Quality Standards
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 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 Management 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