Certified Pharmaceutical GMP Professional Practice

What is the purpose of Performance Qualification (PQ)?

1. To meet industry regulations

2. To ensure premises and equipment perform consistently as designed

3. To verify the effectiveness of cleaning procedures

4. To document the validation processes of equipment

The correct answer is: To ensure premises and equipment perform consistently as designed

The purpose of Performance Qualification (PQ) is to ensure that the premises and equipment perform consistently as designed under actual operating conditions. PQ is a critical phase in the validation process, focusing on confirming that the equipment operates within specified parameters and meets the intended performance criteria when it is used in real manufacturing processes. During PQ, the performance of the system or equipment is tested under normal operating conditions to validate its functionality. This step is essential for ensuring that products are manufactured safely and effectively, ultimately aligning with good manufacturing practices (GMP). Successful PQ confirms that equipment and processes will consistently function as intended in a way that is reproducible and reliable, which is vital for patient safety and regulatory compliance. While meeting industry regulations, verifying the effectiveness of cleaning procedures, and documenting validation processes are important components of the overall quality assurance strategy in pharmaceuticals, they do not capture the explicit focus of PQ, which is centered on the actual performance and functionality of the equipment in its operational context.