1. To ensure all types of validation protocols are prepared, review of validation protocol and coordination for its execution and compliance, report review for compliance.
2. Responsible for effective implementation of cleaning procedure validation in manufacturing plants and coordination for its execution, its protocol and report for compliance.
3. Review of qualification protocols and ensure that qualification is done within stipulated time by coordination.Review of reports for compliance.
4. Monitoring, coordination and review compliance of equipment qualification and validations as per the approved protocols and procedures.
5. Responsible for ensure and coordination for the compliance of Validation Master Plan.
6. Responsible for monitoring of cross contamination program and policy for its effective implementation.
7. Responsible for monitoring of Periodic Validation/ Re-qualification Performance Verification program of sterile Manufacturing Facility as per Validation Master Plan and its report review for compliance.
8. Responsible for monitoring and compliance of Process Simulation studies
9. Responsible for transit studies monitoring and compliance for sterile Penem Products.