{"id":17797,"date":"2021-11-23T07:36:27","date_gmt":"2021-11-23T07:36:27","guid":{"rendered":"https:\/\/www.inspirenignite.com\/up\/departmental-elective-5-kbt076-quality-control-and-regulatory-affairs-biotechnology-7th-sem-syllabus-for-aktu-b-tech-2021-22-scheme\/"},"modified":"2021-11-23T07:36:27","modified_gmt":"2021-11-23T07:36:27","slug":"departmental-elective-5-kbt076-quality-control-and-regulatory-affairs-biotechnology-7th-sem-syllabus-for-aktu-b-tech-2021-22-scheme","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/up\/departmental-elective-5-kbt076-quality-control-and-regulatory-affairs-biotechnology-7th-sem-syllabus-for-aktu-b-tech-2021-22-scheme\/","title":{"rendered":"(Departmental Elective-5) KBT076: Quality Control and Regulatory affairs Biotechnology 7th Sem Syllabus for AKTU B.Tech 2021-22 Scheme"},"content":{"rendered":"

Quality Control and Regulatory affairs detail syllabus for Biotechnology (Biotechnology), 2021-22 scheme is taken from AKTUs<\/a> official website and presented for the AKTU B.Tech students. For the course code (KBT076), exam duration, teaching hr\/week, practical hr\/week, total marks, internal marks, theory marks, duration, credits, and other details do visit complete semester subjects post given below.<\/p>\n

For the Biotechnology 7th Sem Syllabus for AKTU B.Tech 2021-22 Scheme you can visit Biotechnology 7th Sem 2021-22 Scheme<\/a>. For the Departmental Elective-5 scheme of Biotechnology 7th Sem 2021-22 regulation do refer to Departmental Elective-5 Biotechnology 7th Sem scheme<\/a>. The detail syllabus for quality control and regulatory affairs is as follows.<\/p>\n

Quality Control and Regulatory affairs<\/title><\/p>\n<h4>PreRequisites:<\/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\" rel=\"nofollow noopener\" target=\"_blank\">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\" rel=\"nofollow noopener\" target=\"_blank\"><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>Course Objectives:<\/h4>\n<ul>\n<li>This course is designed with an objective to provide an understanding of the knowledge of Quality control and Quality management<\/li>\n<li>To learn the concepts of GMP,GLP, standard test procedure and CPCSEA guidelines in Biological samples<\/li>\n<li>To provide the knowledge of Quality review and batch release document, audits of quality control etc.<\/li>\n<li>To develop understanding of Good documentation processes, clinical studies guidelines, IP generation pharmacovigilance and product registration guidelines etc.<\/li>\n<\/ul>\n<h4>Course Outcomes:<\/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\" rel=\"nofollow noopener\" target=\"_blank\">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\" rel=\"nofollow noopener\" target=\"_blank\"><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>Reference Books:<\/h4>\n<ol>\n<li>Sharp J. Good Pharmaceutical Manufacturing Practice: Rationale and Compliance. CRC Press 2005<\/li>\n<li>Haider SI. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, andGLP Compliance. St. Lucie Press 2002<\/li>\n<li>Swarbrick J. Encyclopedia of Pharmaceutical Technology. Informa Healthcare 2007<\/li>\n<li>Kolman J, Meng P, Scott G. Good Clinical Practice: Standard Operating Procedures forClinical Researchers. Wiley 1998<\/li>\n<li>Signore AA, Jacobs T. Good Design Practices for GMP Pharmaceutical Facilities. Taylor&Francis Group 2005<\/li>\n<\/ol>\n<h4>Unit I<\/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\" rel=\"nofollow noopener\" target=\"_blank\">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\" rel=\"nofollow noopener\" target=\"_blank\"><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 II<\/h4>\n<p> Quality review and batch release document of finished products, annual product quality review and parametric release, Audits, quality audits of manufacturing processes and facilities, audits of quality control.<\/p>\n<h4>Unit III<\/h4>\n<p> Good documentation practices, route cause analysis, corrective action preventive action (CAPA), out of specifications (OOS) and out of trend (OOT), Clinical studies- ICH GCP (E6) guidelines, post marketing surveillance, Pharmacovigilance<\/p>\n<h4>Unit IV<\/h4>\n<p> BABE (bioavailability and bioequivalence) studies, Concepts and management of contract manufacturing guidelines, Statistical Tools for Quality Control and Precision, Tools of Problem Solving and Continuous Improvement.<\/p>\n<h4>Unit V<\/h4>\n<p> Introduction, scope and importance of IPR, Concept of trade mark, copyright and patents Product registration guidelines – CDSCO, USFDA, Concept of ISO (9001):(2008), (14000), OSHAS guidelines, Quality Strategy for Indian Industry, Brief concept of IND, NDA, ANDA, SNDA and PAT.<\/p>\n<p align=\"justify\">For the syllabus of all the subjects of B.Tech Biotechnology 7th Sem, 2021-22 scheme do visit <a class=\"rank-math-link\" href=\"..\/category\/biotechnology+7th-sem\">Biotechnology 7th Sem syllabus subjects<\/a>.<\/p>\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\" rel=\"nofollow noopener\" target=\"_blank\">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\" rel=\"nofollow noopener\" target=\"_blank\"><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","protected":false},"excerpt":{"rendered":"<p>Quality Control and Regulatory affairs detail syllabus for Biotechnology (Biotechnology), 2021-22 scheme is taken from AKTUs official website and presented for the AKTU B.Tech students. For the course code (KBT076), […]<\/p>\n","protected":false},"author":2300,"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":[45],"tags":[],"class_list":["post-17797","post","type-post","status-publish","format-standard","hentry","category-biotechnology"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/posts\/17797","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/users\/2300"}],"replies":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/comments?post=17797"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/posts\/17797\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/media?parent=17797"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/categories?post=17797"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/tags?post=17797"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}