{"id":60941,"date":"2023-09-06T12:56:49","date_gmt":"2023-09-06T12:56:49","guid":{"rendered":"https:\/\/www.inspirenignite.com\/anna-university\/py3014-audits-and-regulatory-compliance-syllabus-for-pharma-2021-regulation-professional-elective-iii\/"},"modified":"2023-09-06T12:56:49","modified_gmt":"2023-09-06T12:56:49","slug":"py3014-audits-and-regulatory-compliance-syllabus-for-pharma-2021-regulation-professional-elective-iii","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/anna-university\/py3014-audits-and-regulatory-compliance-syllabus-for-pharma-2021-regulation-professional-elective-iii\/","title":{"rendered":"PY3014: Audits and regulatory compliance syllabus for Pharma 2021 regulation (Professional Elective-III)"},"content":{"rendered":"

Audits and regulatory compliance 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 audits and regulatory compliance 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

INTRODUCTION \u2013 AUDIT\t9<\/strong>
\nObjectives, Management of audit, Responsibilities, Audit checklist for drug industries, factory acceptance test (FAT), site acceptance test.\n<\/p>\n

Unit II<\/h4>\n

VENDOR AUDIT & PRE-APPROVAL INSPECTIONS\/INVESTIGATIONS\t9<\/strong>
\nVendor certification- Objectives, vendor appraisal, Vendor rating, Assessment of new vendor, vendor preferences, rewards system. Pre-Approval Inspections- Facility cGMP compliance and the capability to produce the product, Data accuracy and completeness, Laboratory methodology, manufacturing changes to approved drugs.\n<\/p>\n

Unit III<\/h4>\n

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\"Get<\/a><\/h4>\n

Unit IV<\/h4>\n

AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT\t9
\nQuality Assurance Maintenance, Critical systems: HVAC \u2013 Purpose, life cycle, control during routine operation, Required Quality for Water for Pharmaceutical Purposes, Selection of Water for Pharmaceutical Purposes, Equipment and Components for Water System – Purposes of an Air Handling System, verification of air quality Cleanliness.\n<\/p>\n

Unit V<\/h4>\n

QUALITY AUDIT AND REGULATORY COMPLIANCE\t9<\/strong>
\nScope, objective, quality audit, periodic evaluation, self-inspection, quality audit \u2013 internal audit, external audit, regulatory audit, role of GMP audits in QC and QA, benefits of GMP audits, elements of a systemic audit.\n<\/p>\n

Course Outcomes:<\/h4>\n
    \n
  1. Perform the auditing in pharmaceutical industries.<\/li>\n
  2. Design and develop the check list for vendor auditing and inspection of the pharmaceutical industries.<\/li>\n
  3. Design and develop process in checking the microbial laboratory facility.<\/li>\n
  4. Perform and verify the critical engineering systems in pharmaceutical manufacturing area.<\/li>\n
  5. Demonstrate the different auditing process and prepare the compliance report for approval pharmaceutical products.<\/li>\n
  6. Understand the various auditing and inspection process to ensure the quality of the pharmaceutical product.<\/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. Laboratory auditing for quality and regulatory compliance. Donald C. Singer, Raluca-loana Stefan, Jacobus F. Van Staden. CRC Press (2008).<\/li>\n
    2. Pharmaceutical Process validation by Robert A. Nash, Alfred H. Wachter, Marcel Dekker Inc, 2003.<\/li>\n
    3. Pharmaceutical Vendors Approval Manual A Comprehensive Quality Manual for API and Packaging Material Approval by Erfan Syed Asif, CRC Press, 2021.<\/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":"

      Audits and regulatory compliance 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 […]<\/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-60941","post","type-post","status-publish","format-standard","hentry","category-pharma"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/60941","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=60941"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/60941\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/media?parent=60941"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/categories?post=60941"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/tags?post=60941"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}