At CellArtgen Lab Pvt. Ltd., our Quality Assurance team ensures that quality is built into every process and system — not just inspected at the end. QA is the foundation of our credibility, customer confidence, and long-term growth.
Quality Assurance is the maintenance of a desired level of quality through systematic attention to every stage of production and delivery. Our QA team establishes and maintains defined requirements for developing and manufacturing reliable pharmaceutical products.
“Quality is not an act — it is a habit embedded in everything we do.”
All ventilation filters at our facility are monitored continuously and replaced as per defined Standard Operating Procedures whenever the pressure drop across filters deviates from the design range. This ensures a fully contamination-free manufacturing environment at all times.
Waste management at our facility is handled responsibly through authorized agencies, ensuring full environmental compliance and safe disposal of all manufacturing by-products.
Our purified water system is a multi-stage treatment process consisting of Raw Water Tanks, Sand Filtration, Softening, Reverse Osmosis (RO), Mixed Bed, and UV treatment. Purified Water Generation capacity is 2000 L/Hr, meeting IP/BP/USP standards.
Purified water is distributed through a closed loop system to all production and laboratory areas, ensuring consistent quality and zero contamination risk throughout the facility.
All Air Handling Units and Water Treatment Plants are maintained under a structured Annual Preventive Maintenance Plan. Maintenance activities are carried out as per defined SOPs, and all records are documented systematically for complete traceability and compliance.
All manufacturing equipment is designed, installed, and maintained as per cGMP guidelines. Every equipment undergoes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) before use in production.
All product contact parts are made of SS316 Stainless Steel. Measuring devices are calibrated against certified calibration protocols and recertified on scheduled timelines.
Performance Qualification is the final stage of equipment and process qualification, demonstrating how each system performs under actual production conditions.
Prospective Validation
Conducted for new products using the first three production batches to demonstrate process capability and consistency.
Retrospective Validation
Based on historical batch data demonstrating inter-batch consistency across a minimum of 20 commercial batches.
Concurrent Validation
Conducted during routine production to ensure ongoing process consistency and product quality.
Revalidation
Facilities, systems, and equipment are periodically evaluated to confirm they remain validated and compliant.
All instruments are calibrated as per defined schedules and SOPs. Calibration status, certificates, and next due dates are maintained with each instrument for complete traceability and regulatory compliance.
Any deviation found during calibration is immediately reported to the concerned department. The QA Department reviews and approves corrective actions with necessary recommendations to ensure uninterrupted compliance.
