NCQC is having leading name for Calibration and Validation in India and globally. We had team of experts providing consultancy for ISO 13485, CE mark all types of ISO certification, NABL accreditation as well as GMP and based on such expertise experience we are helping to pharmaceutical companies for calibration and validation and it is accepted by US FDA and all compliance audits. We are providing the total solution for calibration of all the types of instruments used in pharmaceutical industries and validation for any types of equipment.
We had huge facility for instrument calibration and accredited by NABL since 2000 as well as our customers are like Zydus, Alkem, IPCA, Qatar Pharma, Intas, MCleods pharma, Gujarat themis, United phosphors, India gelatin, Amneal, Rushan etc., leading pharmaceutical brands. Our laboratory is having controlled temperature and full facility to calibrate E2 class of weights as well as full facility for any types of validation in the Pharma and process industries. Our validation reports are generated by our highly imported machines to meet US FDA requirements and other compliance audit.
NCQC had a team of electronics and instrument engineers having very rich experience for software validation. With NCQC, many leading pharma companies of India are doing software validation for their PLC and HMI or SCADA based system or APS system of auto filling and packing and having leading name for the same. Majority of pharmaceuticals companies are in list of our clients and with our calibration and validation reports they had successfully completed their US FDA, GMP and other compliance audits for many years.
Validation
| Clean Room validation |
HVAC Validation |
AHU Validation |
| Laminar air Flow |
Air flow Test & ACPH Calculations |
Installed Filter System Leakage Test |
| Smoke test |
Non-Viable Particle Count Test |
Recovery Test |
| Air Flow Pattern Test (Using Water Fogger) |
Air Flow Pattern Test (Using Water Fogger) |
Light Intensity Measurement |
| Sound Level Measurement |
Ventilation measurement |
Air capture hood measurement |
Software Validation
Installation qualification, operational qualification and performance qualification of software based equipments based on the requirements of GAMP as per the requirements of US FDA.
| PLC and HMI validation |
SCADA validation |
BMS (Building Maintenance System) Validation |
| SAP Validation |
ERP Validation |
EMS Validation |
OSD
| Blender | Rapid Mixture granulator | Auto water |
| FBD Blister | packaging Machine |
Injectable
| Vial washing | Vial feeling |
| Autoclave | Tunnel |
Utility
| RO + UV water |
Purified water generation and siatillation |
Instrument Calibration
| Thermo-Hygrometer | Weight Box (E2 Class and coarser) | Temperature controller / Indicator |
| Autoclave Mapping | Micro pipettes | ORP Meter |
| Temperature Mapping | Weighing balance | Data Loggers |
| Humidity Mapping | Glass wares | Safety Valve |
| Incubator | Hydrometer | Magnahilic Gauge |
| Oven | Measuring scale | Manometer |
| Glass thermometer | Caliper | Pressure gauges |
| Thermocouples / Temperature Sensor | Wobble meter | Compound gauges |
| Muffle Furnace | Dial gauge | Pressure recorder |
| Anemometer | Lux Meter | Hot-Wire anemometer |
| Temperature recorder | Temperature transmitter | Pressure Transmitter |
| Humidity transmitter | Test sieve Dial | Gauge |
