How an equipment is qualified in pharma company?

Answer 1

In a pharmaceutical company, equipment qualification is a systematic process that ensures equipment operates consistently and within specified parameters. This typically involves three phases: Installation Qualification (IQ), which verifies that the equipment is installed correctly; Operational Qualification (OQ), which confirms that it operates as intended under defined conditions; and Performance Qualification (PQ), which demonstrates that it consistently performs effectively in real-world conditions. Documentation and adherence to regulatory standards, such as Good Manufacturing Practices (GMP), are critical throughout the qualification process to ensure compliance and product quality.