🔄 Change Control at Talwar Pharma

At Talwar Pharma, the Change Control System is a structured approach used to manage any planned changes in processes, equipment, materials, or documentation that could impact product quality or compliance.

All proposed changes—whether minor or major—must go through a formal review and approval process conducted by the Quality Assurance (QA) team and relevant department heads. This includes:

• Evaluation of impact on product quality, safety, and efficacy

• Review of regulatory and GMP compliance

• Risk assessment and documentation

• Implementation planning and employee training

Each change request is documented through a Change Control Form (CCF) with details like purpose, scope, impact analysis, and proposed actions. Upon approval, the change is implemented under controlled conditions with proper tracking and validation (if required).

Talwar Pharma’s robust change control ensures that continuous improvement never compromises product quality or patient safety, and that all modifications are fully traceable and compliant.