PY3016: Quality Management systems syllabus for Pharma 2021 regulation (Professional Elective-III)

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, 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 quality management systems is as follows.

Course Objectives:

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Unit I

Basics of Quality Management, Total Quality Management (TQM), Principles of Six sigma, ISO 9001 and ISO 14000, Pharmaceutical Quality Management – ICH Q10.

Unit II

Personal hygiene, sanitation, training, calibration, cleaning and monitoring of equipment, packaging and labeling, product coding, documentation, inventory control, ware housing.

Unit III

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Unit IV

Quality risk management – Introduction, risk assessment, risk control, risk review, risk management tools, HACCP, risk ranking and filtering according to ICH Q9 guideline.

Unit V

Quality by design – Definition, overview, elements of QbD program tools according to ICH Q8 (R2) guideline, measuring process control and quality improvement.

Course Outcomes:

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

Text Books:

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Reference Books:

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

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.

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