{"id":32359,"date":"2021-05-21T05:19:58","date_gmt":"2021-05-21T05:19:58","guid":{"rendered":"https:\/\/www.inspirenignite.com\/anna-university\/opy752-regulatory-requirements-in-pharmaceutical-industries-syllabus-for-biomedical-7th-sem-2019-regulation-anna-university-open-elective-ii\/"},"modified":"2021-05-21T05:19:58","modified_gmt":"2021-05-21T05:19:58","slug":"opy752-regulatory-requirements-in-pharmaceutical-industries-syllabus-for-biomedical-7th-sem-2019-regulation-anna-university-open-elective-ii","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/anna-university\/opy752-regulatory-requirements-in-pharmaceutical-industries-syllabus-for-biomedical-7th-sem-2019-regulation-anna-university-open-elective-ii\/","title":{"rendered":"OPY752: Regulatory Requirements in Pharmaceutical Industries Syllabus for Biomedical 7th Sem 2019 Regulation Anna University (Open Elective-II)"},"content":{"rendered":"

Regulatory Requirements in Pharmaceutical Industries detailed syllabus for Biomedical Engineering (Biomedical) for 2019 regulation curriculum has been taken from the Anna Universities<\/a> official website and presented for the Biomedical students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below. <\/p>\n

For Biomedical Engineering 7th Sem scheme and its subjects, do visit Biomedical 7th Sem 2019 regulation scheme<\/a>. For Open Elective-II scheme and its subjects refer to Biomedical Open Elective-II syllabus scheme<\/a>. The detailed syllabus of regulatory requirements in pharmaceutical industries is as follows. <\/p>\n

Regulatory Requirements in Pharmaceutical Industries<\/title><\/p>\n<h4>Course Objective:<\/h4>\n<p id=\"istudy\" style=\"text-align:center\">For the complete syllabus, results, class timetable, and many other features kindly download the <a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">iStudy App<\/a><br \/><b> It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.<\/b><br \/><a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy&pcampaignid=pcampaignidMKT-Other-global-all-co-prtnr-py-PartBadge-Mar2515-1\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/play.google.com\/intl\/en_us\/badges\/static\/images\/badges\/en_badge_web_generic.png\" alt=\"Get it on Google Play\" style=\"height:65px\"><\/a>. <\/p>\n<h4>Unit I<\/h4>\n<p align=\"justify\">\n<p><strong>Regulatory Concepts<\/strong><br \/>\n Quality assurance – Quality control – Practice of cGMP – Schedule M – USFDA.<\/p>\n<\/p>\n<h4>Unit II<\/h4>\n<p id=\"istudy\" style=\"text-align:center\">For the complete syllabus, results, class timetable, and many other features kindly download the <a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">iStudy App<\/a><br \/><b> It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.<\/b><br \/><a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy&pcampaignid=pcampaignidMKT-Other-global-all-co-prtnr-py-PartBadge-Mar2515-1\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/play.google.com\/intl\/en_us\/badges\/static\/images\/badges\/en_badge_web_generic.png\" alt=\"Get it on Google Play\" style=\"height:65px\"><\/a>. <\/p>\n<h4>Unit III<\/h4>\n<p align=\"justify\">\n<p><strong>Intellectual Property Rights<\/strong><br \/>\n Patent system – Different types of patents – Filing process of application for patent – Infringement of patents – The patent rules 2003 as amended by the patents (amendment) rules 2016.<\/p>\n<\/p>\n<h4>Unit IV<\/h4>\n<p id=\"istudy\" style=\"text-align:center\">For the complete syllabus, results, class timetable, and many other features kindly download the <a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">iStudy App<\/a><br \/><b> It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.<\/b><br \/><a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy&pcampaignid=pcampaignidMKT-Other-global-all-co-prtnr-py-PartBadge-Mar2515-1\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/play.google.com\/intl\/en_us\/badges\/static\/images\/badges\/en_badge_web_generic.png\" alt=\"Get it on Google Play\" style=\"height:65px\"><\/a>. <\/p>\n<h4>Unit V<\/h4>\n<p align=\"justify\">\n<p><strong>Quality Audit and Self Inspections<\/strong><br \/>\n SOPs – Documentation – Loan license auditing – Common technical documentation (CTD) – Drug master file (DMF).<\/p>\n<\/p>\n<h4>Course Outcome:<\/h4>\n<p id=\"istudy\" style=\"text-align:center\">For the complete syllabus, results, class timetable, and many other features kindly download the <a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">iStudy App<\/a><br \/><b> It is a lightweight, easy to use, no images, and no pdfs platform to make students’s lives easier.<\/b><br \/><a class=\"rank-math-link\" href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy&pcampaignid=pcampaignidMKT-Other-global-all-co-prtnr-py-PartBadge-Mar2515-1\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" src=\"https:\/\/play.google.com\/intl\/en_us\/badges\/static\/images\/badges\/en_badge_web_generic.png\" alt=\"Get it on Google Play\" style=\"height:65px\"><\/a>. <\/p>\n<h4>Text Books:<\/h4>\n<p align=\"justify\">\n<ol>\n<li>C.V.SSubbrahmanyam&J.Thimmasetty, Pharmaceutical regulatory affairs, 1stEdn., vallabhPrakashan, New Delhi, 2012.<\/li>\n<li>Willig, H., Tuckeman, M.M. and Hitchings, W.S., Good Manufacturing Practices for Pharmaceuticals, 5th Edition, Marcel Dekker Drugs and the Pharmaceutical Sciences, by CRC Press, New York, 2000.<\/li>\n<li>N Udupa, Krishnamurthy Bhat, A Concise Textbook of Drug Regulatory Affairs, Manipal University Press (MUP); First Edition, 2015.<\/li>\n<\/ol>\n<h4>References:<\/h4>\n<p align=\"justify\">\n<ol>\n<li>Ira R. Berry,The Pharmaceutical Regulatory Process, marcel dekker Series: Drugs and the Pharmaceutical Sciences, by CRC Press, Newyork, 2004.<\/li>\n<li>Mindy J. Allport-Settle, Current Good Manufacturing Practices: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference, Pharmalogika Inc., USA, 2009.<\/li>\n<li>Sharma, P.P., How to Practice GMPs, 3rd Edition, Vandana Publications, 2006.<\/li>\n<\/ol>\n<p align=\"justify\">For detailed syllabus of all the other subjects of Biomedical Engineering 7th Sem, visit <a class=\"rank-math-link\" href=\"..\/category\/biomedical+7th-sem\">Biomedical 7th Sem subject syllabuses for 2019 regulation<\/a>. <\/p>\n<p align=\"justify\">For all Biomedical Engineering results, visit <a class=\"rank-math-link\" href=\"https:\/\/www.inspirenignite.com\/anna-university\/anna-university-results\/\">Anna University Biomedical all semester results<\/a> direct link. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Regulatory Requirements in Pharmaceutical Industries detailed syllabus for Biomedical Engineering (Biomedical) for 2019 regulation curriculum has been taken from the Anna Universities official website and presented for the Biomedical students. […]<\/p>\n","protected":false},"author":2297,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[67],"tags":[],"class_list":["post-32359","post","type-post","status-publish","format-standard","hentry","category-bme"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/32359","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/users\/2297"}],"replies":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/comments?post=32359"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/32359\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/media?parent=32359"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/categories?post=32359"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/tags?post=32359"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}