{"id":61390,"date":"2023-09-06T17:18:16","date_gmt":"2023-09-06T17:18:16","guid":{"rendered":"https:\/\/www.inspirenignite.com\/anna-university\/bt3034-biotechnological-products-and-its-validation-syllabus-for-biotech-2021-regulation-professional-elective-vii\/"},"modified":"2023-09-06T17:18:16","modified_gmt":"2023-09-06T17:18:16","slug":"bt3034-biotechnological-products-and-its-validation-syllabus-for-biotech-2021-regulation-professional-elective-vii","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/anna-university\/bt3034-biotechnological-products-and-its-validation-syllabus-for-biotech-2021-regulation-professional-elective-vii\/","title":{"rendered":"BT3034: Biotechnological Products and Its Validation syllabus for BioTech 2021 regulation (Professional Elective-VII)"},"content":{"rendered":"

Biotechnological Products and Its Validation detailed syllabus for Biotechnology (BioTech) for 2021 regulation curriculum has been taken from the Anna Universities<\/a> official website and presented for the BioTech students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below. <\/p>\n

For Biotechnology 6th Sem scheme and its subjects, do visit BioTech 6th Sem 2021 regulation scheme<\/a>. For Professional Elective-VII scheme and its subjects refer to BioTech Professional Elective-VII syllabus scheme<\/a>. The detailed syllabus of biotechnological products and its validation is as follows. <\/p>\n

Unit I<\/h4>\n

Download the iStudy App for all syllabus and other updates.<\/a>
\"Get<\/a><\/h4>\n

Unit II<\/h4>\n

VALIDATION OF PHARMACEUTICAL PRODUCTION\t9<\/strong>
\nIntroduction to Pharmaceutical Validation, Scope & merits of Validation, Validation and calibration of Master plan, ICH & WHO guidelines for calibration and validation of equipm ents, Validation of specific dosage form, Types of validation. Government regulation, Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities, Analytical method validation\n<\/p>\n

Unit III<\/h4>\n

VALIDATION OF FOOD NEUTRACEUTICALS AND COSMETICS\t9<\/strong>
\nMicrobiological quality control for Nutraceuticals.\n<\/p>\n

Unit IV<\/h4>\n

Download the iStudy App for all syllabus and other updates.<\/a>
\"Get<\/a><\/h4>\n

Unit V<\/h4>\n

BIOTECHNOLOGY PROCESS AND EQUIPMENT VALIDATION\t9<\/strong>
\nProcess validation, General considerations for process equipments, Regulatory requirements for process validation, Documentation, Analytical methods.\n<\/p>\n

Text Books:<\/h4>\n
    \n
  1. Pharmaceutical Process Validation; By Fra. R. Berry and Robert A. Nash<\/li>\n
  2. Analytical Method validation and Instrument Performance Verification by Churg Chan, Heiman Lam, Y.C. Lee, Yue. Zhang, Wiley Inter Science.<\/li>\n
  3. Book: Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products, Douglas J. Ball, Daniel L. Norwood, Cheryl L. M. Stults and Lee M. Nagao,<\/li>\n
  4. Book: Medical Device 1st edition, Seeram Ramakrishna Lingling Tian Charlene Wang Susan Liao Wee Eong Teo, Woodhead Publishing, Hardcover ISBN: 9780081002896.<\/li>\n
  5. Book: Biomaterials, Medical Devices and Combination Products: Biocompatibility Testing and Safety Assessment, Shayne Cox Gad, Samanta Gad-McDonald, CRC Press<\/li>\n
  6. Fermentation Microbiology and Biotechnology by M. El-Mansi and C.Bryce<\/li>\n
  7. Process Validation: General Principles and Practices-FDA Guidelines<\/li>\n<\/li>\n<\/ol>\n

    For detailed syllabus of all the other subjects of Biotechnology 6th Sem, visit BioTech 6th Sem subject syllabuses for 2021 regulation<\/a>. <\/p>\n

    For all Biotechnology results, visit Anna University BioTech all semester results<\/a> direct link. <\/p>\n","protected":false},"excerpt":{"rendered":"

    Biotechnological Products and Its Validation detailed syllabus for Biotechnology (BioTech) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the BioTech students. For […]<\/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":[81],"tags":[],"class_list":["post-61390","post","type-post","status-publish","format-standard","hentry","category-biotech"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/61390","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=61390"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/61390\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/media?parent=61390"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/categories?post=61390"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/tags?post=61390"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}