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Overview

The Department of Pharmaceutical Quality Assurance, established in 2002 in MCOPS, has two MPharm specializations viz., Pharmaceutical Quality Assurance and Pharmaceutical Regulatory Affairs, each having intake of 15 students. The department is equipped with the state-of-art laboratories, ultra-modern facilities and competitive staff, which have been considered as most sophisticated infrastructure in the country. The Department of Pharmaceutical Quality Assurance is the only department among academic institution in the country to have licenced e-CTD software (Take solutions) to train the postgraduate students in drug e-filing procedures. The department also offers opportunities for research students seeking PhD degree. The focused research areas of the department are i) Drug Metabolism and Pharmacokinetic studies, ii) Development of analytical and bio-analytical method and validation, iii) Pharmaceutical materials science including crystal engineering and crystal structure manipulations of drug molecules iv) Quality management system of pharmaceutical industry v) Expertise in preparation and submission of dossiers.

The department undertakes research projects from 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 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 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.

 

 PROGRAMS

The programs MPharm Pharmaceutical Quality Assurance and MPharm Pharmaceutical Regulatory Affairs 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 the 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 bio-analytical 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 green field service domain
  • Entrepreneurship and consultancy: Post graduates are also trained and encouraged to build their career as entrepreneurs to start pharmaceutical company 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.

 

MPharm Pharmaceutical Quality Assurance

Course Work:
The course is designed to address the needs of industry along with a keen emphasis on 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. The course work for semesters includes 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: Research Methodology and Biostatistics
MRJ302P: Journal Club
MRW401P Research Work
In Fourth semester MPharm, students choose a particular area of research and perform a project work in a specified innovative area either in the college or in industry.

MPharm Pharmaceutical Regulatory Affairs

Course Work:

The course provides a comprehensive understanding of important aspects of Regulatory and Quality Compliance in the pharmaceutical industry. Course focuses on imparting fundamental knowledge on various Good Regulatory Practices, documentation and regulatory writing, which involves dossier preparation and submission as per the industry trends. The course of study shall extend over a period of 4 semesters. The course work for semesters includes following subjects:

Semester I

PQA-MRA101T: Good Regulatory Practices
PQA-MRA102T: Documentation and Regulatory Writing
PQA-MRA103T: Clinical Research Regulations
PQA-MRA104T: Regulations and Legislation for Drugs & Cosmetics, Medical Devices, Biologicals & Herbals
and Food & Nutraceuticals in India and Intellectual Property Rights
PQA-MRA105P: Regulatory Affairs Practical I
PQA-MRA106S: Seminar

Semester II

PQA-MRA201T: Regulatory Aspects of Drugs and Cosmetics
PQA-MRA202T: Regulatory Aspects of Herbal and Biologicals
PQA-MRA203T: Regulatory Aspects of Medical Devices
PQA-MRA204T: Regulatory Aspects of Food and Nutraceuticals
PQA-MRA205P: Regulatory Affairs Practical II
PQA-MRA206S: Seminar

Semester III and IV

PHA-MRM301T: Research Methodology and Biostatistics
MRJ302P: Journal Club
MRW401P Research Work

In Fourth semester MPharm, students choose a particular area of research and perform a 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*. Alumni 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 Manipal College of Pharmaceutical Sciences is the dream destination for an aspiring graduate to obtain MPharm Pharmaceutical Quality Assurance and Pharmaceutical Regulatory Affairs.

Opportunities
Academics

Department offers postgraduate courses in Pharmaceutical Quality Assurance and Pharmaceutical Regulatory Affairs.

Research

Department provides research opportunities in the field of analytical and regulatory science through its doctoral program.

DADC

As a part of MCOPS Drug Analysis and Development Centre (DADC), department extends sample analysis services.

Faculty

Labs & Facilities

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

Licensed e-CTD Software

The Department has licenced e-CTD software (Take solutions) to train the students in regulatory e-filing procedures.

Research & Publications

The department established in the year 2002 under the leadership of Dr. G. Gautham Shenoy. Since then the department has grown on its identity and reach on research. It has received grants worth few crores from various funding agencies like AICTE, DST, etc. with the liberal financial support from the university and grants from the governmental agencies, the department could establish and maintain a “state-of-the-art” sophisticated instrumentation laboratory. This is serving as a nodal analytical research Centre not only for the researchers of Pharmacy College but the whole Manipal Academy of Higher Education and neighbouring academic institutions. A large number of high impact publications have been generated by the researchers of the department using the facility. Off late, the department is active in collaborative research with various constituent institutions of the university. This collaboration has resulted in many other grants from the funding agencies like with the Department of Biochemistry from VGST, Department of Gastroenterology from DST, and Department of Medicine from ICMR, etc. The Department is also an analytical service provider and consultant for many pharmaceutical industries like Steer Engineering, Get well pharma, etc. The department also helps many students from neighbouring academic institutions like NITTE University, Yenepoya University, and SDM &Muniyal Institute of Ayurveda Medical Sciences, various pharmacy colleges across the state of Karnataka and beyond in fructifying their research efforts. Staff members of the department act as a consultant, evaluators, book authors, journal referees, editors, etc, because of their competency and contribution in the core knowledge domain.

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