The course curriculum has been designed to familiarise students with good manufacturing practices, ICH guidelines, calibration, validation, documentation and quality audits, with a view to create total quality consciousness. The course offers wide exposure to research fields, such as formulation development including NDDS and analytical method development, which includes validation, impurity profiling, stability indicating assay methods, preparation of documents like standard testing procedures and standard operating procedures.
The wide knowledge earned in Quality Assurance will allow the student to fit into the pharmaceutical development area.
Merits
Duration
The course shall extend over two years, consisting of two semesters in the first year, followed by research work on industry related project and submission of dissertation in the second year.
Intake
15 Seats
*Inclusive of M.Pharm+MBA-Pharmaceutical Quality Assurance program
Attendance
A student is expected to attend all classes. However, a student must put in 80% of total attendance for each subject, in the absence of which he/she will not be eligible to write the exam for that subject/submit the dissertation as the case may be. A student is required to monitor his/her own attendance and no separate notice will be displayed.
In case of genuine medical/professional/other reasons resulting in shortage of attendance, the student is encouraged to attend classes the following year as per the rules of re-registration and re-examination of NMIMS. Absence beyond 20% will not be condoned for any reason whatsoever.
Value Proposition
The department is actively engaged in following research activities:
Program Objectives
Pedagogy
The course is predominantly based on presentations and interactions with a strong focus on the research components of pharmacy. This pedagogy enables students to take decisions based on their strong academic, practical and industrial background in the pharma sector.
The course is reviewed regularly in consultation with our Board of Studies, which comprises people from pharma industry, research, FDA and pharma institutes from all over India. Thus the course is tailor made to fulfill the requirements of pharma scientists of the growing pharma industries worldwide.
Curriculum
First Year
Semester I
• Modern Pharmaceutical Analytical Techniques
• Quality Management Systems
• Quality Control and Quality Assurance
• Product Development and Technology Transfer
• Pharmaceutical Quality Assurance Practical - I
• Seminar/Assignment
• Professional Communication
Semester II
• Hazards and Safety Management
• Pharmaceutical Validation
• Audits and Regulatory Compliance
• Pharmaceutical Manufacturing Technology
• Pharmaceutical Quality Assurance Practical - II
• Seminar/Assignment
Second Year
Semester III
• Research Methodology & Biostatistics
• Journal Club
• Discussion / Presentation (Proposal Presentation)
• Research Work
Semester IV
• Journal Club
• Discussion / Final Presentation
• Research Work and Colloquium
