{"id":1981,"date":"2020-10-24T18:27:55","date_gmt":"2020-10-24T18:27:55","guid":{"rendered":"https:\/\/iqm-consulting.com\/?p=1981"},"modified":"2020-10-24T19:12:10","modified_gmt":"2020-10-24T19:12:10","slug":"foreign-vs-domestic-fda-inspection-is-it-expected-to-be-approached-in-the-same-manner","status":"publish","type":"post","link":"https:\/\/iqm-consulting.com\/index.php\/2020\/10\/24\/foreign-vs-domestic-fda-inspection-is-it-expected-to-be-approached-in-the-same-manner\/","title":{"rendered":"Foreign vs. Domestic FDA inspection. Is it expected to be approached in the same manner?"},"content":{"rendered":"\n

The FDA in his reference document for FDA Investigators, GUIDE TO INSPECTIONS OF FOREIGN PHARMACEUTICAL MANUFACTURERS\u201d, said that \u201cOne main difference that poses a significant challenge to the inspection team abroad is the logistics borne by the program itself.\u201d See  <\/em>https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-guides\/foreign-pharmaceutical-manufacturers-596#Note<\/em><\/a><\/p>\n\n\n\n

Therefore, how do foreign manufacturers have to prepare a FDA inspection? An audit is mainly a communication process between auditor and auditee, with a close and continuous interaction between people, therefore there is significant subjective factor during an inspection.<\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

Foreign manufacturers have to recognize this subjective factor to have a positive atmosphere during inspection.<\/p>\n\n\n\n

Foreign manufacturers have to feel real empathy with inspectors, they are alone thousands of miles away, in a foreign country with different culture, language and social behaviours, so it is on foreign manufacturers hands, make the logistics borne is not a significant challenge for them.<\/p>\n\n\n\n

There are some simple tips to create this emphatic approach, taking care of:<\/p>\n\n\n\n

Accommodation: Propose some hotels in a safe place with some activities (walking, interesting places for visiting, restaurants,…) in the evening. Hotels located in industrial parks is not the best option for foreign visitors.<\/p>\n\n\n\n

Prior inspection, ask if they have some dietary restrictions or they do not like some type of foods or drinks. It is better to know they are vegans in advance, no just the first day at lunch in front of a bloody hamburger!!!<\/p>\n\n\n\n

Propose a daily brief lunch break at the inspection room to optimize inspection time. Spend 2-3 hours in the best restaurant in town centre maybe it is not a good option.<\/p>\n\n\n\n

Ground transportation: Propose daily pickup at hotel during inspection and plan pickup at airport. It is a recommended practice to have a first contact in a relaxing place, doing they feel safe in a foreign country with different language and currency. Arriving of inspectors at site after a strong discussion with local taxi drivers about fees, spending time, or basic understanding does not help to create a positive atmosphere.<\/p>\n\n\n\n

Personal safety in foreign manufacturers country: Provide a 24\/7 personnel mobile number to call is case of emergency, inform them about safe and unsafe places in your town or area, paid attention to their healthy conditions, provide medical assistance if they require\u2026.<\/p>\n\n\n\n

Topics to talk about: During inspection, nothing is ‘off the record’, so be prepared to talk about some topics during relaxing time, coffee or lunch break, \u2026.Maybe you could get some topics for chatting from their social networks or interesting groups.<\/p>\n\n\n\n

IQM-Consulting<\/a> also helps foreign manufacturers to handling the subjective process inherent to the human relationship established during audit.<\/p>\n","protected":false},"excerpt":{"rendered":"

The FDA in his reference document for FDA Investigators, GUIDE TO INSPECTIONS OF FOREIGN PHARMACEUTICAL MANUFACTURERS\u201d, said that \u201cOne main difference that poses a significant challenge to the inspection team abroad is the logistics borne by the program itself.\u201d See  https:\/\/www.fda.gov\/inspections-compliance-enforcement-and-criminal-investigations\/inspection-guides\/foreign-pharmaceutical-manufacturers-596#Note Therefore, how do foreign manufacturers have to prepare a FDA inspection? An audit is mainly […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"","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":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","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-opacity":"","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-opacity":"","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-opacity":"","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-opacity":"","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-opacity":"","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-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/posts\/1981"}],"collection":[{"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/comments?post=1981"}],"version-history":[{"count":1,"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/posts\/1981\/revisions"}],"predecessor-version":[{"id":1983,"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/posts\/1981\/revisions\/1983"}],"wp:attachment":[{"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/media?parent=1981"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/categories?post=1981"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/iqm-consulting.com\/index.php\/wp-json\/wp\/v2\/tags?post=1981"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}