The Department of Pharmaceutical Quality Assurance, established in 2002 in MCOPS, fosters research and education for undergraduate, postgraduate, and research students.? The department offers a master's program in Pharmaceutical Quality assurance with an intake of 15 students.

The department is equipped with state-of-art laboratories, ultra-modern facilities, and competent staff, which have been considered as the most sophisticated infrastructure in the country. The Department of Pharmaceutical Quality Assurance also has access to licensed e-CTD software (Take solutions) to train the postgraduate students in drug e-filing procedures. The department also offers opportunities for research students seeking Ph.D. degrees. The focused research areas of the department are

i) Drug Metabolism and Pharmacokinetic studies,

ii) Development of analytical and bioanalytical method and validation,

iii) Pharmaceutical materials science including crystal engineering and crystal structure manipulations of drug molecules

iv) Quality management system of the pharmaceutical industry

v) Expertise in preparation and submission of dossiers.

The department undertakes research projects from the government as well as private funding agencies. A number of research articles are published in reputed journals every year. The department has marked its importance in research activities and also it has an excellent placement record. Academic and research excellence is achieved by dynamic curriculum, syllabus, and pedagogy to meet the current requirements of pharmaceutical industries, academics, and regulatory bodies.

Key Features

• State-of-the-art facility.
• Diversified capabilities.
• Team of academicians with rich industry expertise and international exposure.
• Specialized and focused on analytical services.
• Patient sample analysis for therapy planning and outcome.

Core competencies

• Drug Metabolism and Pharmacokinetic studies.
• Pharmaceutical materials science including Crystal engineering and crystal structure manipulations of drug molecules.
• Stability studies of drug substances and formulations.
• Analytical and bio-analytical method development and validation.
• Quality management of the pharmaceutical industry.
• Expertise in preparation and submission of dossiers.

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PROGRAM

The program MPharm Pharmaceutical Quality Assurance has been designed to meet the needs of the ever-increasing demands of the pharmaceutical industry, research organizations, and academic institutions with special emphasis on the quality management system and regulatory submissions.

Objective:

To prepare the students to be competent, honest, industry-ready quality professionals through value-added rigorous training.

Scope:

The potential syllabus empowers students to excel and provides a lot of scope in getting the placement in reputed companies/institutes. Every year 100% placement happens through Campus recruitments for both branches. The alumni of both programs are placed in reputed pharma companies, research laboratories, and academic institutions worldwide.

• Pharmaceutical Industries: There are different areas such as quality assurance/control, technology transfer, analytical and bioanalytical method development, production/ manufacturing, validation aspects, drug metabolism and pharmacokinetics (DMPK), clinical research organizations, intellectual property rights, pharmacovigilance, scientific writing and regulatory affairs where candidates of both the disciplines are getting recruited. The scope also includes Regulatory knowledge management, which is a greenfield service domain
• Entrepreneurship and consultancy: Postgraduates are also trained and encouraged to build their career as entrepreneurs to start pharmaceutical companies or as consultants to pharma companies
• Higher studies and academics: One can also go for higher degrees in research as well as for teaching jobs in academic institutions.
  

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MPharm Pharmaceutical Quality Assurance

Course Work:
The course is designed to address the needs of the industry along with a keen emphasis on the scientific advancement of the field. It includes various aspects of Quality Assurance and related documentation, regulatory affairs, training, and analysis on advanced equipment. The course of study shall extend over a period of 4 semesters.

Program Educational Objectives (PEOs)

Program Outcomes (POs)

Course Outcomes (COs)

Click to view?Regulations for Mpharm Pharmaceutical Quality Assurance?programme

The course work for semesters includes the following subjects:

Semester I

PQA-MQA-101T: Modern Pharmaceutical Analytical Techniques
PQA-MQA102T: Quality Management Systems
PQA-MQA103T: Quality Control and Quality Assurance
PQA-MQA104T: Product Development and Technology Transfer
PQA-MQA105P: Pharmaceutical Quality Assurance Practical I
PQA-MQA106S: Seminar

Semester II

PQA-MQA201T: Hazards and Safety Management
PQA-MQA202T: Pharmaceutical Validation
PQA-MQA203T: Audits and Regulatory Compliance
PQA-MQA204T: Pharmaceutical Manufacturing Technology
PQA-MQA205P: Pharmaceutical Quality Assurance Practical II
PQA-MQA206S: Seminar

Semester III and IV

PHA-MRM301T: 中国体育彩票app下载 Methodology and Biostatistics
MRJ302P: Journal Club
MRW401P 中国体育彩票app下载 Work
In the Fourth semester MPharm, students choose a particular area of research and perform project work in a specified innovative area either in the college or in industry.

Why the Department of Pharmaceutical Quality Assurance?

The course has a well-structured, broad-based inclusive syllabus designed with inputs from experts and tailored to the present need. The students are trained in a GLP-compliant environment, ready to take up analytical, regulatory, and quality functions in any industry. The training and teaching are passionate with a firm belief that quality is not an accident, but the result of endless hard work. The Department is active in creating new knowledge by way of funded research*, high-impact research papers*, books, and industry collaborations*. 中国体育彩票app下载 of the department are spread across the globe and domain*. Most of them have reached the epitome of career and occupy key decision-making positions. They are in constant touch with the department contributing to the placements, knowledge pool, and development.

Thus 中国体育彩票app下载 College of Pharmaceutical Sciences is the dream destination for an aspiring graduate to obtain MPharm Pharmaceutical Quality Assurance.

MU has best-in-class facilities for students of all constituent institutes