Department of Quality Assurance

"Passion of quality"

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 StudentYear% Marks
1Bodas Divyanka S.201780.38
2Badgujar Vaishali M.201681.01
3Garje Sunil V. 201577.53
4Rokade Deepak L. 201477.38
5Chaudhari Rashmi V.201377.46
6Bharucha Nikita K. 201279.31
7Shinkar Nikhil R.201177.46
8Goti Dharmesh B. 201074.33
9Dalal Kalpit P.200973.41
10Patil Ganesh B.200875.5
11Kakade Kavita M.200771.83

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.

Glimpses of Facilities available:


List of major Instruments available
at QA Department

List of major Software available
at QA Department
1. UV-Spectrophotometer1. Design Expert (version 8.0.1)
2. Differential Scanning Calorimeter (DSC)2. JMP -SAS (version 13.2.1)
3. HPLC3. Chemix (version 3.50)
4. Powder Flow Tester (PFT)4. Kinetica 5
5. Freeze and Spray dryer5. Shelf Life (Sigma Plot 12.5)
6. Brookfield Viscometer6. 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

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:

Sr. No Particulars Details
1Research Publications 230
2Books/ Chapters06
3Patents (Filed/Granted)02
4Seminar/FDP Organized04
5Grants Received (Lakhs)131
6Total Citations1100
7H-Index of Facility 50
8Cumulative Impact Factor90
9MOU3
10University Toppers (Gold Medallist)11

Departmental funding by various funding agencies

Funded Research Projects:

Sr. No.NameTitle
1.Mr. V. V. AgnihotriScale-up of multivitamin formulation
2.Dr. S. S. ChalikwarSoftware assisted design, development, optimization and characterization of lipidic nanoparticulate drug delivery system for enhancement of bioavailability
3.Dr. P. P. NerkarNon invasive nanoparticles based buccal drug delivery system for oral cancer treatment
4.Dr. A. D. KulkarniDevelopment of novel lipid based nano formulation of some bioactive polyphenols for the synergistic prophylactic treatment of cervical cancer
5.Dr. R. S. BhaskarDesign development and evaluation of nanoparticulate drug delivery system for poorly water soluble drugs
6.Dr. V. D. WaghFormulation development and evaluation of RUTF based nutraceutical formulations for severe malnutrition
7.Dr. V. D. WaghLocal medicinal plants based ready to use supplementary food formulations and their evaluation to combat child malnutrition
8.Dr. S. S. ChalikwarDesign, development, and characterization of floating drug delivery system for biphasic release: Estimation of shelf life
9.Dr. S. S. ChalikwarA study on quantitative standardization
10.Dr. S. G. GattaniMODROB : Modernisation and Removal of Obsolescence
11.Dr. V. S. BelgamwarDesign and development of nanoparticulate drug delivery system
12.Dr. A. R. TekadeFormulation and evaluation of multiparticulate pulsatile drug delivery system

Seminar / Conference/ Workshop / Staff Development Programs:

Sr. No.Coordinator TitleDate & Year Sponsored by
1.Dr. S. S. ChalikwarFostering platform of nanotechnology: Studies on formulation, pharmacodynamic and pharmacokinetic11/02/2017 NMU, Jalgaon
2.Dr. V. D. Wagh FDP: Recent advancement in herbal formulation and drug delivery system of Indian system of medicine27/05 - 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 system23 and 24/08/2008 AICTE, New Delhi

Patents:

