SPS
Post Graduate
2 Years
Programme Overview
This program is designed to provide students with a basic understanding of the principles and practices of QA and QC, GMP, regulatory agencies, and documentation. The curriculum covers a wide range of topics on current industrial requirements, such as technology transfer, pharmaceutical product development & packaging, audits & regulatory compliance, industry trends & standards in light of various Quality Management Systems (QMS), etc. Students are taught to handle different QMS Quality Systems, such as OOS, CAPA, RCA, Trend analysis, etc., and to apply their understanding of quality assurance to the compilation of regulatory submissions. The program is effectively crafted to equip students for professions in many fields, encompassing formulation research, manufacturing operations, analytical research, and quality assurance in sectors like pharmaceuticals, biotech, food and nutraceuticals, cosmetics, etc. There are many options available to candidates in the Pharmaceutical Quality Assurance program to pick from to have a successful career.
Programme Objectives
- Understand quality assurance, total quality management, quality management concepts, hazard management systems, and technology transfer systems.
- Adopt GMP, Schedule M, ISO 9000 and 14000 standards, NABL accreditation, ICH, USFDA, WHO, and other regulatory guidelines and common requirements for product registration and product development.
- Dealing with different quality concepts and using modern pharmaceutical tools, software, and equipment to analyze & solve problems with the help of GLP, GCP, QbD, PAT, and their documentation
- Doing various pharmaceutical product development interactions such as calibration, validation, product complaints and recall, corrective and preventive action, documentation, and their regulatory requirement
- Dealing with various advanced instrumental techniques for the identification, characterization, and quantification of drugs and pharmaceuticals
- To generate validation protocol for all pharmaceutical operations starting from drug research to development to formulation.
Programme Outcomes
Students after completion of the course
- Understand fundamental principles and core concepts of pharmaceutical quality assurance and their connections to other disciplines from a subjective perspective.
- Exhibit effective planning skills, including time and resource management, delegation, quality assurance, and organizational abilities. Develop and execute plans and arrange tasks to meet deadlines.
- Recognize and obtain the latest industrial tools relevant to pharmaceutical quality assurance and related fields, and be capable of utilizing them while fully comprehending their capabilities and limitations.
- Develop skills in time management, and resource management organization, and provide strategies for meeting deadlines while collaborating in a team and engaging in continuous learning and professional improvement.
- Demonstrate strong problem-solving abilities through analytical thinking and research-based approaches, enabling the identification, assessment, and implementation of long-term solutions to various issues.
- Uphold ethical principles in both personal and professional life and promote these values within society, while showing respect for individual identities and maintaining impartiality towards others based on factors such as race, caste, creed, culture, gender, and physical or mental abilities.
- Contribute to the understanding and application of analytical principles and computational tools using various models and software to address complex matrices in drug analysis.
- Recognize the environmental impact of materials used in pharmaceutical analysis and responsibly apply domain knowledge to minimize the negative effects of hazardous chemicals, aiming to develop more environmentally friendly analytical methods in the future.
- Remain receptive to acquiring the latest tools and techniques related to pharmaceutical quality assurance from diverse sources and enhance existing knowledge by integrating personal experiences into the collective knowledge base.
Career Path
The topmost career opportunities after M. Pharmacy in Quality Assurance include the following:
Marketing: In the sales department of pharmaceutical companies that produce tools and machinery for research, there are ample opportunities for graduates to work in marketing and sales roles such as Medical Representatives (MR) and project managers
Clinical research:It has recently become more accessible to M.Pharm (QA), with opportunities in roles such as medical underwriters, Clinical Research Organizations (CROs), data validation associates, and clinical research associates
QA/QC Manager: Individuals with an M.Pharm (QA) degree can find employment in Quality Control and Quality Assurance departments of pharmaceutical companies, where they are responsible for ensuring the quality of manufactured drugs
Production: There is a high demand for skilled individuals in production roles within the pharmaceutical industry. While the initial pay may be lower, there is potential for rapid career growth, especially in manufacturing units where various drugs in different dosage forms and cosmetics are produced.
Scientists: Pharmaceutical graduates can pursue careers as scientists in Research & Development (R&D) and Formulation & Development (F&D). This field offers opportunities for innovation, with talented individuals in pharmacy working as scientists.
Eligibility Criteria
Minimum percentage and others criteria for admission will be as per UGC/ Concerned Regulatory Bodies.
Provided below are the criteria that need to be met for the given course.
For National Students
A Pass in the following examinations
- a) B. Pharm Degree examination of an Indian university established by law in India from an institution approved by Pharmacy Council of India and has scored not less than 55 % of the maximum marks (aggregate of 4 years of B. Pharm.)
- b) Every student, selected for admission to post graduate pharmacy program in any PCI approved institution should have obtained registration with the State Pharmacy Council or should obtain the same within one month from the date of his/her admission, failing which the admission of the candidate shall be cancelled.
- It is mandatory to submit a migration certificate obtained from the respective university where the candidate had passed his/her qualifying degree (B. Pharm.)
For International Students
- Rule framed by University Grants Commission (UGC) and notified in its website www.ugc.ac.in will be followed for deciding the eligibility and admission of International students to various courses offered in Om Sterling Global University, Hisar.
Programme Syllabus
The syllabus of the program plays a major role in how the students turn out for the profession. The syllabus drafted for the program covers all the necessary components which ensure a complete and overall education of the students. Given below is the syllabus for M. Pharmacy (Quality Assurance)
Semester I
| S.No. | Subject |
|---|---|
| 01. | Modern Pharmaceutical Analytical Techniques |
| 02. | Quality Management System |
| 03. | Quality Control and Quality Assurance |
| 04. | Product Development and Technology Transfer |
| 05. | Pharmaceutical Quality Assurance Practical- I |
| 06. | Seminar/Assignment |
Semester II
| S.No. | Subject |
|---|---|
| 01. | Hazards and Safety Management |
| 02. | Pharmaceutical Validation |
| 03. | Audits and Regulatory Compliance |
| 04. | Pharmaceutical Manufacturing Technology |
| 05. | Pharmaceutical Quality Assurance Practical- II |
| 06. | Seminar/Assignment |
Semester III
| S.No. | Subject |
|---|---|
| 01. | Research Methodology and Biostatistics* |
| 02. | Journal club |
| 03. | Discussion / Presentation (Proposal Presentation) |
| 04. | Research Work |
Semester IV
| S.No. | Subject |
|---|---|
| 01. | Journal Club |
| 02. | Research Work |
| 03. | Discussion/Final Presentation |
How to Apply
Any queries you have about the admissions and related matters, you can fill out the Admission Enquiry form; if you are unable to make a decision on deciding the program, book a free tele-counseling session with us; If you are sure about a program you are enrolling for, you can go ahead fill out the online application.
