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Wednesday, February 20, 2013

Report on Nuvista Pharma Ltd (Part-12)

QUALITY CONTROL DEPARTMENT of Nuvista Pharma Ltd

Quality Operation Department is very important for a pharmaceutical industry to maintain GMP. The concept of total quality management and total quality control refers to the process of striving to produce a perfect product by a series of measures requiring an organized effort by the entire company to prevent or eliminate errors at every stage in production.

Although the responsibility for assuring product quality belongs principally to QOD, it involves many departments and disciplines within the company. To be effective it must be supported by a team effort.

The QOD is vital for a pharmaceutical industry since it controls and assures for quality of the products starting from the raw materials to the finished product till the customers consume it. All kinds of necessary steps are taken by this department to serve a quality product to the end users.
QUALITY OPERATION


Equipment or instruments used for Quality Operation:

  • Hardness Tester, Model: B 24, Western Germany.
  • Friability Tester, Model: T A Fed. Rep. Germany.
  • Vaccum Oven
  • UV
  • Dissolution Tester
  • Disintegration Tester
  • Ultrasonic Bath
  • Viscometer   
  • Karl-Fischer Titrator
  • Analytical Balance.
  • Centrifuger
  • High Performance Liquid Chromatography (HPLC)

Quality Assurance


In addition to day to day production also matter day to day. It concerns original design and development product distribution, dispensing upto the administration to the patients Nuvista Pharma Limited gives priority to produce quality product. They believe that only quantity product can satisfy the consumer and a satisfied customer is a great advertiser for the company. For this reason they have taken a stick and inflexible process to check the product for erosion of any kind of defects. For Quality control Nuvista procures Quality raw Materials from their approved source.

Types of work of QA:

1)      Raw materials analysis
Ø     Source development
Ø     Commercial Consignment
Ø     Re-testing
Ø     Keeping sample & relevant documentation
2)      Packaging material analysis
Ø    Source development
Ø    Commercial Consignment
3)    Finish product analysis
Ø    In process
Ø    Bulk product
4)   Water analysis
5)   Calibration
6)      Validation
7)      Packed Product analysis
8)      In Process
9)      Packet product
10)  Stability study
11)  Product monitoring
12)  Environmental monitoring
13)  Dust monitoring
14)  Documentation

Flow Chart of Releasing Finished Product:

Flow Chart of Releasing Finished Product: