About the Department of Quality Assurance
The department started functioning in the year 2005, having intake of 33 students and it has high end sophisticated instruments like DSC, Ultracentrifuge, UV Visible spectrophotometers, FTIR spectrophotometer, HPLC systems with various detectors including UV and PDA. 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 etc. Quality by design (QbD) and Design of the experiments (DOE) are the currently explored areas for 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.
Unbeatable History of University Toppers and Gold Medallist:
|Sr. No. ||Name of the Student||Year||% Marks|
|1||Bodas Divyanka S.||2017||80.38|
|2||Badgujar Vaishali M.||2016||81.01|
|3||Garje Sunil V. ||2015||77.53|
|4||Rokade Deepak L. ||2014||77.38|
|5||Chaudhari Rashmi V.||2013||77.46|
|6||Bharucha Nikita K. ||2012||79.31|
|7||Shinkar Nikhil R.||2011||77.46|
|8||Goti Dharmesh B. ||2010||74.33|
|9||Dalal Kalpit P.||2009||73.41|
|10||Patil Ganesh B.||2008||75.5|
|11||Kakade Kavita M.||2007||71.83|
• 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.
Glimpses of Facilities available:
List of major Instruments available
at QA Department
List of major Software available
at QA Department
|1. UV-Spectrophotometer||1. Design Expert (version 8.0.1)|
|2. Differential Scanning Calorimeter (DSC)||2. JMP -SAS (version 13.2.1)|
|3. HPLC||3. Chemix (version 3.50)|
|4. Powder Flow Tester (PFT)||4. Kinetica 5|
|5. Freeze and Spray dryer||5. Shelf Life (Sigma Plot 12.5)|
|6. Brookfield Viscometer||6. PCP Disso (version V3i) |
|7. Particle Size Analyser|
|8. Diffusion and Dissolution Apparatus|
|9. Rotary Evaporator|
|10. Cascade Impactor|
|11. High Pressure Homogenizer|
|12. Extruder and Spheronizer|
|13. Palm Glatt Coater |
|14. Stability Chambers|
• 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:
|Sr. No ||Particulars ||Details |
|1||Research Publications ||230|
|5||Grants Received (Lakhs)||131|
|7||H-Index of Facility ||50|
|8||Cumulative Impact Factor||90|
|10||University Toppers (Gold Medallist)||11|
Departmental funding by various funding agencies
Funded Research Projects:
|1.||Mr. V. V. Agnihotri||Scale-up of multivitamin formulation|
|2.||Dr. S. S. Chalikwar||Software assisted design, development, optimization and characterization of lipidic nanoparticulate drug delivery system for enhancement of bioavailability|
|3.||Dr. P. P. Nerkar||Non invasive nanoparticles based buccal drug delivery system for oral cancer treatment|
|4.||Dr. A. D. Kulkarni||Development of novel lipid based nano formulation of some bioactive polyphenols for the synergistic prophylactic treatment of cervical cancer|
|5.||Dr. R. S. Bhaskar||Design development and evaluation of nanoparticulate drug delivery system for poorly water soluble drugs|
|6.||Dr. V. D. Wagh||Formulation development and evaluation of RUTF based nutraceutical formulations for severe malnutrition|
|7.||Dr. V. D. Wagh||Local medicinal plants based ready to use supplementary food formulations and their evaluation to combat child malnutrition|
|8.||Dr. S. S. Chalikwar||Design, development, and characterization of floating drug delivery system for biphasic release: Estimation of shelf life|
|9.||Dr. S. S. Chalikwar||A study on quantitative standardization|
|10.||Dr. S. G. Gattani||MODROB : Modernisation and Removal of Obsolescence|
|11.||Dr. V. S. Belgamwar||Design and development of nanoparticulate drug delivery system|
|12.||Dr. A. R. Tekade||Formulation and evaluation of multiparticulate pulsatile drug delivery system|
Seminar / Conference/ Workshop / Staff Development Programs:
|Sr. No.||Coordinator ||Title||Date & Year ||Sponsored by|
|1.||Dr. S. S. Chalikwar||Fostering platform of nanotechnology: Studies on formulation, pharmacodynamic and pharmacokinetic||11/02/2017 ||NMU, Jalgaon |
|2.||Dr. V. D. Wagh ||FDP: Recent advancement in herbal formulation and drug delivery system of Indian system of medicine||27/05 - 08/06/2013 ||AICTE, New Delhi|
|3.||Dr. V. D. Wagh ||AYUSH: Current trends and recent advancements on herbal formulations ||21 - 22/02/2012 ||Department of AYUSH, Ministry of Health and Family Welfare, Govt. India|
|4.||Dr. S. G. Gattani ||Current trends in novel drug delivery system||23 and 24/08/2008 ||AICTE, New Delhi|
|Sr. No.||Applicant||Title||Application Date||App. Number|
|1.|| Dr. P. P. Nerkar || Sprayable in situ gel forming wound dressing ||14/01/2014 || 125/MUM/2014|
|2.||Dr. R. S. Bhaskar ||Novel antitubercular drug delivery systems utilizing liquid crystal mesophase ||25/04/2017 ||TEMP/E-1/14862/2017-MUM|
M.Pharm Dissertation titles for current academic year (2017-18):
|Roll No.||Name of Students||Research Guide ||Project Titles|
|1||Chaudhari Lalita Sopan||Mr. R. S. Bhaskar||Process validation of solid dosages form and recent approach to cleaning validation|
