DEPARTMENT OF QUALITY ASSURANCE

ABOUT THE DEPARTMENT

The department started functioning in the year 2005, having intake of 15 students (Academic Year 2020-21) and it has high end sophisticated instruments like XRD, DSC, Powder Flow Tester, Ultracentrifuge, HPLC systems with various detectors including UV and PDA, UV Visible spectrophotometers, FTIR spectrophotometer. These facilities serve both industry and academic research. The Department of Quality Assurance is the only department among academic institution to have facilities to undertake parallel stability testing program at various climatic zone conditions as per ICH guidelines. The department is being headed by Dr. S. S. Chalikwar.

The students are provided with GMP and GLP compliant environment, ready to take up analytical, regulatory and quality functions in any industry. The department is passionate with a strong belief that QUALITY is never an accident, but it is the result of planning, team work and commitment to excellence. The department is active in creating new knowledge by way of continuous interaction with industrial expertise.

The department regularly runs industrial projects in the area current perspective of pharmaceutical industries like Analytical Method Validation, Process validation, Sterile Process Validation, Cleaning validation. Quality by design (QbD) and Design of the experiments (DOE) are the currently explored areas for development of novel drug delivery system under research project works.

The department had over 300+ alumni spread across the leading pharma industries in India and abroad and they have reached the epitome of career and occupy key upper managerial positions. They are in constant touch with the department contributing to the placements, sharing existing regulatory updates and development.

Thus Department of Quality Assurance is the dream destination for an aspiring graduate to obtain M. Pharm. in Quality Assurance.

GLIMPSES OF THE DEPARTMENT

ABOUT THE DEPARTMENT

Key Features

• State of the art facility.
• Diversified capabilities.
• Team of academicians with rich industry exposure.
• Specialized and focused validation and analytical services.
• Advance packaging quality control facilities.

Core Competencies:

• Expertise in pharmaceutical documentation program and regulatory affairs.
• Pharmacokinetic studies.
• Development of Standard Operating Procedures, Validation Protocols and Reports

Research contribution, funding and achievements of department:

PHARM QUALITY ASSURANCE

The Department of Quality Assurance offers postgraduate program M. Pharm. Quality Assurance (Pharmaceutical Quality Assurance i.e. as per new PCI syllabus). The curriculum of M. Pharm. Quality Assurance is designed for a period of two years, providing theoretical and practical exposure to core and fundamental subjects during the program along with research (project) work.

OBJECTIVE:

To train the students to be competent, honest, industry ready quality professionals in order to meet the requirements of pharmaceutical industry in present contest.

SCOPE

Pharm.(Quality Assurance) had gigantic and varied scope. It includes various facets of formulation development like analytical research and stability testing, bioanalytical method development and validation. Regulatory functions like documentation, review regulatory guidelines including USFDA, ICH, MCC, TGA etc. Dossier preparation and maintenance for regulated and semi regulated markets, Quality functions like quality system designs, planning and execution like quality control and quality assurance. Campus recruitments are held annually and there is 100% placement every year in renowned multinational companies.

Job prospects for Pharmaceutical Quality Assurance Personals:

• Quality Assurance
• Quality Assurance
• Validation
• Regulatory Affairs
• Analyst
• Academics- University Approved Teacher
• Store
• ADL
• Corporate QA
• Warehouse
• Audit & Regulatory Compliance
• IPQA & IPQC
• Analytical Research & Development (ARD)
• Stability Testing

Placement

The department of Quality Assurance strives hard to train the students in niche areas of pharmaceutical quality assurance and make them competent to take up jobs in pharma companies in quality control, quality assurance, validation and analytical development laboratory.

GPAT Crackers

Perspective Plan of the Department

• Lectures on special topics by personnel invited from industries.
• Training modules to improve the soft skills of students.
• Creating a research-oriented culture for the budding scientists.
• Procurement of ultramodern instruments e.g. SEM-TEM, UPLC.
• Inclusion of a few additional Value added courses.

Unbeatable History of University Toppers and Gold Medallist of Department

CORE COMPETENCIES

• Expertise in Pharmaceutical Documentation Program and Regulatory Affairs.
• Pharmacokinetic Studies.
• Development of Standard Operating Procedures, Validation Protocols and Reports

Patents

Glimpses of Facilities Available

List of major Instruments available at QA Department

• X-ray Diffractmeter (XRD)
• Differential Scanning Calorimeter (DSC)
• HPLC
• Powder Flow Tester (PFT)
• Freeze and Spray dryer
• Brookfield Viscometer
• Particle Size Analyser
• Diffusion and Dissolution Apparatus
• Rotary Evaporator
• Cascade Impactor
• Hot High Pressure Homogenizer
• Cold High Pressure Homogenizer
• High-Speed Homogenizer
• Extruder and Spheronizer
• Palm Glatt Coater
• Stability Chambers
• UV-Spectrophotometer
• State-of-the-Art Pilot Plant
• Aseptic Room (Class 10000)
• Bilayer Rotatry Tablet Machine

List of Major Software Available at Quality Assurance Department

• Design Expert (version 8.0.1)
• JMP –SAS (version 13.2.1)
• Chemix (version 3.50)
• Kinetica 5
• Shelf Life (Sigma Plot 12.5)
• PCP Disso (version V3i)