M.Pharm ( Pharmaceutical Quality Assurance)

 

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).


Note: I.S.E.A. = "Internal Assessment Sessional Exams" , E.S.E. = "End Semester Exams", * = "Non University Examination"

Subject codeSubject nameNo. of HoursCredits Marks (I.A.S.E.)DurationMarks(E.S.E.)Duration(E.S.E.)Total Marks
MAT101TModern Pharmaceutical Analytical Techniques44201 hr803 hr100
MQA102TQuality Management System44201 hr803 hr100
MQA103TQuality Control and Quality Assurance44201 hr803 hr100
MQA104TProduct Development and Technology Transfer44201 hr803 hr100
MQA105PPharmaceutical Quality Assurance Practical I126506 hr1006 hr150
MSA106PSeminar/Assignment84100100
Total3626

Subject codeSubject nameNo. of HoursCredits Marks (I.A.S.E.)DurationMarks(E.S.E.)Duration(E.S.E.)Total Marks
MQA201THazards and Safety Management44201 hr803 hr100
MQA202TPharmaceutical Validation44201 hr803 hr100
MQA203TAudits and Regulatory Compliance44201 hr803 hr100
MQA204TPharmaceutical Manufacturing Technology44201 hr803 hr100
MQA205PPharmaceutical Quality Assurance Practical II126506 hr1006 hr150
MSA206PSeminar/Assignment84100100
Total3626

Subject codeSubject nameNo. of HoursCredits Marks (I.A.S.E.)DurationMarks(E.S.E.)Duration(E.S.E.)Total Marks
MRM301TResearch Methodology and Biostatistics*44201 hr803 hr100
MJC302PJournal Club I1125025
MDP303PDiscussion/ Presentation (Proposal Presentation)225050
MRW304PResearch Work - Dissertation Phase I281450300350
Total525

Subject codeSubject nameNo. of HoursCredits Marks (I.A.S.E.)DurationMarks(E.S.E.)Duration(E.S.E.)Total Marks
MJC401PJournal Club II112525
MDP402PDiscussion/ Presentation337575
MRW403PResearch Work - Dissertation Phase I32160400400
Total500
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