 Process qualification

Process qualification is a critical step in validating manufacturing processes, particularly in industries such as pharmaceuticals, biotechnology, and medical devices. It involves demonstrating that a specific process can consistently produce a product that meets predetermined specifications and quality standards under normal operating conditions. Here are the key components of process qualification: 1. **Installation Qualification (IQ)**: This phase verifies that the equipment and systems are installed correctly and according to the manufacturer's specifications. It often includes documentation of equipment specifications and installation procedures.