|2||Chaudhari Mayur Arun||Dr. P. P. Nerkar||Stability indicating RP-HPLC method development and validation of itopride|
|3||Deore Kunal Rajendra||Dr. P. P. Nerkar||Stability indicating RP-HPLC method development and validation of danazol|
|4||Kakade Ashwini Mohan||Dr. P. S. Jain||Method development and validation of three content amino acid estimation without derivatization method by RP-HPLC|
|5||Kayande Satish Digambar||Dr. S. S. Chalikwar||Bioanalytical method development and validation of fumesartan by HPLC|
|6||Mohammad Mudassar Abdul G.||Mr. R. S. Bhaskar||Stability indicating method development and validation of sildenafil citrate|
|7||Narkhede Mahesh Suresh||Dr. S. D. Firke||Analytical method development and validation of lamotrigine by HPLC and HPTLC|
|8||Padmor Satilal Bhagwan||Dr. P. P. Nerkar||Stability indicating RP-HPLC method development and validation of ranolazine|
|9||Patil Chetan Vikas||Dr. P. P. Ige||Analytical method development and validation of linagliptin|
|10||Patil Harshal Indrabhan||Dr. P. P. Ige||Analytical method development and validation of sodium faropenem in bulk and ER tablet|
|11||Patil Jagruti Rajendra||Dr. R. R. Patil||Method development and validation of stability indicating RP-HPLC method for hydroxychloroquine sulphate in pharmaceutical solid dosage form|
|12||Phad Ram Dnyanoba||Dr. S. S. Chalikwar||Quality by design (QbD) assisted development of oral fast dissolving film for antihypertensive drug|
|13||Shimpi Prashik Sudhir ||Dr. H. S. Mahajan||Bioanlytical method development and validation of tadalafil in human plasma using HPLC|
|14||Sonawane Shubham Chhotusa||Mr. A. D. Kulkarni||Stability indicating assay, dissolution method development and validation of raloxifene hydrochloride tablet dosage form|
|15||Bagal Dipali Gambhirrao||Dr. S. C. Khadse||Development and validation of stability indicating assay method for dalfampridine in bulk drug and tablet dosage form and its application in dissolution by RP-HPLC|
|16||Bhamare Nitin Kisan||Dr. H. S. Mahajan||Development and validation of stability indicating assay method for tolvaptan by using HPLC|
|17||Dhivare Tarkeshwari Kundan||Ms. Monika Ola||Quantitative estimation of edoxaban using UV and HPTLC technique|
|18||Girase Rameshwari Ramsing||Dr. A. A. Shirkhedkar||Development and validation of stability indicating RP-HPLC method for nebulizer dosage form containing bronchodilator drug|
|19||Jayswal Shubham Dinesh||Dr. S. S. Chalikwar||Analytical method development and validation of mifipristone by UV and HPLC|
|20||Mahajan Jayashri Sunil||Dr. A. P. Gorle||Development and validation of analytical method for determination of desoximetasone in bulk and cream formulation|
|21||Mali Rinku Rajendra||Dr. A. P. Gorle||Analytical method development and validation of linezolid by RP-HPLC and UV spectrophotometric methods for estimation in bulk and pharmaceutical dosage formulations|
|22||Patil Bhagyshri Ravindra||Ms. Monika Ola||Development and validation of stability indicating of analytical method for estimation of midodrine hydrochloride in oral solution by RP-HPLC method|
|23||Patil Dinesh Balu||Dr. A. P. Gorle||Development and validation of stability indicating RP-HPLC method for assay of mycophenolic acid in tablet dosage form.|
|24||Patil Paresh Ashok||Dr. P. P. Ige||Formulation and evaluation of enteric coated multiple unit pellets of metronidazole|
|25||Patil Pritam Bhagwan||Mr. R. O. Sonewane||Analytical method development and dissolution of penicillamine drug by HPLC|
|26||Pawar Rishikesh Chandrakant||Mr. R. S. Bhaskar||Development and validation of analytical methods for determination of mometasone fumarate|
|27||Pendharkar Ashwini Vijay||Ms. Monika Ola||Development and validation of stability indicating analytical method for estimation of vildagliptin and metformin drug in solid dosage form by RP-HPLC|
|28||Rane Snehal Ashok||Dr. Y. O. Agrawal||Development and characterization of acitretin loaded solid lipid nanoparticles|
|29||Suryawanshi Prajakta Ravindra||Mr. R. O. Sonewane||Preparation and evaluation of immediate release pellets|
|30||Wadile Rupesh Amrut||Dr. S. S. Chalikwar||Development and validation of stability indicating RP-HPLC method for assay of trospium chloride in IR tablet dosage form|
|31||Waghe Dipali Chintaman||Dr. Y. O. Agrawal||Analytical method development and validation of olmesartan medoxomil|
Awards and Honours:
• NMU Sponsored National Conference
• Elsevier Nimodipine Research Presentation
• Invited Resource Person
• Best Teacher Award
• Avishkar State Level 2017, 2015, 2013 and 2010.
M. 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.
To train the students to be competent, honest, industry ready quality professionals in order to meet the requirements of pharmaceutical industry in present contest.
M. 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 Control
• Regulatory Affairs
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.