\n<li>\n<p class=\"ds-markdown-paragraph\">Urgency of service (emergency services cost more)<\/p>\n<\/li>\n<\/ul>\n<p>[\/vc_toggle][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_single_image image=&#8221;3143&#8243; img_size=&#8221;1280&#215;500&#8243;][vc_empty_space height=&#8221;40px&#8221;][vc_row_inner][vc_column_inner][vc_column_text]Our expertise lies in calibration, qualification, drug analysis and secondary standard production. Below you can find the most frequently asked questions and answers. If you do not find your answer, be sure to contact us. [\/vc_column_text][vc_empty_space height=&#8221;40px&#8221;][\/vc_column_inner][\/vc_row_inner][vc_toggle title=&#8221;What is equipment calibration and why is it important in the pharmaceutical industry?&#8221;]Calibration is the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":4134,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4215","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.1 (Yoast SEO v25.2) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Frequently Asked Questions - \u0622\u0631\u0645\u0627\u0646 \u0634\u06cc\u0645\u06cc \u0633\u0646\u062c<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Frequently Asked Questions\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_single_image image=&#8221;3143&#8243; img_size=&#8221;1280&#215;500&#8243;][vc_empty_space height=&#8221;40px&#8221;][vc_row_inner][vc_column_inner][vc_column_text]Our expertise lies in calibration, qualification, drug analysis and secondary standard production. Below you can find the most frequently asked questions and answers. If you do not find your answer, be sure to contact us. [\/vc_column_text][vc_empty_space height=&#8221;40px&#8221;][\/vc_column_inner][\/vc_row_inner][vc_toggle title=&#8221;What is equipment calibration and why is it important in the pharmaceutical industry?&#8221;]Calibration is the [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/\" \/>\n<meta property=\"og:site_name\" content=\"\u0622\u0631\u0645\u0627\u0646 \u0634\u06cc\u0645\u06cc \u0633\u0646\u062c\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/\",\"url\":\"https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/\",\"name\":\"Frequently Asked Questions - \u0622\u0631\u0645\u0627\u0646 \u0634\u06cc\u0645\u06cc \u0633\u0646\u062c\",\"isPartOf\":{\"@id\":\"https:\/\/shimisanj.com\/#website\"},\"datePublished\":\"2017-10-01T23:05:56+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"\u062e\u0627\u0646\u0647\",\"item\":\"https:\/\/shimisanj.com\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"About Company\",\"item\":\"https:\/\/shimisanj.com\/en\/about-company\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Frequently Asked Questions\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/shimisanj.com\/#website\",\"url\":\"https:\/\/shimisanj.com\/\",\"name\":\"\u0622\u0631\u0645\u0627\u0646 \u0634\u06cc\u0645\u06cc \u0633\u0646\u062c\",\"description\":\"\u0627\u0631\u0627\u0626\u0647 \u062f\u0647\u0646\u062f\u0647 \u062e\u062f\u0645\u0627\u062a \u0633\u0637\u062d \u0628\u0627\u0644\u0627\u06cc \u06a9\u06cc\u0641\u06cc\",\"publisher\":{\"@id\":\"https:\/\/shimisanj.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/shimisanj.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/shimisanj.com\/#organization\",\"name\":\"\u0622\u0631\u0645\u0627\u0646 \u0634\u06cc\u0645\u06cc \u0633\u0646\u062c\",\"url\":\"https:\/\/shimisanj.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/shimisanj.