Quality built into the pharmaceutical lifecycle
Novagene's quality systems bring together documented procedures, process controls, dedicated quality control departments and systematic oversight. The plant includes three separate QC departments supporting the Cephalosporin, Penicillin and Carbapenem blocks.
Quality by principle. Precision by practice.
Combining disciplined processes, scientific evaluation and quality oversight to support consistency at every stage.
Documented, controlled, evaluated
Quality assurance
Documented procedures, process controls, controlled documentation and systematic oversight support disciplined pharmaceutical operations.
Quality control
Three dedicated QC departments support the analysis and evaluation of raw materials, in-process materials and finished products.
Analytical capability
QC infrastructure includes 03 HPLCs, FTIR, Atomic Absorption, UV, Dissolution Apparatus, Stability Chambers, TOC and KF, along with other supporting equipment.
Stability
1000-litre stability chambers support ongoing and accelerated stability studies with 24/7 data loggers.
Precision in every test, control in every record
Precision in every test
The QC infrastructure includes modern analytical equipment supporting pharmaceutical testing and evaluation, including 03 HPLCs, FTIR, Atomic Absorption, UV, Dissolution Apparatus, Stability Chambers, TOC and KF.
Stability and ongoing evaluation
1000-litre stability chambers are provided for ongoing and accelerated stability studies, supported by 24/7 data loggers to maintain continuous monitoring.
Good documentation practices
A dedicated D&DC section controls documentation and records. The system includes a master list of SOPs, machine and equipment code lists, controlled balance records and calibration, QA-controlled filter listings, periodic document review and controlled archiving of BMRs and analytical documents.
Traceability and data integrity
Printable weighing balances, printable analytical balances, dispensing SOPs, controlled documentation and record systems, SAP ERP implementation and data-integrity practices support traceability and operational control.
Packaging and serialization
Three dedicated printing lines are equipped with QR code and serialization facilities on finished packs. Production and packing systems include PLC-operated equipment and controlled batch-record practices.
Designed to PIC/S standards
The plant is designed according to PIC/S standards and targets PIC/S GMP compliance and zero contamination. Novagene's operations emphasize cGMP-focused quality practices, dedicated segregation and controlled manufacturing environments.
Quality systems you can audit
For technical documentation, audit requests or partnership discussions, our team is ready to assist.