Our Quality Vision
Tron Chemicals maintains a robust, GMP-compliant Quality Control (QC) system to ensure every batch of pharmaceutical intermediates, APIs, nutraceuticals, and specialty chemicals consistently meets global regulatory and customer standards for purity, safety, and performance. Quality control is integrated across the entire product lifecycle—from raw material qualification to in-process checks and final batch release—supported by detailed SOPs, advanced analytics, and continuous improvement practices.
Our Quality Control Philosophy
Quality at Tron Chemicals is built on scientific rigor, regulatory compliance, and data-driven decision-making. QC and QA functions are clearly defined yet closely integrated, ensuring that product quality is designed into processes and verified at every critical step. This holistic approach supports reliable, on-spec supplies for regulated markets.
Raw Material and In-Process Control
All incoming raw materials undergo identity verification, purity testing (HPLC/GC), and contamination screening before use in manufacturing. During production, critical process parameters such as temperature, pH, viscosity, and reaction time are continuously monitored using in-process controls and statistical process control (SPC) tools to detect and correct deviations in real time. This tight control of intermediates and key starting materials helps maintain impurity levels within stringent customer and pharmacopeial specifications.
Analytical Capabilities and Testing
Tron Chemicals’ QC laboratories are equipped with HPLC, GC, GC-MS, NMR, IR, and wet chemistry capabilities to provide comprehensive testing for assay, impurities, residual solvents, and stability. Analytical methods are developed and validated as per ICH guidelines, ensuring accurate, precise, and robust results with impurity detection limits below 0.1% where required. Each batch is released only after independent QC and QA review, supported by detailed Certificates of Analysis (COAs) and spectral data (NMR, IR) on request.
Compliance, SOPs, and Documentation
The QC function operates under a structured SOP framework that covers sample management, testing procedures, instrument calibration, data integrity, OOS/OOT handling, and change control. SOPs are reviewed periodically and updated based on audit findings, regulatory changes, and risk assessments, aligning with WHO, ICH, and PIC/S GMP expectations. Electronic documentation and controlled templates ensure traceable, audit-ready records for all QC activities.
Deviation, OOS, and CAPA Management
Any out-of-specification (OOS) or out-of-trend (OOT) result triggers a structured investigation process using 8D and root cause analysis tools, ensuring issues are fully understood and addressed before batch disposition. Corrective and preventive actions (CAPA) are documented, implemented, and verified for effectiveness, feeding back into process optimization and SOP refinement. This systematic approach has enabled Tron Chemicals to maintain a strong compliance record with zero critical regulatory observations.
Continuous Improvement and Training
Tron Chemicals applies Six Sigma and PDCA methodologies to quality metrics such as deviations, rejects, and rework, driving year-on-year reductions in defects and process variability. QC and QA personnel receive regular training—often exceeding 40 hours annually—on cGMP updates, data integrity, and new analytical techniques to keep competencies current. Combined with periodic internal and customer audits, this culture of continuous improvement ensures that Tron Chemicals remains a trusted partner for high-quality pharmaceutical intermediates and specialty chemicals.