What is Performance Qualification (PQ)?
In industries that are highly regulated, like pharmaceuticals and medical device manufacturing, validation is everything. It’s how companies ensure their products are safe and effective, and it’s where the term performance qualification meaning comes into play.
Performance Qualification (PQ) is a key step in the validation process. It provides documented evidence that a process or piece of equipment consistently performs to a pre-defined standard under normal operating conditions. Without it, companies face recalls, regulatory problems, and damage to their reputation.
PQ is different from installation qualification (IQ) and operational qualification (OQ). IQ confirms that equipment is properly installed, and OQ confirms that it operates within specified ranges. PQ, however, confirms sustained performance under real-world production conditions, verifying that the equipment, personnel, materials, and environment all work together to consistently produce the desired result.
In this article, we’ll explore the meaning of PQ in detail, its role in the validation lifecycle, best practices for execution, and how to overcome common challenges. We’ll also look at the relationship between PQ and Quality by Design (QbD), and how to find the right qualification and validation services. By understanding these key aspects, companies can improve their PQ processes and stay compliant with regulations.
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