{"id":3648,"date":"2020-02-07T07:06:57","date_gmt":"2020-02-07T07:06:57","guid":{"rendered":"https:\/\/www.inspirenignite.com\/up\/quality-control-regulatory-affairs-biotech-7th-sem-syllabus-for-aktu-b-tech-2019-20-scheme-departmental-elective-iii\/"},"modified":"2020-07-05T00:30:00","modified_gmt":"2020-07-05T00:30:00","slug":"quality-control-regulatory-affairs-biotech-7th-sem-syllabus-for-aktu-b-tech-2019-20-scheme-departmental-elective-iii","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/up\/quality-control-regulatory-affairs-biotech-7th-sem-syllabus-for-aktu-b-tech-2019-20-scheme-departmental-elective-iii\/","title":{"rendered":"Quality Control & Regulatory Affairs Biotech 7th Sem Syllabus for AKTU B.Tech 2019-20 Scheme (Departmental Elective-III)"},"content":{"rendered":"

Quality Control & Regulatory Affairs detail syllabus for Biotechnology (Biotech), 2019-20 scheme is taken from AKTU<\/a> official website and presented for AKTU students. The course code (RBT072), and for exam duration, Teaching Hr\/Week, Practical Hr\/Week, Total Marks, internal marks, theory marks, and credits do visit complete sem subjects post given below.<\/p>\n

For all other biotech 7th sem syllabus for b.tech 2019-20 scheme aktu you can visit Biotech 7th Sem syllabus for B.Tech 2019-20 Scheme AKTU Subjects<\/a>. For all other Departmental Elective-III subjects do refer to Departmental Elective-III<\/a>. The detail syllabus for quality control & regulatory affairs is as follows.<\/p>\n

Unit I<\/h4>\n

For the complete syllabus, results, class timetable and more kindly download iStudy<\/a>. It’s a lightweight, easy to use, no images, no pdfs platform to make student’s life easier.<\/b><\/p>\n

Unit II<\/h4>\n

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

Unit III<\/h4>\n

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

Unit IV<\/h4>\n

For the complete syllabus, results, class timetable and more kindly download iStudy<\/a>. It’s a lightweight, easy to use, no images, no pdfs platform to make student’s life easier.<\/b><\/p>\n

Unit V<\/h4>\n

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

Reference Books:<\/h4>\n
    \n
  1. Sharp J. Good Pharmaceutical Manufacturing Practice: Rationale and Compliance. CRC Press; 2005.<\/li>\n
  2. Chow SC. Encyclopedia of Biopharmaceutical Statistics. Marcel Dekker; 2003. Page 6 of 16<\/li>\n
  3. McCormick K. Quality (Pharmaceutical Engineering Series). Butterworth-Heinemann; 2002.<\/li>\n
  4. Gad SC. Pharmaceutical Manufacturing Handbook: Production and Processes. John Wiley & Sons; 2008.<\/li>\n
  5. Willig SH, Stoker JR. Good manufacturing practices for pharmaceuticals: a plan for total quality control. Marcel Dekker; 1997.<\/li>\n
  6. Signore AA, Jacobs T. Good Design Practices for GMP Pharmaceutical Facilities. Taylor &Francis Group; 2005.<\/li>\n
  7. Sarker DK. Quality Systems and Controls for Pharmaceuticals. John Wiley & Sons; 2008.<\/li>\n
  8. Haider SI. Pharmaceutical Master Validation Plan: The Ultimate Guide to FDA, GMP, and GLP Compliance. St. Lucie Press; 2002.<\/li>\n
  9. Steinborn L. GMP\/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volume 1 – With Checklists and Software Package). Taylor & Francis; 2003.<\/li>\n
  10. Kolman J, Meng P, Scott G. Good Clinical Practice: Standard Operating Procedures for Clinical Researchers. Wiley; 1998.<\/li>\n<\/ol>\n

    For detail syllabus of all other subjects of B.Tech Biotech, 2019-20 regulation do visit Biotech 7th Sem syllabus for 2019-20 Regulation<\/a>.<\/p>\n

    Don’t forget to download iStudy<\/a> for the latest syllabus, results, class timetable and more.<\/p>\n","protected":false},"excerpt":{"rendered":"

    Quality Control & Regulatory Affairs detail syllabus for Biotechnology (Biotech), 2019-20 scheme is taken from AKTU official website and presented for AKTU students. The course code (RBT072), and for exam […]<\/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-3648","post","type-post","status-publish","format-standard","hentry","category-biotechnology"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/posts\/3648","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=3648"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/posts\/3648\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/media?parent=3648"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/categories?post=3648"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/up\/wp-json\/wp\/v2\/tags?post=3648"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}