At CellArtgen Lab Pvt. Ltd., our Quality Control system is comprehensive, fully controlled, and designed to eliminate any ambiguity or uncertainty in our manufacturing processes. Every product manufactured at our facility is subject to rigorous quality checks at every stage.
We maintain all documentation as per the requirements of our Quality Management System, ensuring that every product conforms to predefined specifications. Key documents include the Validation Master Plan, Quality Manual, Training Manual, Master Formulas, Standard Operating Procedures, and all supporting records.
“Control is not restriction — it is the highest form of precision.”
Every product at CellArtgen Lab has a dedicated Master Formula containing complete product information — including composition, packing details, processing instructions, manufacturing steps, in-process checks, and testing requirements. All Master Formulas are approved by the Head of Quality Assurance.
Documentation is systematically categorized into Product/Process Specifications, Raw Material Specifications, Packaging Component Specifications, Batch Manufacturing Records, Analytical Methods, and Validation Documents — ensuring complete traceability at every step.
Our Quality System Manual comprehensively covers all critical areas of pharmaceutical manufacturing and quality management:
- Premises & Facility Management
- Personnel Hygiene & Safety
- Cleaning & Sanitation Protocols
- Good Laboratory Practices
- Calibration & Instrument Management
- Contamination Control
- Validation Policy & Master Plan
- Water for Pharmaceutical Use
- Warehousing & Storage
- Laboratory Controls
- Packaging & Labelling
- Stability Studies
- Vendor Approval System
- Change Control & Deviations
- Annual Product Review
- Product Recall & Market Complaints
- Self-Inspection Program
- Release of Finished Goods
Our Validation Master Plan covers all aspects of qualification of facilities, equipment, processes, calibration, and revalidation. It is reviewed and revised every two years or whenever required. All documents are controlled by the QA Department with regulated distribution as per defined SOPs.
All personnel working at CellArtgen Lab whose roles are directly or indirectly associated with product quality receive continuous cGMP training. Comprehensive training programs are developed by the Head QA in collaboration with the Head of Production and Head HR — covering employees at every level of the organization.
🎓 Induction Training
🔬 cGMP Training
💼 On Job Training
🔄 Refresher Training
🌍 External Training
📋 Behavioral Training
🎯 Needs Identification
📝 Re-training
