MASTER OF PHARMACY IN PHARMACEUTICAL QUALITY ASSURANCE
About Course:
Quality assurance in pharmacy has become a field that caters to the basic requirement of the industry that it serves, the healthcare industry. The good manufacturing practices for drugs have now become a mandate for the market to follow under the systematic, sustainable, and scientific approach adopted through the SOPs. Under such a conscious environment, it is evident that a stream like quality assurance finds its relevance, especially when the market at large is coming up with more demands in the future for perfectly trained and expert quality assurance personnel making the field a golden cradle for all the aspirants. Quality assurance is a domain that has been always offering a huge potential to the professionals to grow and succeed. To that end, we, at the Graduate School of Pharmacy, the PG School established by Gujarat Technological University, have maintained a comprehensive pattern of learning to ensure that each of our pharma students gets delivered with a perfect blend of industry-relevant knowledge and practical exposure. With our learned pool of faculties and excellent infrastructural facilities, we make sure that every student gets selected through the campus interviews with well-paid jobs in their bags.
Career in Pharmaceutical Quality Assurance
Quality Assurance does its best to maintain the reliability at every stage of the development process starting from research, clinical studies, manufacturing, laboratory testing, quality control, distribution, and marketing. Quality Assurance Department will also assist in the strategic direction and development of Quality Systems, standard operating procedures, and document control programs, to ensure adherence to the company policies and regulatory requirements. QA has the responsibility in development and implementation of Quality Systems related to good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice (GMP), and good production practices (GPP).
VISION
- To emerge as a globally recognized premier Pharmacy Institute in Teaching, Research, Innovations, Consultancy and Entrepreneurial Training in Pharmaceutical Sciences.
MISSION
- To implement modern pedagogical methods to excel in teaching, learning and research through necessary resources.
- To develop a transparent management system that facilitates staff development and encourages innovation and flexibility.
- Development of multi talent human resources by skill up-gradation of students through specialized courses and training and by facilitating international student and faculty exchange programmes.
- To engage in translational research through interdisciplinary research team and intensive symbiosis with the industries & research institutes for mutual benefits.
- To organize International & National conferences, structured workshops and outreach programmes for the benefit of students, professionals and society.
PROGRAM OUTCOMES
After successful completion of the program the graduate will be able to
- Independently carry out research /investigation and development work to solve practical problems.
- To write and present/publish a substantial technical report/document.
- To apply knowledge and concept about Quality management system utilized in the pharmaceutical organizations.
PROGRAM SPECIFIC OUTCOMES
- Develop problem-based learning approach and analytical thinking in his/her academic and professional life.
- Apply critical thinking skills, on investigation, auditing, Pharmaceutical validation, Technology transfer and safety management in Pharmaceutical industry
- Imbibe the skills of good document practice, scientific communication and research writing.
- Develop scientific approach for pharmaceutical research to provide innovative solutions.
- Create, evaluate and apply different applications of analytical techniques using various spectroscopic and chromatographic instruments.
PROGRAM EDUCATIONAL OBJECTIVES
- To demonstrate an ability to identify, investigate and solve quality issues in pharmaceutical industry.
- Execute team-based research in order to implement generic product development and technology transfer solutions in Pharmaceutical industry.
- Build independent researcher profile in all areas pertaining to Pharmaceutical Sciences.
- Be an active part of professional team and be able to lead as and when needed.
- Exercise ethical practices and moral values in personal and professional endeavors.
Note: I.S.E.A. = "Internal Assessment Sessional Exams" , E.S.E. = "End Semester Exams", * = "Non University Examination"
Semester 1
| Subject code | Subject name | No. of Hours | Credits | Marks (I.A.S.E.) | Duration | Marks(E.S.E.) | Duration(E.S.E.) | Total Marks |
| MAT101T | Modern Pharmaceutical Analytical Techniques | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
| MQA102T | Quality Management System | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
| MQA103T | Quality Control and Quality Assurance | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
| MQA104T | Product Development and Technology Transfer | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
| MQA105P | Pharmaceutical Quality Assurance Practical I | 12 | 6 | 50 | 6 hr | 100 | 6 hr | 150 |
| MSA106P | Seminar/Assignment | 8 | 4 | 100 | | | | 100 |
| Total | 36 | 26 | | | | | |
Semester 2
| Subject code | Subject name | No. of Hours | Credits | Marks (I.A.S.E.) | Duration | Marks(E.S.E.) | Duration(E.S.E.) | Total Marks |
| MQA201T | Hazards and Safety Management | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
| MQA202T | Pharmaceutical Validation | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
| MQA203T | Audits and Regulatory Compliance | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
| MQA204T | Pharmaceutical Manufacturing Technology | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
| MQA205P | Pharmaceutical Quality Assurance Practical II | 12 | 6 | 50 | 6 hr | 100 | 6 hr | 150 |
| MSA206P | Seminar/Assignment | 8 | 4 | 100 | | | | 100 |
| Total | 36 | 26 | | | | | |
Semester 3
| Subject code | Subject name | No. of Hours | Credits | Marks (I.A.S.E.) | Duration | Marks(E.S.E.) | Duration(E.S.E.) | Total Marks |
| MRM301T | Research Methodology and Biostatistics* | 4 | 4 | 20 | 1 hr | 80 | 3 hr | 100 |
| MJC302P | Journal Club I | 1 | 1 | 25 | | 0 | | 25 |
| MDP303P | Discussion/ Presentation (Proposal Presentation) | 2 | 2 | 50 | | | | 50 |
| MRW304P | Research Work - Dissertation Phase I | 28 | 14 | 50 | | 300 | | 350 |
| Total | | | | | | | 525 |
Semester 4
| Subject code | Subject name | No. of Hours | Credits | Marks (I.A.S.E.) | Duration | Marks(E.S.E.) | Duration(E.S.E.) | Total Marks |
| MJC401P | Journal Club II | 1 | 1 | 25 | | | | 25 |
| MDP402P | Discussion/ Presentation | 3 | 3 | 75 | | | | 75 |
| MRW403P | Research Work - Dissertation Phase I | 32 | 16 | 0 | | 400 | | 400 |
| Total | | | | | | | 500 |