Certified Pharmaceutical GMP Professional Practice

In the qualification vs. validation comparison, what must happen first?

1. A system must be validated before qualification

2. A system must be qualified to operate in a validated process

3. Validation must be documented before any process can start

4. System designs must be reviewed before qualifications

The correct answer is: A system must be qualified to operate in a validated process

In the context of qualification and validation, qualification is a critical step that must occur before validation can be effectively carried out. Qualification establishes whether systems, equipment, and processes are able to consistently perform according to intended specifications and requirements. It is essentially about ensuring that the systems are set up and functioning correctly to support compliant operations. When a system is qualified, it is confirmed that it can operate within specific limits and that it will produce the desired results in a validated process. This is crucial because validation is the broader process which confirms that a system or process consistently produces a result that meets predetermined specifications and quality attributes. It relies on qualified systems and processes to achieve its goals. Thus, qualification must occur as an initial step to establish that conditions are suitable for the subsequent validation activities, ensuring adherence to regulatory standards and quality principles in pharmaceutical manufacturing. Validating a system without prior qualification may result in an unreliable process, potentially compromising product quality and safety.