Process Validation
Statistical Techniques for PROCESS VALIDATION
Orfil QIS offers a vast experience conducting Process Validations providing support to perform the three validation phases:
- Installation qualification (IQ) to demonstrate that the equipment is installed properly.
- Operational Qualification (OQ), which includes characterization to identify the key parameters and operating windows.
- Performance Qualification (PQ), to demonstrate process consistency under production conditions.
We use procedures with valid statistical techniques in compliance with FDA and ISO regulations.
Software applications used: MINITAB, VTA (variation transmission analysis) and Acceptance Sampling.
We will complete the Validation Package together for your own satisfaction.
Minimum Conformance Rates for the Conforming OQ and PQ studies
| Product Risk Level | PQ | OQ |
| High | 99% | 95% |
| Moderate | 97% | 90% |
| Low | 90% | 80% |
Note: These levels are generally consistent with values used in the industry. Dr. Wayne Taylor