Qualification & Validation

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Qualification & Validation

Qualification & Validation

Execution of URS/DQ/IQ/OQ protocols.
Process validation for consistent manufacturing output.
Cleaning validation to prevent cross-contamination.
Analytical method development, optimization, and validation.
Qualification of facilities, equipment, and utility systems.
Calibration programs and certification management.
Computerized System Validation (CSV) for GxP-critical applications.
Media fill studies for aseptic process verification.

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