The M. Pharm (Pharmaceutical Quality Assurance) program at Vishwakarma University is meticulously crafted to equip students with an in-depth understanding and mastery of the critical principles and practices associated with quality assurance within the pharmaceutical industry. This comprehensive program spans a wide array of topics that ensure students are well-prepared to meet the evolving demands of this dynamic field.
The curriculum covers essential aspects such as regulatory requirements and the stringent standards set by international and national authorities like the FDA, EMA, and CDSCO. This includes a thorough exploration of guidelines, frameworks, and protocols that govern the pharmaceutical industry, emphasizing the importance of compliance in delivering safe and effective products.
A significant component of the program is devoted to quality control, where students will delve into the techniques and methods required to maintain the integrity of pharmaceutical products. They will become proficient in both chemical and microbiological testing procedures, ensuring products adhere to predefined quality parameters.
In addition, the course covers process validation, enabling students to understand and implement validation processes that guarantee consistent product quality. This includes an understanding of critical manufacturing parameters, validation strategies, and the optimization of processes to meet regulatory standards.
The program also emphasizes the importance of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Through GLP, students will gain expertise in the ethical, technical, and managerial aspects of laboratory practices, ensuring that testing and research are performed with high-quality standards. The GMP training, on the other hand, will prepare students to ensure that pharmaceutical products are consistently produced and controlled according to quality standards, safeguarding the safety of end consumers.
The course instills a holistic understanding of the entire product lifecycle, from drug development to commercialization, with an emphasis on maintaining safety, efficacy, and quality at each stage. Students will develop the analytical skills required for identifying, assessing, and mitigating potential risks associated with pharmaceutical production.
The M. Pharm (Pharmaceutical Quality Assurance) program also emphasizes the development of managerial and leadership skills. Students will learn to oversee quality assurance teams, manage regulatory inspections, and ensure organizational compliance with global regulatory standards. The technical, analytical, and managerial expertise gained through this program will prepare graduates to ensure that pharmaceutical products not only meet but exceed the rigorous standards of the industry.
This program offers students a comprehensive, multifaceted education that prepares them to excel in the pharmaceutical industry by upholding the highest standards of product safety, efficacy, and quality.
Outcome | On successful completion of M. Pharmacy in Pharmaceutical Quality Assurance programme at VU the student will be able to : |
1 | Demonstrate a strong foundation in pharmaceutical analytical techniques, including UV spectroscopy, HPLC, and chromatographic methods for identifying, characterizing, quantifying, and purifying drug substances. Additionally, they will demonstrate mastery in advanced modern techniques such as NMR, IR, and Mass Spectrometry, equipping them with specialized knowledge in pharmaceutical quality assurance. Develop the ability to oversee the product development process from pre-formulation to pilot plant scale-up and effectively manage technology transfer from R&D to production or between manufacturing sites. They will also be proficient in implementing production planning, process automation, and ensuring adherence to production timelines and quality standards. |
2 | Apply quality management principles, including ISO standards, Total Quality Management (TQM), Six Sigma, and ICH guidelines, to analyze and solve problems related to product quality and regulatory compliance in the pharmaceutical industry. |
3 | Demonstrate proficiency in using modern pharmaceutical analytical techniques, including NMR, IR, Mass Spectrometry, and hyphenated techniques. They will also be skilled in the use of advanced analytical instruments like UV-Vis spectrophotometers, HPLC, and flame photometry to perform quality control tests on raw materials, in-process, and finished products. |
4 | Gain leadership and management skills necessary for overseeing pharmaceutical manufacturing processes, including sterile and non-sterile product manufacturing, while ensuring adherence to regulatory standards and quality assurance protocols. They will be able to lead teams, manage technology transfer, and oversee quality control and validation processes in manufacturing settings. |
5 | Develop a clear professional identity as quality assurance specialists in the pharmaceutical industry, recognizing their role in ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and international regulatory standards set by bodies such as the ICH, USFDA, and WHO. |
6 | Maintain ethical standards in pharmaceutical quality assurance, including the protection of intellectual property rights (IPR) such as patents, trademarks, and copyrights. They will also ensure ethical conduct during audits, compliance checks, and quality system maintenance. |
7 | Develop the ability to communicate effectively with regulatory bodies, management teams, and technical personnel during audits, regulatory inspections, and compliance assessments. They will also be proficient in writing reports and documentation in line with regulatory and cGMP standards. |
8 | Ensure the quality, safety, and efficacy of pharmaceutical products through their role in regulatory compliance, contributing to public health and societal well-being. Their expertise in pharmaceutical quality assurance will directly impact the safe distribution of pharmaceutical products. |
9 | Understand and implement safety management protocols to handle environmental, chemical, fire, and explosion hazards in pharmaceutical manufacturing settings, ensuring a safe working environment. They will also ensure that manufacturing processes adhere to environmental and sustainability standards. |
10 | Commit to continuous learning and professional development, staying updated with new technologies, regulatory changes, and evolving quality management practices. They will be proficient in implementing Quality by Design (QbD) and Process Analytical Technology (PAT) in product development, driving continuous quality improvement and innovation throughout their careers. |
Graduates of the M. Pharmacy (Pharmaceutical Quality Assurance) program have a wide range of career opportunities available to them in various sectors of the pharmaceutical industry. Career pathways include:
“A platform of knowledge and excellence means Vishwakarma University, School of Pharmacy. I believe that it is my best decision to be a part of Vishwakarma University. The most important factor about this institute is the infrastructure and teaching staff. Each and every faculty is a symbol of knowledge, passionate and bringing the best in each student. Along with teaching we also enjoy a lot of various co-curricular activities.
VU has a very much attentive attitude towards placement and training for students which is a great initiative and essential need in today's era. I really feel an attitude of gratitude for this educational system of Vishwakarma University and whole management.”
Samita Nikam, Student
“My experience in the VU School of Pharmacy is illuminating and rewarding. This institute provides me great opportunities to develop my educational skills. I am very much thankful to all faculties for grooming my skills and talent and teaching the values of ethics and morality which makes me proficient and competent."
Ashutosh Vitthal Gaikwad, Student
“Vishwakarma University, School of Pharmacy, prepares me for the independent and strong work ethics. VU faculty takes immense efforts for nurturing the students and making them more skilled. With great facilities at the pharmacy department and the best faculty members, students will pursue the path to become successful leaders in the field. Thank you very much for everything"
Mitali Sarlashkar, Student