Quality Assurance

We uphold rigorous quality standards through a comprehensive set of procedures designed to ensure product integrity and regulatory compliance. Our key operational areas include:

• Batch Release Procedures: Meticulous protocols for ensuring every product batch meets stringent quality specifications before release.
• Record Retention & Documentation Maintenance: Strict adherence to guidelines for archiving and managing all critical records and documentation, ensuring data integrity and traceability.
• Internal Audits: Regular internal assessments to verify compliance with established procedures and identify areas for continuous improvement.
• Change Control & Deviations Management: Robust systems for managing and documenting all changes to processes, materials, or equipment, along with thorough investigation and resolution of any deviations.
• Validations Review and Approvals: Comprehensive review and approval processes for all validation activities, confirming that systems, processes, and equipment consistently produce expected results.
• Vendor Qualifications: A thorough program for evaluating and qualifying suppliers to ensure the quality and reliability of all incoming materials and services.
• Risk Assessment: Proactive identification and mitigation of potential risks across all operations to safeguard product quality and patient safety.
• Complaints Handling: Efficient and systematic processes for receiving, investigating, and resolving customer complaints.
• Manufacturing Investigations: Detailed investigations into any issues or discrepancies arising during the manufacturing process to determine root causes and implement corrective actions.
• Audit Preparation & Hosting: Expertise in preparing for and hosting audits from regulatory agencies and customers, demonstrating our commitment to transparency and compliance.
• cGMP Training: Continuous training programs to ensure all personnel are well-versed in current Good Manufacturing Practices (cGMP) and regulatory requirements.
• Preparation and Approval of Annual Product Quality Reviews (APQRs): Regular compilation and approval of APQRs to monitor and assess product quality trends over time.
• Regulatory Agency and Customer Audits: Active participation and successful management of audits from regulatory bodies and customers, affirming our adherence to global standards.