Quality Assurance
- Our New facility has been designed as per existing Bestex Ingredients’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.
Bestex Ingredients 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
- 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
- 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
