Qualification performance

In reality the OQ and PQ steps often blur. In order to establish that the instrument is functioning up to the requirements established by the laboratory, a series of test sanq)Ies are typically run in coiqunction with the standard/test cmnponents. However, a clear distinction occurs when an instrument is purchased for dedicated use in one analysis. In this case, the performance qualification will definitely extend 

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Quality systems require that facilities and equipment should be appropriate to the activities undertaken. Surfaces that are easy to clean and maintain in hygienic condition are a requirement in many situations. For example, cloth-backed chairs would not be acceptable in a laboratory that handled potentially biohazardous materials. Equipment should be checked at installation to demonstrate that it can perform its desired function. This is frequently done using an Installation Qualification, Operational Qualification and Performance Qualification (IQ /OQ/PQ) commissioning process. Routine maintenance and calibration programmes are then required to ensure that equipment continues to deliver the specified performance. 

The validation of ne v facilities, systems or equipment is usually accomplished using a four-stage process of design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). 

The validation process is subject to the following design specifications, user and performance requirements, preparation of a master plan/validation protocol (installation qualification, operational qualification, and performance qualification), execution of the protocol, preparation of a summary report, and on-going validation (and revalidation if changes are made). 

In a GLP-compliant laboratory, a data system must meet explicit requirements guaranteeing the validity, quality, and security of the collected data. Operational qualification (OQ) must be performed after any new devices are installed in the laboratory system and whenever service or repair are performed. The role of OQ is to demonstrate that the instrument functions according to the operational specifications in its current laboratory environment. If environmental conditions are highly variable, OQ should be checked at the extremes in addition to normal ambient conditions. Performance qualification (PQ) must be performed following any new installation and whenever the configuration of the system has been changed. PQ demonstrates that the instrument performs according to the specifications appropriate for its routine use. 

Defined maintenance procedures should include model or manufacturer specifics and a list of parts to be inspected, cleaned, lubricated, replaced, and/or calibrated. The replacement part numbers, cleaning solutions and lubricants, and calibration standards, along with the manufacturer s maintenance procedures to be followed, should be specified. Documentation is easily managed by creating a one-page checklist of instructions or performance parameters that can be checked off as each task is completed. Any issues or comments can be captured directly on the checklist. Provisions for failure or out-of-tolerance notification need to be clearly defined, as the equipment cannot be put back into service until the performance has been verified by conducting a performance qualification. 

Performance Qualification Phillip Townsend Associates Inc. (Houston, TX)... 

Performance qualification Demonstration that equipment/processes operate satisfactorily and consistently during the manufacture of actual product... 

As with any analytical instrumentation, processes that involve both operation qualification and performance qualification are implemented during manufacture of the instrumentation for /tPLC described in this chapter to ensure that the instrument will perform according to specifications. 

Performance qualification (PQ), in fine chemical production, 11 433 Performance testing of emulsion, 10 128 of paint, 18 71-73... 

Thus, while a well-maintained instrument is important for any chemical/physical measurement, in NIR, without a concurrent standard for comparison, it is critical that the instrument be continuously calibrated and maintained. Since the major manufacturers of equipment have worked with the pharmaceutical industry, this has been formalized into what is called IQ/OQ/PQ, or Instrument Qualification, Operational Qualification, and Performance Qualification. The first is routinely performed (at first) by the manufacturer in the lab/process location, the second in situ by the user with help from the manufacturer, and the third is product/use dependent. These formal tests apply to all instruments in any industry. 

For procedure or performance qualification, where the base metal will not withstand the 180 deg guided bend required by ASME BPV Code Section IX, a qualifying welded specimen is required to undergo the same degree of bending as the base metal, within 5 deg. 

For procedure or performance qualification of test specimens, testing shall be as required per ASME BPV Code Section IX. 

The construction organization has at least one currently employed welder or welding operator who, while in its employ, has satisfactorily passed a performance qualification test using the designated WPS. 

Thermocouples may be temporarily attached directly to pressure-containing parts using the capacitor discharge method of welding. WPS and performance qualification are required. After thermocouples are removed, the areas shall be examined by NDE visual and PT or MT for evidence of defects to be repaired. 

There are no calibrator tablets available for this apparatus. The approach to performance qualification would be as outlined previously, that is, to determine the critical parameters, which in this case will include dip rate and volume control. 

Instrument qualifications are the tests that are performed after the equipment is installed for use in a laboratory. Instrument qualifications include installation qualification, operational qualification, and performance qualification. These tests verify that the equipment is installed, operates, and performs according to the manufacturer s specifications. Each of these types of qualifications is defined in more detail in the following sections. 

The manufacturer often creates an instrument qualification plan and provides installation, operational, and performance qualifications to be executed in the customer s laboratory. The company using the equipment must determine if the manufacturer supplied instrument qualifications is comprehensive enough to be sure that the equipment is installed, operating, and performing correctly. If they feel it is not, they may choose to perform more tests themselves. 

Performance Qualification (PQ) This provides documented verification that the equipment and ancillary systems, when connected together, can perform effectively and reproducibly based on the approved process method and specifications. 

This chapter defines the terms, responsibilities, requirements and recommended procedures involved in pre-installation, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), which are all part of a typical HPLC system validation process. As the FDA does not publish a definitive reference or cookbook for these procedures, the suggestions herein are only recommendations. These have been successfully incorporated into formal standard operating procedures (SOPs) that have been implemented at a number of larger pharmaceutical establishments. As long as proper SOPs... 

Following the successful completion of the IQ and OQ protocols, one can then proceed to the post-installation tasks. These tasks include both performance qualification, as well as re-validation, re-calibration and maintenance. 

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