DEPARTMENT OF QUALITY ASSURANCE

“We don’t believe in doing things right, we believe in doing right things”

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:

Sr. NoParticularsDetails
1Research Publications230
2Books/ Chapters06
3Patents (Filed/Granted)02
4Seminar/FDP Organized04
5Grants Received (Lakhs)131
6Total Citations1100
7H-Index of Facility50
8Cumulative Impact Factor90
9MOU3
10University Toppers (Gold Medallist)11

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.

  1. 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:

  1. 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
  • 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.

QA Pentagon

GPAT Crackers – Quality Assurance Department

Sr. No.

Name of Student

NTA Score

Marks

All India Rank

Year

1

Kamalja Mahesh D.

92.02

137

2773

2017-18

2

Bansod Buddhbhushan V.

86.71

118

4616

2017-18

3

Khairnar Roshni B

85.53

115

5026

2017-18

4

Joshi Aditya A

98.74

176

512

2018-19

5

Randhir Nikhil K

93.9

134

2478

2018-19

6

Marathe Sopan R

88.55

1174

4652

2018-19

7

Manatkar Suraj B

97.60

178

1188

2019-20

8

Lonkar Vijay D

90.55

134

4619

2019-20

9

Shinde Shital B

77.49

104

10910

2019-20

SWOT Analysis of the Department

CORE COMPETENCIES

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

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.CoordinatorTitleDate & YearSponsored by
1.Dr. S. S. ChalikwarFostering platform of nanotechnology: Studies on formulation, pharmacodynamic and pharmacokinetic11/02/2017NMU, Jalgaon
2.Dr. V. D. WaghFDP: Recent advancement in herbal formulation and drug delivery system of Indian system of medicine27/05 – 08/06/2013AICTE, New Delhi
3.Dr. V. D. WaghAYUSH: Current trends and recent advancements on herbal formulations21 – 22/02/2012Department of AYUSH, Ministry of Health and Family Welfare, Govt. India
4.Dr. S. G. GattaniCurrent trends in novel drug delivery system23 and 24/08/2008AICTE, New Delhi

Patents:

Sr. No.ApplicantTitleApplication DateApp. Number
1.Dr. P. P. NerkarSprayable in situ gel forming wound dressing14/01/2014125/MUM/2014
2.Dr. R. S. BhaskarNovel antitubercular drug delivery systems utilizing liquid crystal mesophase25/04/2017TEMP/E-1/14862/2017-MUM

Glimpses of Facilities Available

Sr. No.

Instrument Name

Manufacturer/Company

Model

Qty

1

XRD

Bruker India Scientific

D2 Phaser

1

2

UV-Spectrophotometer

Shimadzu, Japan

UV-1900

1

3

HPLC

Agilent Technology, Germany

PDA Detector

1

4

Differential Scanning Calorimeter (DSC)

Metter Toledo Pvt. Ltd., Switzerland

STARe Thermal Analysis

Software Ver.10

1

5

Powder Flow Tester

Brookfield Eng, Lab USA

PFT Sr. No. 8680044

1

6

Rotary Evaporator

With Chiller

Knf Pumps + System (India) Pvt. Ltd

H-D-A-E RC600

1

7

Student Microscope

With Fixed Condenser

Besto

Model 6

5

8

Digital pH Meter

Equiptronics

Model EQ612

1

9

Rheometer

Brookfield Eng, Lab USA

RST-CC

1

10

Diffusion Cell Apparatus

Electrolab, Mumbai

EDC-07

1

11

Cascade Impactor

Thermo fisher Scientific USA

N-V 8 Stage Series20-800

1

12

Dissolution Tester

Electrolab, Mumbai

TDT-08L

3

13

Centrifuge

Remi Motor, Mumbai

2

List of Major Software Available at Quality Assurance Department

1. Design Expert (version 8.0.1)

2. JMP -SAS (version 13.2.1)

3. Chemix (version 3.50)

4. Kinetica 5 (Demo version)

5. Shelf Life (Sigma Plot 12.5)

6. PCP Disso (version V3i)

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

Sr. No.

Name of the Student

Year

% Marks

1

Baheti Nupur Suresh

2020

98.82

2

Zahid Anwer Ansari

2019

92.93

3

Girase Rameshwari R.

2018

81.07

4

Bodas Divyanka S.

2017

80.38

5

Badgujar Vaishali M.

2016

81.01

6

Garje Sunil V.

2015

77.53

7

Rokade Deepak L.

2014

77.38

8

Chaudhari Rashmi V.

2013

77.46

9

Bharucha Nikita K.

2012

79.31

10

Shinkar Nikhil R.

2011

77.46

11

Goti Dharmesh B.

2010

74.33

12

Dalal Kalpit P.

2009

73.41

13

Patil Ganesh B.

2008

75.5

14

Kakade Kavita M.

2007

71.83