Quality

  • Our New facility at Waddhamna has been designed as per existing Nitika’s quality standards meeting ICH Q7, EUGMP, IPEC, Excipact and WHO-TRS requirements.
  • Warehouse is designed with de- dusting area, movable sampling cum dispensing booth (in segregated areas), raw material storage area, finished goods storage area and rejected area.
  • Entry in the production & factory area is restricted. Gowning procedure is as per the SOP.
  • Processing area is provided with ventilation system ensuring pure filtered air.
  • Quality control Laboratory is adequately equipped with 21 CFR Compliant instruments to cater analytical requirements like Gas chromatography, Surface area Analyzer, FTIR, Atomic absorption spectroscopy etc.
  • Microbiology lab with class- 100000 (ISO-8) is equipped with laminar air flow (ISO-5), incubators, autoclaves, etc. to cater the microbial analytical requirements.
  • Separate Control sample storage area as per the ICH requirements.

Nitika has well established quality Management system procedures

  • Change control management
  • Deviation management
  • Market complaints
  • Internal audit
  • Process validation
  • Cleaning validation
  • Out of specification procedures
  • Batch manufacturing records
  • Batch release procedures
  • Equipment/Instrument qualification
  • Vendor qualifications
  • CAPAs
  • All activities are carried out as per the written procedures.
  • Training

Nitika has well established quality Control system procedures

  • Part 11 compliant instruments (GC/IR/AAS)
  • Incident procedures
  • Instrument calibration programme
  • SOPs and instrument usage log books for all the activities
  • Analytical data back up
  • Dedicated microbiology/wet lab and instrumentation area.
  • Analyst qualifications
  • Stability procedures
  • Training
  • User privileges and data back up procedures
  • Good chromatographic practices
  • Glass ware calibration
  • Raw material/packing material/finished product/stability testing
  • Control sample
  • Batch manufacturing records
  • Equipment qualifications
  • Equipment preventive maintenance, cleaning and usage logs.
  • Segregated processing areas for different operations
  • Entry procedure is restricted
  • Material receipt as per approved vendors
  • Segregated areas for Raw material/packing material/finished goods
  • Segregation for Quarantine/Approved and Rejected materials
  • Sampling and dispensing booth.
  • Distribution of finished goods

Following safety measures at Waddhamna facility:

  • Regular Fire fighting and mock drill training to all concerned.
  • Facility is equipped with Classified Fire fighting equipment
  • Safety Signage at appropriate locations
  • Personal protective equipment
  • Fire hydrant and sprinkler system
Chat with an Expert
1
Chat with an Expert
Hello...!!! Welcome to NITIKA Pharmaceuticals. How may i assist you today?