Pharmaceutical Quality Assurance


Pharmaceutical Quality assurance (PQA) is a way of preventing mistakes and defects in Pharmaceutical manufactured products and avoiding problems when delivering products or services to customers. The quality assurance is a wide ranging concept covering all aspects of quality that individually or collectively influence the quality of the product. Assuring the product quality belongs mainly to quality assurance personnel but involves team effort. Also, by considering the current scenario of Pharmaceutical Industries, there is an immense need to fulfill the quality requirements of the products. 

This is a two year full-time course (Pharmaceutical Quality Assurance) was established in the year 2012. The objective was to train the pharmacy graduates in Quality Assurance to cater the ever-increasing need of pharmaceutical industry and academia. The course approved by Pharmacy Council of India, New Delhi, AICTE New Delhi and affiliated to RTMNU, Nagpur. The curriculum includes the basic elements of Quality Assurance, using the “Systems” approach as it applies to industry, starting with raw materials, through the stages of on-line production and packaging, to finished products and legislation. Emphasis is placed on an industrial orientation, together with laboratory skills and techniques required in industry. The Pharmaceutical Quality Assurance department housing all latest equipments required to conduct the practicals as per the curriculum and research to meet the current Industry demands. The department has qualified, dedicated, devoted faculty and are actively involved in the research activities.

No of Laboratories:         01: Pharmaceutical Quality Assurance lab-1                

                                           02: Pharmaceutical Quality Assurance lab-1                    

Area of each Laboratory:  78 sq.mtrs.

Equipment worth Total: Rs. Approximately 01 Crore

List of Equipment's:

IR spectrophotometer

Digital Potentiometer

Gas Chromatography

Digital Fluorimeter,

2 High Performance Liquid Chromatography (Shimatzu & Analytical Technologies)

Digital Polarimeter,

2 UV- Visible spectrophotometer (Shimatzu & Analytical Technologies)

Digital Nephaloturbidometer

Spectrofluorometer

Digital Melting Point apparatus

Colorimeter

Deep Freezier

Karl-Fischer Titrator

Hot air oven

Digital Flame photometer,

Single Distillation Unit

Digital pH Meter

Ultrasonicator

Digital Conductivity meter

Microwave oven

Research Interest:

Analytical and bio-analytical method development and validation of different drugs

Validation of equipments

Stability study of various dosage forms different drugs etc

Impurity Profiling

Research publications:

More than 25 publications in National and International reviewed journals. 

Thurst area-

Validation of equipments, process.

Herbal standardization

Analytical method development and validation

Bioanalytical method development and validation

Formulation development

Documentation

QbD

 

Services provided:

Analytical testing: Chromatographic analysis by HPLC. Photo stability testing, Accelerated stability testing, Herbal drug standardization.