Before a system, instrument or equipment is ready for use, its performance needs to be verified thoroughly, throughout the range of parameters that it might operate in.
This is often achieved with performance qualification (also known as P1Q). The “1” in P1Q is to avoid confusing it with process qualification (PQ), which is used in process validation to verify the capabilities of processes.
It is usually performed after all other qualifications like DQ IQ OQ PQ. The exact sequence followed can vary, but P1Q is typically performed after successful installation qualification. Also, if operational qualification (OQ) is needed, it is recommended to complete it before commencing P1Q.
• P1Q involves targeted testing to verify that the equipment can deliver the performance criteria specified in the user requirement specification.
• It is an included requirement of the cGMP guidelines for health and safety, as well as other guidance documents.
• Verification, calibration and validation may be required, for is also required to confirm the requirements of health and safety rules and other guidance documents
Scope of Performance Qualification.
According to regulatory documents, like FDA guidelines, the scope of P1Q is somewhat limited. While equipment validation tests the ability individually for each piece of equipment, P1Q verifies the performance of equipment, systems and facilities as a whole.
It represents the final qualification, including any requalification of the system and equipment that you use in your business. The procedure involves a range of tests that are designed to simulate the entire process running in real-world scenarios.
Typically, the scope of P1q extends to include the following scenarios:
• New systems being delivered and operated for the first time
• Existing systems in use (as part of a regular maintenance schedule)
• Systems that have been modified to any degree
• Equipment or systems which have been used more than they normally would be
• Creating a checklist for troubleshooting or analyzing deterioration in efficiency or performance
• After a system has been expanded in order to increase its capacity
Frequency of Performing Performance Qualification
The objective of P1Q is to provide quality assurance that the system is capable of being subsequently validated. GMP and other such guidelines might not specify the frequency of performing P1Q, so the schedule or frequency you choose depends on a lot of factors.
Most organizations prefer to bring in some external equipment validation services for assistance with this process. They can help create a checklist of procedures and recommend a frequency that you should follow for P1Q.
This will typically be one or more of the following:
• Each time the equipment or system is used
• Before, after, or even during, a series of operations
• Other periodic schedule, or as needed
Which Tests are Performed in Performance Qualification?
New equipment starts with design qualification (DQ) and typically, P1Q is one of the final steps in the process. It encompasses a wide range of tests that can be clubbed on the basis of the procedure being qualified:
• Creating documentation for all testing procedures and performance criteria
• Critical parameters of system performance and predefined specifications of capability or standards
• Defining the protocol for corrective actions when the system is unable to meet the acceptable criteria for performance
• When you don't have enough knowledge to take informed decisions about certain requirements, like:
- The correct performance measurements
- Indicators for checking if measurements are within acceptable ranges
- The measurements used are incorrect
- Environmental conditions and their effects on measurements
- Protocol for corrective actions when the system is unable to meet the acceptable criteria for performance