{"id":18450,"date":"2019-12-10T05:38:35","date_gmt":"2019-12-10T05:38:35","guid":{"rendered":"https:\/\/www.inspirenignite.com\/anna-university\/regulatory-requirements-in-pharmaceutical-industries-bme-7th-sem-syllabus-for-be-2017-regulation-anna-univ-open-elective-ii\/"},"modified":"2019-12-10T05:38:35","modified_gmt":"2019-12-10T05:38:35","slug":"regulatory-requirements-in-pharmaceutical-industries-bme-7th-sem-syllabus-for-be-2017-regulation-anna-univ-open-elective-ii","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/anna-university\/regulatory-requirements-in-pharmaceutical-industries-bme-7th-sem-syllabus-for-be-2017-regulation-anna-univ-open-elective-ii\/","title":{"rendered":"Regulatory Requirements in Pharmaceutical Industries Bme 7th Sem Syllabus for BE 2017 Regulation Anna Univ (Open Elective II)"},"content":{"rendered":"<p>Regulatory Requirements in Pharmaceutical Industries Bme 7th Sem Syllabus for BE 2017 Regulation Anna Univ (Open Elective II) detail syllabus for Biomedical Engineering (Bme), 2017 regulation is collected from the <a href=\"https:\/\/www.annauniv.edu\/\" target=\"_blank\" rel=\"noopener\">Anna Univ<\/a> official website and presented for students of Anna University. The details of the course are: course code (OPY752), Category (OE), Contact Periods\/week (3), Teaching hours\/week (3), Practical Hours\/week (0). The total course credits are given in combined syllabus.<\/p>\n<p>For all other bme 7th sem syllabus for be 2017 regulation anna univ you can visit <a href=\"..\/bme-7th-sem-syllabus-for-be-2017-regulation-anna-univ\">Bme 7th Sem syllabus for BE 2017 regulation Anna Univ Subjects<\/a>. For all other Open Elective II subjects do refer to <a href=\"..\/open-elective-ii-bme-7th-sem-syllabus-for-be-2017-regulation-anna-univ\">Open Elective II<\/a>. The detail syllabus for regulatory requirements in pharmaceutical industries is as follows.<\/p>\n<p><h4>Course Objective:<\/h4>\n<ul>\n<li>To acquire the knowledge of pharmaceutical industry regulations and research<\/li>\n<\/ul>\n<p><h4>Unit I<\/h4>\n<p>For 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>Unit II<\/h4>\n<\/p>\n<p><strong> Regulatory Aspects<\/strong><Br><br \/>\nPharmaceuticals: Bulk drug manufacture; Personnel, Buildings and Facilities, Process Equipment, Documentation and Records, Materials Management, Production and In-Process Controls, Packaging and Identification Labelling of APIs and Intermediates, Storage and distribution, &#8211; Biotechnology derived products; Principles, Personnel, Premises and equipments, Animal quarters and care, production, labelling, Lot processing records and distribution records, quality assurance and quality control.\n<\/p>\n<p><h4>Unit III<\/h4>\n<\/p>\n<p><strong> Intellectual Property Rights<\/strong><Br><br \/>\nPatent system &#8211; Different types of patents &#8211; Filing process of application for patent &#8211; Infringement of patents &#8211; The patent rules 2003 as amended by the patents (amendment) rules 2016.\n<\/p>\n<p><h4>Unit IV<\/h4>\n<p>For 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>Unit V<\/h4>\n<\/p>\n<p><strong> Quality Audit and Self Inspections<\/strong><Br><br \/>\nSOPs &#8211; Documentation &#8211; Loan license auditing &#8211; Common technical documentation (CTD) &#8211; Drug master file (DMF).\n<\/p>\n<p><h4>Course Outcome:<\/h4>\n<p>On completion of the course, the student will be able<\/p>\n<ul>\n<li>To be familiarise with the pharmaceutical industry manufacturing practices and regulatory aspects of pharmacy products.<\/li>\n<li>To know the process of patenting activities.<\/li>\n<li>To know the quality guidelines followed for pharmaceutical products and few of the aspects involved in document preparation for pharmaceutical product registration.<\/li>\n<\/ul>\n<p><h4>Text Books:<\/h4>\n<ol>\n<li>C.V.SSubbrahmanyam&amp;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<p><h4>References:<\/h4>\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<\/li>\n<\/ol>\n<p>For detail syllabus of all other subjects of BE Bme, 2017 regulation do visit <a href=\"..\/category\/bme+7th-sem\">Bme 7th Sem syllabus for 2017 Regulation<\/a>.<\/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>Regulatory Requirements in Pharmaceutical Industries Bme 7th Sem Syllabus for BE 2017 Regulation Anna Univ (Open Elective II) detail syllabus for Biomedical Engineering (Bme), 2017 regulation is collected from the [&hellip;]<\/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":[50,67],"tags":[],"class_list":["post-18450","post","type-post","status-publish","format-standard","hentry","category-7th-sem","category-bme"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/18450","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=18450"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/18450\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/media?parent=18450"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/categories?post=18450"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/tags?post=18450"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}