M.Pharm. Pharmaceutical Quality Assurance

Campus

Kattankulathur (KTR)

Sanctioned Intake

10

Annual Fees

INR 1,50,000

Duration

2 years

About the Programme

Master of Pharmacy (M Pharm) in Pharmaceutical Quality Assurance is a 2 year postgraduate Pharmacy programme. Quality assurance is one of the most important aspects of the drug manufacturing process. It is involved in the planning, system governance and process of every phase of the pharmaceutical business to ensure that the product that gets to each patient is as safe and effective as possible. This program trains students in current good manufacturing practices (CGMP or GMP) to help ensure that goods and services meet the quality standards, efficacy and safety requirements. This means performing process validation at each step throughout the design, development, and distribution of the drug. For any issue recorded, a root cause analysis is performed and addressed quickly to keep production moving. Students will be trained in excellent manufacturing techniques as well as other pharmaceutical quality assurance practices, which will help to assure overall quality. The department also carries out numerous research activities in collaboration with various pharmaceutical industries. The curriculum and syllabi are guided as per Pharmacy Council of India (PCI), the statutory body governing pharmacy profession in the country. SRM with its well equipped laboratory setup matching industry standards, inter-disciplinary learning and research outcomes with the SRM Medicine & Health Science institutions, qualified and experienced faculty, industry oriented curriculum, placement opportunities and faculty-student mentorship program for every student offers you a distinct advantage over its peers in the field of pharmaceutical education

Eligibility for M.Pharm

1. Candidate shall have passed a Bachelor’s degree in Pharmacy from a PCI approved institution.
2. Minimum of 50% aggregate of marks in Bachelor’s Degree.
3. Students should submit Pharmacist Registration Certificate obtained from the respective state pharmacy council at the time admission.
4. Age: Minimum age limit is 21 years on or before 31st December of year of Admission.

Program Outcomes

PO1

Domain Knowledge: Possess subjective knowledge of fundamental principles and core concepts related to Pharmaceutical Quality Assurance, including points of intersection with interdisciplinary areas.

PO2

Planning abilities: Demonstrate effective planning abilities including time management, resource management, and delegation skills, Quality assurance and organisational skills. Develop and implement plans and organise work to meet deadlines.

PO3

Research Aptitude: Possess a keen interest in acquiring latest research developments in the area of Pharmaceutical Quality Assurance

PO4

Modern practices: Identify and acquire, latest industrial tools related to pharmaceutical Quality Assurance and allied science, and be able to deploy them with thorough understanding of their capabilities and limitations.

PO5

Professional Behaviour: Practice time management, resource management, organization skills and offer strategies to meet deadlines. Work in a team and participate in lifelong learning and continuous improvement in the profession

PO6

Critical thinking: Possess sufficient proficiency in problem solving skills, based on analytical thinking and research-based approaches. Shall be able to identify and assess problems and find appropriate long-term solutions to them.

PO7

Ethics: Practice and adhere to ethical principles in personal and professional life and strive to spread these virtues in the society. Respect people for their individual identity and be unbiased towards others with respect to race, cast and creed, culture, sex, physical and mental debility

PO8

Communication skills: Speak, write, read and listen clearly in person and through electronic media in English and in at least one Indian language, and relate to the world by connecting with people, ideas, books, media and technology.

PO9

Conduct investigations of complex problems: Understand and contribute to analytical principles and computational tools through different models, software’s in order to provide solutions to complex matrices in drug analysis.

PO10

Environment and sustainability: Understand the effect of materials used in pharmaceutical analysis on environment, apply domain knowledge judiciously to minimize the negative impact of hazardous chemicals on environment from the view point of pharmaceutical research. To provide better greener analytical methods in the future.

PO11

Life-long Learning: Be open minded to keep acquiring latest tools and techniques related to pharmaceutical quality assurance from various sources and contribute to the existing knowledge by adding own experiences to the body of knowledge.

Program Educational Objectives

No Education Objective
PEO1 Refining the Masters students of Pharmaceutical Quality Assurance with state-of-the-art facilities with updated knowledge and skills in analysis of drugs and pharmaceuticals.
PEO2 Train the students with critical thinking to face the challenges in any pharmaceutical company in India and abroad.
PEO3 Offer them with finest hands-on training in pharmaceutical analysis to empower the quality assurance professionals to serve in industry, academia and to become entrepreneur.
PEO4 Demonstrate competency in incorporating latest tools like quality by design, design of experiment, technology transfer, etc.
PEO5 Impart well-versed knowledge in calibration, validation and various ICH guidelines to work in pharmaceutical industry.

Program Specific Outcomes

PSO No Specific Outcomes
PSO1 Gain proficiency in regulatory procedures and their implementation within the Quality Assurance division of the pharmaceutical sector.
PSO2 Achieve innovation by contributing to the development of protocols for new product formulations and analytical methods, leveraging modern technologies and to create documentation to ensure compliance with regulatory standards.
PSO3 Develop the knowledge on Quality Management Systems (QMS) and Technology Transfer (TT) to facilitate the transfer of advanced technologies to implement quality audits to ensure the creation of safe, effective medicines for human use.

how to apply

Step 1 - register

Sign up or Register for CET with basic details (Name, Email ID, Mobile No., State, Gender and Password). Your Email ID will act as your Username for the portal while the password will be set by you upon registration.

On successful registration, you will receive the confirmation message on your registered contact number and Email. Use the Username and Password to Login to your CET Account.

syllabus

Semester - I

code

course title & Curriculum (PDF)

Hours / Week

Credits

L

T

P

C

MQA101T

Modern Pharmaceutical Analytical Techniques

-

-

-

4

MQA102T

Quality Management System

-

-

-

4

MQA103T

Quality Control and Quality Assurance

-

-

-

4

MQA104T

Product Development and Technology Transfer

-

-

-

4

MQA105P

Pharmaceutical Quality Assurance Practical - I

-

-

-

6

MPH100S

Seminar and Assignment

-

-

-

4

M.Pharm Regulations