{"id":60943,"date":"2023-09-06T12:56:54","date_gmt":"2023-09-06T12:56:54","guid":{"rendered":"https:\/\/www.inspirenignite.com\/anna-university\/py3016-quality-management-systems-syllabus-for-pharma-2021-regulation-professional-elective-iii\/"},"modified":"2023-09-06T12:56:54","modified_gmt":"2023-09-06T12:56:54","slug":"py3016-quality-management-systems-syllabus-for-pharma-2021-regulation-professional-elective-iii","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/anna-university\/py3016-quality-management-systems-syllabus-for-pharma-2021-regulation-professional-elective-iii\/","title":{"rendered":"PY3016: Quality Management systems syllabus for Pharma 2021 regulation (Professional Elective-III)"},"content":{"rendered":"

Quality Management systems detailed syllabus for Pharmacy (Pharma) for 2021 regulation curriculum has been taken from the Anna Universities<\/a> official website and presented for the Pharma 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 Pharmacy 5th Sem scheme and its subjects, do visit Pharma 5th Sem 2021 regulation scheme<\/a>. For Professional Elective-III scheme and its subjects refer to Pharma Professional Elective-III syllabus scheme<\/a>. The detailed syllabus of quality management systems is as follows. <\/p>\n

Course Objectives:<\/h4>\n

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

Unit I<\/h4>\n

QUALITY MANAGEMENT\t9<\/strong>
\nBasics of Quality Management, Total Quality Management (TQM), Principles of Six sigma, ISO 9001 and ISO 14000, Pharmaceutical Quality Management \u2013 ICH Q10.\n<\/p>\n

Unit II<\/h4>\n

QUALITY SYSTEMS\t9<\/strong>
\nPersonal hygiene, sanitation, training, calibration, cleaning and monitoring of equipment, packaging and labeling, product coding, documentation, inventory control, ware housing.\n<\/p>\n

Unit III<\/h4>\n

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

QUALITY RISK ASSESSMENT\t9<\/strong>
\nQuality risk management – Introduction, risk assessment, risk control, risk review, risk management tools, HACCP, risk ranking and filtering according to ICH Q9 guideline.\n<\/p>\n

Unit V<\/h4>\n

QUALITY CULTURE DEVELOPMENT\t9<\/strong>
\nQuality by design \u2013 Definition, overview, elements of QbD program tools according to ICH Q8 (R2) guideline, measuring process control and quality improvement.\n<\/p>\n

Course Outcomes:<\/h4>\n
    \n
  1. Understand and develop different standards for the quality management.<\/li>\n
  2. Understand, design, develop and implement the systems in pharmaceutical industries.<\/li>\n
  3. Demonstrate and verify the process to ensure the product quality and quality systems.<\/li>\n
  4. Verify and assess the quality risk process and manage to ensure the products quality in the manufacturing.<\/li>\n
  5. Develop the quality culture by adopting new strategies for improving the process and quality of the product.<\/li>\n
  6. Understand the various standards, systems, process to ensure the quality of the product in pharmaceutical industries.<\/li>\n<\/ol>\n

    Text Books:<\/h4>\n

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

    Reference Books:<\/h4>\n
      \n
    1. cGMP Current Good Manufacturing Practices for Pharmaceuticals by Manohar A. Potdar and Ramkumar Dubey, Pharmamed Press \/ BSP Books, 2018.<\/li>\n
    2. ISO 9001, ISO 14001, and New Management Standards, by Inaki Heras-Saizarbitoria, Springer, 2018.<\/li>\n
    3. Good Manufacturing Practices for Pharmaceuticals by Graham P. Bunn, CRC Press, 2018.<\/li>\n<\/li>\n<\/ol>\n

      For detailed syllabus of all the other subjects of Pharmacy 5th Sem, visit Pharma 5th Sem subject syllabuses for 2021 regulation<\/a>. <\/p>\n

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

      Quality Management systems detailed syllabus for Pharmacy (Pharma) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the Pharma students. For course code, […]<\/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":[90],"tags":[],"class_list":["post-60943","post","type-post","status-publish","format-standard","hentry","category-pharma"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/60943","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=60943"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/60943\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/media?parent=60943"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/categories?post=60943"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/tags?post=60943"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}