Quality Management
Quality is never an accident; it is always the result of intelligent effort
At Purogene Labs Pvt. Ltd., quality is not just a regulatory requirement, it is a core value embedded in every stage of our operations.
We are committed to delivering high-purity chemical intermediates and specialty compounds with a focus on safety, consistency, and compliance.
Quality Policy
“We at Purogene Labs Private Limited, involved in bulk drug intermediate manufacturing, aim at achieving quality excellence and customer satisfaction through good manufacturing practices and strive for continual improvement.”
Chaitanya Gopineedi
(Managing Director)
Quality & Trust
Our Foundation
KEY ASPECTS
- Adherence to rigorous quality framework & assurance procedures
- Equipped with high-precision equipment for excellence
- Continuous upgradation of production & quality systems in product development cycles
Our Quality Philosophy
Brand “Purogene” continues to build on its legacy of trust in delivery; backed by a global-minded approach. We believe in a proactive, risk-based approach to quality that begins at the design stage and extends through manufacturing, testing, and product release. Our systems are aligned with ICH Q7, WHO-GMP, and global regulatory expectations.
Principle Elements of our Quality Management Systems at Purogene
Key Elements of Our Quality Management System
✅
Good Manufacturing Practices (GMP)
- Adherence to cGMP in all production processes.
- Detailed documentation, batch traceability, and change controls.
- Qualified equipment and validated processes.
🧪
Quality Control (QC)
- State-of-the-art analytical labs equipped with HPLC, GC, FTIR, UV, and titration systems.
- Raw material, in-process, and finished product testing using validated methods.
- Stability studies and impurity profiling as per regulatory needs.
🧾
Quality Assurance (QA)
- Review and release of products through QA-led batch record evaluations.
- Periodic self-inspections and internal audits.
- Vendor qualification and supplier audits.
🛡️
Data Integrity & Compliance
- ALCOA+ principles enforced across all quality documentation and digital records.
- Implementation of electronic data capture (EDC) systems.
- Training and awareness for 100% compliance.
🔁
Continuous Improvement
- Regular training and skill development for staff.
- CAPA (Corrective and Preventive Action) and root cause analysis processes.
- Trend analysis and risk-based quality review meetings.
📦
Documentation & Traceability
- Comprehensive document control system.
- SOPs, protocols, and records maintained in controlled formats.
- 100% traceability from raw materials to product delivery.
Regulatory Readiness
Purogene Labs is committed to meeting the highest regulatory standards required for domestic and international markets. Our documentation and practices are inspection-ready for USFDA, EDQM, and other global audits.
Comprehensive (QMS) Quality Management System & Compliance Framework
Vendor Approval and Evaluation
Qualification of Equipments
Validations
Trainings
Document Control and Records
Change Control Management
Deviations
CAPA Management
Out of Specification and Trend
Corrective Action and Preventive Action
Internal Audits/Self Inspections
Product Release
Product Quality Review
Pest Control Management
Stability Studies
Our Team
Our Quality Unit comprises experienced professionals in analytical chemistry, process validation, regulatory affairs, and GMP compliance. Their expertise ensures that every product meets the intended quality, safety, and efficacy.
Other Aspects Enabling Quality and Legacy of Trust
- Our manufacturing facilities adhere to rigorous quality framework and quality assurance procedures in line with global regulatory standards
- Our quality control laboratories equipped with high-precision equipment ensure excellence throughout the production process.
- Major thrust on production and quality systems upgradation ensure product quality and integrity
- Integrated risk-based quality management system principles in product development cycles