Sr. No.ApplicantTitleApplication DateApp. 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 StudentsResearch Guide Project Titles
1Chaudhari Lalita SopanMr. R. S. BhaskarProcess validation of solid dosages form and recent approach to cleaning validation
2Chaudhari Mayur ArunDr. P. P. NerkarStability indicating RP-HPLC method development and validation of itopride
3Deore Kunal RajendraDr. P. P. NerkarStability indicating RP-HPLC method development and validation of danazol
4Kakade Ashwini MohanDr. P. S. JainMethod development and validation of three content amino acid estimation without derivatization method by RP-HPLC
5Kayande Satish DigambarDr. S. S. ChalikwarBioanalytical method development and validation of fumesartan by HPLC
6Mohammad Mudassar Abdul G.Mr. R. S. BhaskarStability indicating method development and validation of sildenafil citrate
7Narkhede Mahesh SureshDr. S. D. FirkeAnalytical method development and validation of lamotrigine by HPLC and HPTLC
8Padmor Satilal BhagwanDr. P. P. NerkarStability indicating RP-HPLC method development and validation of ranolazine
9Patil Chetan VikasDr. P. P. IgeAnalytical method development and validation of linagliptin
10Patil Harshal IndrabhanDr. P. P. IgeAnalytical method development and validation of sodium faropenem in bulk and ER tablet
11Patil Jagruti RajendraDr. R. R. PatilMethod development and validation of stability indicating RP-HPLC method for hydroxychloroquine sulphate in pharmaceutical solid dosage form
12Phad Ram DnyanobaDr. S. S. ChalikwarQuality by design (QbD) assisted development of oral fast dissolving film for antihypertensive drug
13Shimpi Prashik Sudhir Dr. H. S. MahajanBioanlytical method development and validation of tadalafil in human plasma using HPLC
14Sonawane Shubham ChhotusaMr. A. D. KulkarniStability indicating assay, dissolution method development and validation of raloxifene hydrochloride tablet dosage form
15Bagal Dipali GambhirraoDr. S. C. KhadseDevelopment and validation of stability indicating assay method for dalfampridine in bulk drug and tablet dosage form and its application in dissolution by RP-HPLC
16Bhamare Nitin KisanDr. H. S. MahajanDevelopment and validation of stability indicating assay method for tolvaptan by using HPLC
17Dhivare Tarkeshwari KundanMs. Monika OlaQuantitative estimation of edoxaban using UV and HPTLC technique
18Girase Rameshwari RamsingDr. A. A. ShirkhedkarDevelopment and validation of stability indicating RP-HPLC method for nebulizer dosage form containing bronchodilator drug
19Jayswal Shubham DineshDr. S. S. ChalikwarAnalytical method development and validation of mifipristone by UV and HPLC
20Mahajan Jayashri SunilDr. A. P. GorleDevelopment and validation of analytical method for determination of desoximetasone in bulk and cream formulation
21Mali Rinku RajendraDr. A. P. GorleAnalytical method development and validation of linezolid by RP-HPLC and UV spectrophotometric methods for estimation in bulk and pharmaceutical dosage formulations
22Patil Bhagyshri RavindraMs. Monika OlaDevelopment and validation of stability indicating of analytical method for estimation of midodrine hydrochloride in oral solution by RP-HPLC method
23Patil Dinesh BaluDr. A. P. GorleDevelopment and validation of stability indicating RP-HPLC method for assay of mycophenolic acid in tablet dosage form.
24Patil Paresh AshokDr. P. P. IgeFormulation and evaluation of enteric coated multiple unit pellets of metronidazole
25Patil Pritam BhagwanMr. R. O. SonewaneAnalytical method development and dissolution of penicillamine drug by HPLC
26Pawar Rishikesh ChandrakantMr. R. S. BhaskarDevelopment and validation of analytical methods for determination of mometasone fumarate
27Pendharkar Ashwini VijayMs. Monika OlaDevelopment and validation of stability indicating analytical method for estimation of vildagliptin and metformin drug in solid dosage form by RP-HPLC
28Rane Snehal AshokDr. Y. O. AgrawalDevelopment and characterization of acitretin loaded solid lipid nanoparticles
29Suryawanshi Prajakta RavindraMr. R. O. SonewanePreparation and evaluation of immediate release pellets
30Wadile Rupesh AmrutDr. S. S. ChalikwarDevelopment and validation of stability indicating RP-HPLC method for assay of trospium chloride in IR tablet dosage form
31Waghe Dipali ChintamanDr. Y. O. AgrawalAnalytical 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.

PROGRAM

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.

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:

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
• Validation
• Regulatory Affairs

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.

Our Recruiters: