Quality

Quality Control  
In order to assure zero rejection of its product, Nivika has put forward utmost efforts by providing latest sophisticated instruments, training and developing entire team continuously to not only meet but excel the standards set by international regulatory bodies and customers.
In-house testing facility at Nivika comprises of the Instruments such as HPLC, GC, with headspace, DSC, FTIR, Laser based Partical Size Analyser, UV-Visible Spectrophotometer, Polarimeter, Colorometer; Auto Titrator etc. Over and above it also has facility to conduct long term and short term stability studies as well as full-fledged Microbiology department.
For other special testing requirements such as X-ray diffraction and NMR, Nivika takes the support of government recognized laboratories.
Quality Control
   
Quality Assurance  

Nivika preserves a tradition of dedication and professional integrity in the pursuit of excellence by performing systematic and planed activities to enable our organization to better compete with others. Below are the features of Quality assurance.
Department at Nivika:

  • Quality assurance is independent of Manufacturing and Quality control.
  • In-process quality is checked during manufacturing.
  • Validation of facilities, equipments, process, products and cleaning as per master plan.
  • Responding Complaints.
  • Handling audits of customers and regulatory bodies.
  • Storage of records and samples.
  • Stability studies.
  • Documentation control.
  • cGMP Traing.
  • Release of batch for marketing
  • Conducting Supplier Audit as well as Internal Audit
Quality Assurance
   
Regulatory Affairs  
With focus to cater consistently to the highly regulated markets of European Union, USA and Japan, Nivika has developed regulatory affairs department comprising of qualified and experienced persons in the field. Regulatory affairs at Nivika takes care for registration of products, submission of drug master files etc. , by co-ordinating with all the departments including top management. It plays a significant role in keeping up to date with latest registration requirements of different countries.