{"id":2003,"date":"2016-08-07T11:28:33","date_gmt":"2016-08-07T11:28:33","guid":{"rendered":"http:\/\/www.inspirenignite.com\/jntuk\/?p=2003"},"modified":"2016-08-07T11:28:33","modified_gmt":"2016-08-07T11:28:33","slug":"jntuk-b-tech-quality-assurance-gmp-glp-for-r13-batch","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/jntuk\/jntuk-b-tech-quality-assurance-gmp-glp-for-r13-batch\/","title":{"rendered":"JNTUK B. Tech Quality Assurance, GMP, GLP for R13 Batch."},"content":{"rendered":"<p>JNTUK B.Tech Quality Assurance, GMP, GLP gives you detail information of Quality Assurance, GMP, GLP R13 syllabus It will be help full to understand you complete curriculum of the year.<\/p><div class=\"a9916ad81d5189659b0bfae0b37c143c\" data-index=\"1\" style=\"float: none; margin:10px 0 10px 0; text-align:center;\">\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block; text-align:center;\"\r\n     data-ad-layout=\"in-article\"\r\n     data-ad-format=\"fluid\"\r\n     data-ad-client=\"ca-pub-1181153414625576\"\r\n     data-ad-slot=\"9648548092\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\n<\/div>\n\n<p><strong>UNIT &#8211; I :<\/strong> Concept of Quality assurance, philosophy of GMP, CGMP and GLP.<\/p>\n<p><strong>LO<\/strong> : To understand Concept of Quality assurance, philosophy of GMP, CGMP and GLP.<\/p>\n<p><strong>UNIT &#8211; II<\/strong> : Organization and personnel, responsibilities, training hygiene &#8211; Premises: Location, design, plant layout, construction, maintenance and sanitations, environmental control, sterile areas, control of contamination.<\/p>\n<p><strong>LO :<\/strong> To understand organization and personnel, responsibilities, training hygiene &#8211; Premises: Location, design, plant layout, construction, maintenance and sanitations, environmental control, sterile areas, control of contamination.<\/p>\n<p><strong>UNIT &#8211; III :<\/strong> Equipments: Selection, purchase specifications, maintenance, clean in place, sterilize in place &#8211; Raw materials: Purchase specifications, maintenance of stores, selection of vendors, controls and raw materials.<\/p>\n<p><strong>LO :<\/strong> To understand selection, purchase specifications, maintenance, clean in place, sterilize in place &#8211; Raw materials: Purchase specifications, maintenance of stores, selection of vendors, controls and raw materials.<\/p>\n<p><strong>UNIT &#8211; IV :<\/strong> Manufacture and controls on dosage forms, manufacturing documents master formula, batch formula records, standard operating procedures, quality audits of manufacturing processes and facilities &#8211; In process quality control on various dosage forms: sterile, biological products and non-sterile, standard operating procedures for various operations like cleaning, filling, drying, compression, coating. Packaging and labeling controls.<\/p>\n<p><strong>LO :<\/strong> To understand manufacture and controls on dosage forms, manufacturing documents master formula, batch formula records, standard operating procedures, quality audits of manufacturing processes and facilities &#8211; In process quality control on various dosage\u00a0forms: sterile, biological products and non-sterile, standard operating procedures for various operations. Packaging and labeling controls.<\/p>\n<p><strong>UNIT &#8211; V :<\/strong> Quality Control Laboratory: Responsibilities, good laboratory practices, routine controls, instruments, protocols, non-clinical testing, controls on animal house, data generation and storage, quality control documents, retention samples, records, audits of quality control facilities &#8211; Finished products release: quality review, quality audits and batch release document.<\/p>\n<p><strong>LO :<\/strong> To understand responsibilities, good laboratory practices, routine controls, instruments, protocols, non-clinical testing, controls on animal house, data generation and storage, quality control documents, retention samples, records, audits of quality control facilities -Finished products release: quality review, quality audits and batch release document.<\/p>\n<p><strong>UNIT &#8211; VI :<\/strong> Distribution and Distribution records: Handling of returned goods, recovered materials and reprocessing Complaints and recalls, evaluation of complaints, recall procedures, related records and documents.<\/p>\n<p><strong>LO<\/strong> : To understand handling of returned goods, recovered materials and reprocessing. Complaints and recalls, evaluation of complaints, recall procedures, related records and documents.<\/p>\n<p><strong>TEXT BOOKS<\/strong><\/p>\n<ul>\n<li>The International Pharmacopoeia Vol. 1,2,3,4, 3rd edition General methods of analysis quality specifications for Pharmaceutical substances, Excipients, dosage forms.<\/li>\n<li>Quality Assurance of Pharmaceuticals: A compendium of guidelines and related material Vol. 1 and Vol. 2., WHO, (1999).<\/li>\n<li>GMP-Mehra.<\/li>\n<li>Pharmaceutical Process validation by Berry and Nash<\/li>\n<\/ul>\n<p><strong>REFERENCE BOOKS<\/strong><\/p>\n<ul>\n<li>Basic tests for Pharmaceutical substances &#8211; WHO (1988 &amp;1991)<\/li>\n<li>How to practice GMP\u2019s \u2013 P.P.Sharma<\/li>\n<li>The Drugs and Cosmetic Act 1940- Vijay Malik.<\/li>\n<li>Q.A Manual by D.H.Shah.<\/li>\n<li>SOP Guidelines by D.H.Shah.<\/li>\n<li>Quality Assurance Guide by OPPI.<\/li>\n<\/ul>\n<p>For more information about all JNTU updates please stay connected to us on FB and don\u2019t hesitate to ask any questions in the comment.<\/p>\n<div class=\"a9916ad81d5189659b0bfae0b37c143c\" data-index=\"2\" style=\"float: none; margin:10px 0 10px 0; text-align:center;\">\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block; text-align:center;\"\r\n     data-ad-layout=\"in-article\"\r\n     data-ad-format=\"fluid\"\r\n     data-ad-client=\"ca-pub-1181153414625576\"\r\n     data-ad-slot=\"8060844699\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\n<\/div>\n\n<div style=\"font-size: 0px; height: 0px; line-height: 0px; margin: 0; padding: 0; clear: both;\"><\/div>","protected":false},"excerpt":{"rendered":"<p>JNTUK B.Tech Quality Assurance, GMP, GLP gives you detail information of Quality Assurance, GMP, GLP R13 syllabus It will be help full to understand you complete curriculum of the year. [&hellip;]<\/p>\n","protected":false},"author":2259,"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":[2],"tags":[],"class_list":["post-2003","post","type-post","status-publish","format-standard","hentry","category-syllabus"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/posts\/2003","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/users\/2259"}],"replies":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/comments?post=2003"}],"version-history":[{"count":1,"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/posts\/2003\/revisions"}],"predecessor-version":[{"id":2004,"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/posts\/2003\/revisions\/2004"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/media?parent=2003"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/categories?post=2003"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/jntuk\/wp-json\/wp\/v2\/tags?post=2003"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}