{"id":8873,"date":"2019-12-15T04:53:09","date_gmt":"2019-12-15T04:53:09","guid":{"rendered":"https:\/\/www.inspirenignite.com\/vtu\/good-manufacturing-practices-syllabus-for-vtu-be-2017-scheme-open-elective-2\/"},"modified":"2019-12-15T04:53:09","modified_gmt":"2019-12-15T04:53:09","slug":"good-manufacturing-practices-syllabus-for-vtu-be-2017-scheme-open-elective-2","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/vtu\/good-manufacturing-practices-syllabus-for-vtu-be-2017-scheme-open-elective-2\/","title":{"rendered":"Good Manufacturing Practices Syllabus for VTU BE 2017 Scheme (Open Elective-2)"},"content":{"rendered":"<p>Good Manufacturing Practices detail syllabus for various departments, 2017 scheme is taken from <a href=\"https:\/\/vtu.ac.in\/b-e-scheme-syllabus\/\" target=\"_blank\" rel=\"noopener\">VTU<\/a> official website and presented for VTU students. The course code (17BT663), and for exam duration, Teaching Hr\/week, Practical Hr\/week, Total Marks, internal marks, theory marks, duration and credits do visit complete sem subjects post given below.<\/p>\n<p>For all other open elective-2 syllabus for vtu be 2017 scheme you can visit <a href=\"..\/open-elective-2-syllabus-for-vtu-be-2017-scheme\">Open Elective-2 syllabus for VTU BE 2017 Scheme Subjects<\/a>. The detail syllabus for good manufacturing practices is as follows.<\/p>\n<p><h4>Course Objectives:<\/h4>\n<p> This course will enable students to understand the aspects of good manufacturing practices from its regulatory and application perspective.\n<\/p>\n<p><h4>Module 1<br \/>\nFor complete syllabus and results, class timetable and more pls <a href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">download iStudy<\/a>. Its a light weight, easy to use, no images, no pdfs platform to make students life easier.<\/p>\n<p><h4>Module 2<br \/>\n<\/h4>\n<p>CONCEPTS OF QUALIFICATION AND VALIDATION: Concepts of equipment qualification &#8211; Concepts of Validation and importance of the same -Method &amp; Process development and validation &#8211; Validation Master Plan (VMP).\n<\/p>\n<p><h4>Module 3<br \/>\n<\/h4>\n<p>GOOD DOCUMENTATION PRACTICES: Importance and need for GDP &#8211; Standard Operating Procedures (SOP) and Standard Testing Procedures (STP) &#8211; Raw Data Sheet (RDS) to Reports &#8211; Batch Manufacturing Record &#8211; Electronic records regulation &#8211; 21 CFR Part 11\n<\/p>\n<p><h4>Module 4<br \/>\nFor complete syllabus and results, class timetable and more pls <a href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">download iStudy<\/a>. Its a light weight, easy to use, no images, no pdfs platform to make students life easier.<\/p>\n<p><h4>Module 5<br \/>\n<\/h4>\n<p>ADVANCES IN GMP: Parametric release of products &#8211; Quality Risk Management System &#8211; Process Analytical Technologies &#8211; Quality by Design.\n<\/p>\n<p><h4>Course Outcomes:<\/h4>\n<p> After studying this course, students will be able to:<\/p>\n<ul>\n<li>Learn and adopt quickly in a GMP environment.<\/li>\n<li>Understand the principles and applications of the GMP.<\/li>\n<\/ul>\n<p><h4>Reference Books:<\/h4>\n<ol>\n<li>U.S. Department of Health and Human Services Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, 2016.<\/li>\n<li>U.S. Department of Health and Human Services Sterile Drug Products Produced by  Aseptic Processing Current Good Manufacturing Practice 2004<\/li>\n<\/ol>\n<p><h4>Text Books:<\/h4>\n<ol>\n<li>Syed Imtiaz Haider., Pharmaceutical Master Validation Plan The Ultimate Guide to FDA, GMP, and GLP Compliance, ST. LUCIE PRESS 2002.<\/li>\n<li>WHO Good manufacturing practices and inspection 2004.<\/li>\n<li>John Sharp ., Good Pharmaceutical Manufacturing Practice Rationale and Compliance 2005<\/li>\n<\/li>\n<\/ol>\n<p>For detail syllabus of all other subjects of BE do syllabus for different schemes from menu given on top.<\/p>\n<p>Dont forget to <a href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">download iStudy<\/a> for latest syllabus and results, class timetable and more.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Good Manufacturing Practices detail syllabus for various departments, 2017 scheme is taken from VTU official website and presented for VTU students. The course code (17BT663), and for exam duration, Teaching [&hellip;]<\/p>\n","protected":false},"author":2298,"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":[15],"tags":[],"class_list":["post-8873","post","type-post","status-publish","format-standard","hentry","category-syllabus"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/vtu\/wp-json\/wp\/v2\/posts\/8873","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inspirenignite.com\/vtu\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.inspirenignite.com\/vtu\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/vtu\/wp-json\/wp\/v2\/users\/2298"}],"replies":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/vtu\/wp-json\/wp\/v2\/comments?post=8873"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/vtu\/wp-json\/wp\/v2\/posts\/8873\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/vtu\/wp-json\/wp\/v2\/media?parent=8873"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/vtu\/wp-json\/wp\/v2\/categories?post=8873"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/vtu\/wp-json\/wp\/v2\/tags?post=8873"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}