Quality Assurance
Tron Chemicals is committed to robust Quality Assurance systems that ensure every batch of pharmaceutical intermediates and specialty chemicals meets the highest global standards for safety, purity, and consistency.
Our Quality Commitment
Quality at Tron Chemicals is built on GMP-compliant systems, stringent documentation, and continuous process control across the entire product lifecycle. Each batch is manufactured under validated processes and released only after thorough quality review by an independent QA team, ensuring reliability for regulated and semi-regulated markets.
SOP-Driven Quality System
A comprehensive Standard Operating Procedures (SOP) framework forms the backbone of our Quality Assurance function, standardizing every critical activity from raw material receipt to finished goods dispatch. SOPs are aligned with WHO-GMP, ISO 9001:2015, and ICH Q7 expectations, ensuring consistency, traceability, and regulatory compliance in all operations.
Scope of QA SOPs
Our QA SOP portfolio covers key quality systems including document control, change control, deviation and OOS management, investigation and CAPA, batch review and release, product recall, market complaint handling, self-inspection, and internal audits. Additional SOPs govern vendor qualification, material sampling, process validation, cleaning validation, equipment qualification, environmental monitoring, data integrity, and training management for personnel at all levels.
SOP Structure and Control
Every SOP follows a standardized structure detailing purpose, scope, responsibilities, definitions, stepwise procedure, precautions, records, and revision history to ensure clarity and ease of implementation on the shop floor. All controlled documents are maintained through a digital document management system with version control and electronic approvals, ensuring only current, approved procedures are available for use.
Implementation, Training and Compliance
All employees receive role-based SOP training during induction, followed by periodic refreshers and assessments to verify understanding and operational competence. Training records, read-and-understand acknowledgements, and practical demonstrations are documented in an integrated system, ensuring that every activity is performed exactly as per approved procedures.
Deviation, Investigation and CAPA
Any deviation from SOPs, OOS/OOT results, or non-conformances triggers a structured investigation process led by QA, using root cause analysis tools and risk-based assessment. Corrective and Preventive Actions (CAPA) are defined, implemented, and verified for effectiveness, with trends monitored to drive continuous improvement and prevent recurrence.
Testing and Analytical Assurance
Quality is further reinforced through in-process and finished product testing based on validated analytical methods and pharmacopeial specifications wherever applicable. Robust sampling plans, method validation, instrument calibration, and controlled laboratory practices ensure accurate, reproducible results that support confident batch release decisions.
Continuous Improvement and Audits
Internal audits, customer audits, and regulatory inspections are used proactively to strengthen systems, close gaps, and update SOPs in line with evolving regulatory expectations and best practices. Review of quality metrics, deviation trends, CAPA effectiveness, and audit observations feeds into a structured Management Review framework, reinforcing Tron Chemicals’ culture of continuous improvement in Quality Assurance.