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 code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Pharmacy 5th Sem scheme and its subjects, do visit Pharma 5th Sem 2021 regulation scheme. For Professional Elective-III scheme and its subjects refer to Pharma Professional Elective-III syllabus scheme. The detailed syllabus of audits and regulatory compliance is as follows.
Course Objectives:
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Unit I
INTRODUCTION – AUDIT 9
Objectives, Management of audit, Responsibilities, Audit checklist for drug industries, factory acceptance test (FAT), site acceptance test.
Unit II
VENDOR AUDIT & PRE-APPROVAL INSPECTIONS/INVESTIGATIONS 9
Vendor 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.
Unit III
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Unit IV
AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT 9
Quality Assurance Maintenance, Critical systems: HVAC – 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.
Unit V
QUALITY AUDIT AND REGULATORY COMPLIANCE 9
Scope, objective, quality audit, periodic evaluation, self-inspection, quality audit – internal audit, external audit, regulatory audit, role of GMP audits in QC and QA, benefits of GMP audits, elements of a systemic audit.
Course Outcomes:
- Perform the auditing in pharmaceutical industries.
- Design and develop the check list for vendor auditing and inspection of the pharmaceutical industries.
- Design and develop process in checking the microbial laboratory facility.
- Perform and verify the critical engineering systems in pharmaceutical manufacturing area.
- Demonstrate the different auditing process and prepare the compliance report for approval pharmaceutical products.
- Understand the various auditing and inspection process to ensure the quality of the pharmaceutical product.
Text Books:
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Reference Books:
- Laboratory auditing for quality and regulatory compliance. Donald C. Singer, Raluca-loana Stefan, Jacobus F. Van Staden. CRC Press (2008).
- Pharmaceutical Process validation by Robert A. Nash, Alfred H. Wachter, Marcel Dekker Inc, 2003.
- Pharmaceutical Vendors Approval Manual A Comprehensive Quality Manual for API and Packaging Material Approval by Erfan Syed Asif, CRC Press, 2021.
For detailed syllabus of all the other subjects of Pharmacy 5th Sem, visit Pharma 5th Sem subject syllabuses for 2021 regulation.
For all Pharmacy results, visit Anna University Pharma all semester results direct link.