Quality Assurance & Instrumentation
34 precision laboratory testing instruments, validated environmental controls, and 9 QA subsystems guaranteeing WHO-GMP product safety.
9-Pillar Quality Assurance Control Architecture
Integrated quality management procedures enforced across raw materials, manufacturing operations, testing, and distribution.
Change Control System
Documented evaluation, review, and approval process for any changes affecting facility, utilities, equipment, or SOP documentation.
Deviation Management
Systematic investigation, evaluation, and closure of any departures from approved manufacturing procedures or specification limits.
CAPA Implementation
Corrective & Preventive Action methodology identifying root causes of non-conformances and preventing recurring quality issues.
Quality Risk Assessment
Proactive risk-based evaluation quantifying risks to product quality and patient therapeutic safety.
Product Quality Review (PQR)
Periodic review of batch manufacturing and laboratory data to verify process capability and identify optimization trends.
Self-Inspection Audits
Internal GMP audits performed periodically by QA auditors to ensure continuous Schedule M compliance.
Market Complaints Handling
Documented procedure for rapid receipt, laboratory evaluation, root-cause investigation, and closure of customer complaints.
Product Recall System
Rapid retrieval protocol enabling immediate recall of products from market distribution in case of quality safety concerns.
Vendor Qualification
Evaluation and approval system for suppliers of raw materials, APIs, and primary packaging components based on quality audits.