Vision
-
An Outstanding Department of Excellence in pursuit of newer horizons through Quality Education, Training & Research.
Mission
-
To achieve academic excellence by educating and training the aspirants.
-
To establish Industry and Academic Collaborations at Regional, National and International level.
-
To extend the frontiers of knowledge through faculty development and continuing education programmes.
OBJECTIVES
► To train the post graduate students to ensure high competence in the field and prepare them for career in industry, research and academics.
► To achieve high degree of proficiency in research through publications and scientific presentations at various platforms.
► To foster professional honesty and integrity, develop oral and written communication skills, leadership skills with high moral and ethical standards.
The Pharmaceutical Quality Assurance Post Graduation programme was established in the year 2009 at KLE College of Pharmacy, Belagavi to cater to the needs of Pharmaceutical Industry. PQA is the heart of pharmaceutical industry and we mainly emphasize on training our students to understand the functions of quality assurance, documentation, control the manufacturing process, assuring the quality of the products and recognize regulatory requirements of different regulatory bodies.
The department deals with all the aspects of design, development, production, installation, servicing, audits, regulatory aspects, market complaints and documentation in pharmaceutical firms. The two key principal characters of PQA are “Fit for purpose” (the product should be suitable for the intended purpose) and “right first time” (mistakes should be eliminated).
More than 130 students have successfully completed their Post-Graduation with excellent results and are well placed in pharmaceutical sector in India and abroad.
Well-trained faculty with vast experience in academics, industry and research ensure the quality of education and training to the students. The department conducts research in the area of analytical method development and validation by QbD approach, drug impurity profiling, nano-technology, formulation development and poly-herbal formulation.
Departmental Research Thrust Areas
-
To develop new analytical method and its validation for pure drug and formulations.
-
Formualtion and evaluation of novel drug delivery system
-
Quality Assurance of various pharmaceutical packaging.
-
Implementation of Quality by Design approach in the development of formulations and analytical methods.
-
To carryout Stability studies for the prepared formulations.
Outcomes: Publications
Total Publications since Last five years: 24
National: 19
International: 05
Impact factor ranges from 1.697 to 4.128
Career choices in Pharmaceutical Quality Assurance
-
Quality Assurance officer in pharma industry
-
Regulatory Affairs
-
Regulatory Consultant
-
Quality Project Management
-
Document Controller
-
Quality Assurance Team Leader
-
Specific validation officer
-
Third party Auditors
-
Academics
-
Government Sector
-
Entrepreneurship
-
Industry consultant
Instruments available in the department
HPLC System Auto Sampler with PDA Detector, Agilent 1220 Infinity
Particle size Analyzer and Zeta meter (Malvan)
Refrigerated Ultra-Centrifuge, Hanil Science industrial, Supra 30K, South Korea
Kalvika Equipment- Main Drive with assembly
Rimek Rotary 10 station tablet press
UV Spectrophotometer 1900
Value Added course on Drug Regulatory Affairs
Pharmaceutical Regulatory Affairs is an emerging specialized discipline that is vital in successfully delivering a safe and effective product to the market. It is the key player in drug development and their approval by taking into account the global laws and regulations. It also plays an important role in bringing about new policy implementation and research. Helps in developing writing skills to fill dossier for various products across the globe with due consideration of the respective legalities.
Course Objectives:
This course is designed to impart advanced knowledge and skills required to learn the concept of generic drug and their development, various regulatory filings in different countries, different phases of clinical trials and submitting regulatory documents: filing process of IND, NDA and ANDA.
Duration: 24 Hrs
Department Professional Activities
Publications: 24
Presentations: 01
Ph. D Awarded: 02
Honors/ Awards & Recognitions: 05
Industrial training by faculty: 02
QIP Conducted: 02
Workshops Conducted: 06
Guest Lectures Conducted: 09
Conference/ Workshop Attended: Faculty- 55 PG’s & PhD’s students: 43
Extension & Extramural activity: 10
