Quality Control (QC) in Technology Transfer (TT)

Quality Control (QC) ensures that the transferred product or process consistently meets quality standards at the receiving site.

Key Aspects of Quality Control in TT:

1. Testing and Analysis: Routine testing of raw materials, intermediates, and finished products to verify potency, purity, dissolution rate, and other specifications.

2. Analytical Procedures: Standardized methods transferred from the sending site ensure consistent product testing at the receiving site.

3. Equipment Calibration: Instruments for QC testing must be accurately calibrated to produce reliable results.

4. Documentation: Detailed records of all tests, results, and deviations ensure transparency and traceability.

5. Handling Deviations: QC flags any non-conformances and initiates corrective actions to address them.

6. Sample Retention: Retaining samples allows for retrospective testing if quality concerns arise.

In TT, QC is essential to maintain product quality and ensure therapeutic efficacy, sustaining patient trust.