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/shimisanj.com\/wp-content\/uploads\/2024\/08\/Shimisanj.jpg\",\"contentUrl\":\"https:\/\/shimisanj.com\/wp-content\/uploads\/2024\/08\/Shimisanj.jpg\",\"width\":350,\"height\":100,\"caption\":\"\u0622\u0631\u0645\u0627\u0646 \u0634\u06cc\u0645\u06cc \u0633\u0646\u062c\"},\"image\":{\"@id\":\"https:\/\/shimisanj.com\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/arman-shimisanj-co\/\",\"https:\/\/www.instagram.com\/arman_shimisanj?igsh=ZnBrMjB3cnM2NmN6\"]}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Frequently Asked Questions - \u0622\u0631\u0645\u0627\u0646 \u0634\u06cc\u0645\u06cc \u0633\u0646\u062c","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:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/","og_locale":"en_US","og_type":"article","og_title":"Frequently Asked Questions","og_description":"[vc_row][vc_column][vc_single_image image=&#8221;3143&#8243; img_size=&#8221;1280&#215;500&#8243;][vc_empty_space height=&#8221;40px&#8221;][vc_row_inner][vc_column_inner][vc_column_text]Our expertise lies in calibration, qualification, drug analysis and secondary standard production. Below you can find the most frequently asked questions and answers. If you do not find your answer, be sure to contact us. [\/vc_column_text][vc_empty_space height=&#8221;40px&#8221;][\/vc_column_inner][\/vc_row_inner][vc_toggle title=&#8221;What is equipment calibration and why is it important in the pharmaceutical industry?&#8221;]Calibration is the [&hellip;]","og_url":"https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/","og_site_name":"\u0622\u0631\u0645\u0627\u0646 \u0634\u06cc\u0645\u06cc \u0633\u0646\u062c","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/","url":"https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/","name":"Frequently Asked Questions - \u0622\u0631\u0645\u0627\u0646 \u0634\u06cc\u0645\u06cc \u0633\u0646\u062c","isPartOf":{"@id":"https:\/\/shimisanj.com\/#website"},"datePublished":"2017-10-01T23:05:56+00:00","breadcrumb":{"@id":"https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/shimisanj.com\/about-company\/frequently-asked-questions\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"\u062e\u0627\u0646\u0647","item":"https:\/\/shimisanj.com\/en\/"},{"@type":"ListItem","position":2,"name":"About Company","item":"https:\/\/shimisanj.com\/en\/about-company\/"},{"@type":"ListItem","position":3,"name":"Frequently Asked Questions"}]},{"@type":"WebSite","@id":"https:\/\/shimisanj.com\/#website","url":"https:\/\/shimisanj.com\/","name":"\u0622\u0631\u0645\u0627\u0646 \u0634\u06cc\u0645\u06cc \u0633\u0646\u062c","description":"\u0627\u0631\u0627\u0626\u0647 \u062f\u0647\u0646\u062f\u0647 \u062e\u062f\u0645\u0627\u062a \u0633\u0637\u062d \u0628\u0627\u0644\u0627\u06cc \u06a9\u06cc\u0641\u06cc","publisher":{"@id":"https:\/\/shimisanj.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/shimisanj.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/shimisanj.com\/#organization","name":"\u0622\u0631\u0645\u0627\u0646 \u0634\u06cc\u0645\u06cc \u0633\u0646\u062c","url":"https:\/\/shimisanj.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/shimisanj.com\/#\/schema\/logo\/image\/","url":"https:\/\/shimisanj.com\/wp-content\/uploads\/2024\/08\/Shimisanj.jpg","contentUrl":"https:\/\/shimisanj.com\/wp-content\/uploads\/2024\/08\/Shimisanj.jpg","width":350,"height":100,"caption":"\u0622\u0631\u0645\u0627\u0646 \u0634\u06cc\u0645\u06cc \u0633\u0646\u062c"},"image":{"@id":"https:\/\/shimisanj.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/arman-shimisanj-co\/","https:\/\/www.instagram.com\/arman_shimisanj?igsh=ZnBrMjB3cnM2NmN6"]}]}},"_links":{"self":[{"href":"https:\/\/shimisanj.com\/en\/wp-json\/wp\/v2\/pages\/4215"}],"collection":[{"href":"https:\/\/shimisanj.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/shimisanj.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/shimisanj.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/shimisanj.com\/en\/wp-json\/wp\/v2\/comments?post=4215"}],"version-history":[{"count":0,"href":"https:\/\/shimisanj.com\/en\/wp-json\/wp\/v2\/pages\/4215\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/shimisanj.com\/en\/wp-json\/wp\/v2\/pages\/4134"}],"wp:attachment":[{"href":"https:\/\/shimisanj.com\/en\/wp-json\/wp\/v2\/media?parent=4215"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}