{"id":21110,"date":"2019-12-10T07:22:06","date_gmt":"2019-12-10T07:22:06","guid":{"rendered":"https:\/\/www.inspirenignite.com\/anna-university\/validation-in-pharmaceutical-industries-pharma-6th-sem-syllabus-for-b-tech-2017-regulation-anna-univ-professional-elective-ii\/"},"modified":"2019-12-10T07:22:06","modified_gmt":"2019-12-10T07:22:06","slug":"validation-in-pharmaceutical-industries-pharma-6th-sem-syllabus-for-b-tech-2017-regulation-anna-univ-professional-elective-ii","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/anna-university\/validation-in-pharmaceutical-industries-pharma-6th-sem-syllabus-for-b-tech-2017-regulation-anna-univ-professional-elective-ii\/","title":{"rendered":"Validation in Pharmaceutical Industries Pharma 6th Sem Syllabus for B.Tech 2017 Regulation Anna Univ (Professional Elective II)"},"content":{"rendered":"<p>Validation in Pharmaceutical Industries Pharma 6th Sem Syllabus for B.Tech 2017 Regulation Anna Univ (Professional Elective II) detail syllabus for Pharmacy (Pharma), 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 (PY8005), Category (PE), 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 pharma 6th sem syllabus for b.tech 2017 regulation anna univ you can visit <a href=\"..\/pharma-6th-sem-syllabus-for-b-tech-2017-regulation-anna-univ\">Pharma 6th Sem syllabus for B.Tech 2017 regulation Anna Univ Subjects<\/a>. For all other Professional Elective II subjects do refer to <a href=\"..\/professional-elective-ii-pharma-6th-sem-syllabus-for-b-tech-2017-regulation-anna-univ\">Professional Elective II<\/a>. The detail syllabus for validation in pharmaceutical industries is as follows.<\/p>\n<p><h4>Course Objective:<\/h4>\n<ul>\n<li>To provide the information on GMP\/GLP regulation involved in the manufacturing OfAPI and biological products.<\/li>\n<li>To provide the importance of impurity profile and stability testing of drugs.<\/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><strong>Impurities in Drug Substances and Drug Products<\/strong><br \/>\nDefinition of impurities-Validation and impurity issue related to manufacturing -Processing of drug substances -Enantiomers as impurities -Polymorphs as unwanted components.\n<\/p>\n<p><h4>Unit III<\/h4>\n<p><strong>Cleaning Procedure Inapimanufacturingfacilities<\/strong><br \/>\nRegulatory requirements-Multiple vs dedicated equipment- Unique nature of API-Multiple level approach to cleaning-Nature of contaminants-Selection of a worst case-Cleaning techniques -Sampling &#8211; Analytical methods &#8211; Limits and acceptance criteria, documentation.\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><strong>Process Validation<\/strong><br \/>\nProcess validation as a quality assurance tool-General QA tools, purpose of process validation, Qualification activities, Process validation activities. Prospective process validation-Organization, documentation, product development, development of manufacturing capability, full scale production development, defining experimental programs, experimental design and analysis.\n<\/p>\n<p><h4>Course Outcome:<\/h4>\n<p>The students will be able to<\/p>\n<ul>\n<li>Understand regulatory practices and administrative functions adopted in the Pharmaceutical organizations.<\/li>\n<li>Understand the importance of impurity and the procedure for determination of expiry date.<\/li>\n<li>Understand the role of cleanliness in manufacturing high purity products and reducing adverse products<\/li>\n<\/ul>\n<p><h4>Text Books:<\/h4>\n<ol>\n<li>R.A. Nash, A.H. Wachter, Pharmaceutical Process Validation, 3rd ed., CRC Press, Taylor and Francis Group, 2003.<\/li>\n<li>Y. Anjaneyulu,R.Maraya, Quality Assurance and Quality Management in PharmaceuticalIndustry,PharmaBookSyndicate,2005.<\/li>\n<li>J. P. Agalloco,F.J. Carleton, Validation of Pharmaceutical Processes, 3rd ed., Informa Healthcare, NY, USA, 2007.<\/li>\n<\/ol>\n<p><h4>References:<\/h4>\n<ol>\n<li>Willig,S.H., Good Manufacturing Practice for Pharmaceuticals,\t5th Edition, MarcelDekker,2005.<\/li>\n<li>A.A. Signore, T. Jacobs, Good Design Practices for GMP Pharmaceutical Facilities 1st ed., CBS Publishers and Distributors Pvt. Ltd., 2009.<\/li>\n<li>S.C. Chow, Statistical Design and Analysis of Stability Studies Chapman and Hall\/CRC, 2007.<\/li>\n<\/li>\n<\/ol>\n<p>For detail syllabus of all other subjects of B.Tech Pharma, 2017 regulation do visit <a href=\"..\/category\/pharma+6th-sem\">Pharma 6th 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>Validation in Pharmaceutical Industries Pharma 6th Sem Syllabus for B.Tech 2017 Regulation Anna Univ (Professional Elective II) detail syllabus for Pharmacy (Pharma), 2017 regulation is collected from the Anna Univ [&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":[49,90],"tags":[],"class_list":["post-21110","post","type-post","status-publish","format-standard","hentry","category-6th-sem","category-pharma"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/21110","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=21110"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/21110\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/media?parent=21110"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/categories?post=21110"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/tags?post=21110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}