Performance Qualification definition

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... 

Operation, maintenance and calibration procedures Before commencing performance qualification, authorized procedures must be in place for routine use of the facility or operation, training of operators, routine calibration and maintenance, notification and recording of problems, and for the definition of actions to be taken in the event of breakdown. 

Equipment qualification typically entails installation qualification (IQ), to demonstrate that the equipment is indeed what was specified operational qualification (OQ), to demonstrate that the equipment performs acceptably over its design range and performance qualification (PQ), which demonstrates that the equipment renders consistent performance. No time will be spent providing formal definitions for these terms. 

Definition of Process and Systems Process R D - Installation Qualification Operational Qualification Prospective Performance Qualification i IMb Commercial Production... 

Equipment qualification—Definition of the equipment, system, and/or environment used for the process. These data are used to gather a baseline of the installation/operational condition of the system at the time when the performance qualification (PQ) of the system is performed. This baseline information is used to evaluate changes to the system performance over time. Intentional changes from these initial conditions must be considered and evaluated to establish that the system s performance is unaffected by the change. Unintentional changes in the form of a component or equipment malfunction or failure can be easily rectified using the available baseline data as a basis for proper performance. 

Implementation of the software design commences once the design is finalized. Sandpit (prototyping of application functionality) and development facilities are required to support system definition and development. A validation environment to perform qualification testing and a live environment completes the system development and operational architecture. 

As with most pieces of equipment used in a GMP operation, stability chambers must go through a qualification process prior to use. This process traditionally includes three stages identified as the Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). At each stage a qualification protocol is written, approved, and executed. After successful execution a qualification report is written and approved. Upon approval, the next qualification stage is performed. Many components of equipment qualification are common to all pieces of equipment. A brief definition of each stage of qualification will be provided along with what might be included that is unique to stability chambers. 

The problem lies in that the specification of the system is not fully known or defined until the CRP is all but complete, and this is typically immediately prior to go live. On a pressured-driven, business-critical project, where is the opportunity to produce an approved System Definition, Installa-tion/Operational/Performance Qualification (IQ/OQ/PQ) test protocols when the information comes so late in the day ... 

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... 

The degree of lot-to-lot reproducibility you require from a column is ultimately a function of the needs of a particular assay, which makes it impossible to state definite limits that will be appropriate in every case. Whatever the level of variation, it is important that it be documented. As new lots of media are brought into use over the course of years, their performance vs. the established reference should be included in a master database begun with the original qualification testing. Among other factors, this will allow you to track the column manufacturer s performance over time and possibly detect trends that could affect your assay performance — before a problem occurs. 

Most firms today start by qualifying each subsystem. To qualify, of course, means to establish convincing evidence that something happens as intended, which matches the validation definition (in more explicit terms, however). Installation qualification may be defined as documented verification that all key aspects of the installation adhere to manufacturer s recommendations, appropriate codes, and approved design intentions. Operational qualification is documented verification that a system or subsystem performs as intended throughout all specified operating ranges. 

The chemist reviews results of each analysis and determines whether data qualification is needed. Typical deficiencies that turn definitive data points into estimated ones include insufficient surrogate standard recoveries the absence of second column confirmation and the quantitation performed outside the calibration curve. The chemist may even reject the data based on low surrogate standard recoveries. Example 5.6 shows how surrogate standard recoveries may affect the validity of analytical results. 

The Infrared Handbook (The Environmental Research Institute of Michigan, 1985) provides an extensive table of terms and definitions (Sec. 19.1.2) and a list of specimen specifications (Sec. 19.4.1). The section of the handbook covering IR imaging systems does not, however, deal with the imager as a quantitative measurement instrument, so the performance parameters related with temperature measurement must be added. From the user s point of view, some simplifications can be made which result in some acceptable approximations. Bearing these qualifications in mind, the following definitions of the key performance parameters of IR quantitative cameras are offered ... 

On the basis of the objectives, functions and responsibilities of the operating organization discussed in Section 3, a proper definition and detailed analysis of tasks and activities to be performed should be made the appropriate staffing and qualification requirements at the different levels in the organization should be determined, and the selection, training and retraining requirements should be specified. 

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