Operating parameters Operational qualification

Operational qualification establishes that an instrument will function according to its specification in the selected environment. The role of OQ can be considered as demonstrating that an instrument s key operating parameters are within specification and there are no unacceptable differences between the parameters... 

During operation qualification, all components of the instrument are tested individually along with integral parts of the overall instrumentation. In this section, results of some of the most common performance parameters are presented with a brief description of the methods used for evaluation. 

C. During operational qualification the analyst or vendor would assess if the equipment works as specified, generating appropriately documented data. The procedures will verify that the instrument s individual operational units are functioning within a given range or tolerance, reproducibly. For the dissolution apparatus, the water bath temperature and spindle assembly and shaft rpm speed would be obvious operational parameters. 

Performing an operational qualification ensures that the individual components of the instrument and the instrument as a whole are functioning correctly to certain defined specifications. The testing of individual instrument parameters and comparing the results to those specifications require the isolation of the parameters. Each identified parameter is related to a specific function within the instrument. Typical functions that should he subject to the qualification process and their associated parameters are described below. 

Performing an operational qualification procedure ensures that the specific parts of an instrument are functioning according to defined specifications for precision, linearity, and accuracy. For operational qualification, testing individual instrument parameters and comparing them to accepted values requires isolating each parameter. Each parameter is related to a specific CE function. Typical CE functions that are subjected to qualification and their associated parameters are shown in Figure 12.2. 

To ensure that specific criteria are set for all critical parameters, protocols should be developed for installation qualification (IQ), operational qualification (OQ), and performance qualifications (PQ). Again, they are generally only prepared for any systems, processes, or equipment that are defined as critical. More important than how these concepts are prepared is that the application must be based on a sound scientific approach. 

USP General Chapter <711> Dissolution,5 describes the basic operation of these apparatuses in detail. The Apparatus section describes the basic parameters or operational qualifications and usually provides tolerances to these operational variables. Operational variables for the basket are the following ... 

The United States Pharmacopoeia (U.S.P.) [5] in a chapter on validation of compendial methods, defines analytical performance parameters (accuracy, precision, specificity, limit of detection, limit of quantitation, linearity and range, ruggedness, and robustness) that are to be used for validating analytical methods. A proposed United States Pharmacopeia (U.S.P.) general chapter on near-infrared spectrophotometry [6] addresses the suitability of instrumentation for use in a particular method through a discussion of operational qualifications and performance verifications. 

The humidity of the room where the product is exposed should be considered a critical parameter when a humidity-sensitive product is being manufactured. The humidity sensors and the humidity monitoring system should, therefore, be qualified. The heat transfer system, chemical drier or steam humidifier, which is prodiicing the humidity controlled air, is further removed from the product and may not require operational qualification. 

A room cleanliness classification is a critical parameter and, therefore, the room air change rates and HEPA filters should be critical parameters and require qualification. Items such as the fan generating the airflow and the primary and secondaiy filters are non-critical parameters, and may not require operational qualification. 

NONMEM For the operational qualification, a careful review of the parameters discussed in Section 2.9 of the NONMEM Users Guide—Part III (17) should be performed. These values should be identified and set during the IQ and tested properly during the QQ. The specific examples provided for NQNMEM s PREDPP, NM-TRAN, and associated library subroutines are highly recommended as a starting point for the QQ. The Phenobarbital and Theophylline data files provided with the software (18) offer even more extensive testing appropriate (with modification) for a PQ. The output is well documented and individuals may seek to modify or parameterize the examples for their needs. 

Operational qualification—Confirmation that the equipment performs as intended entails evaluation of performance capabilities. It incorporates measurements of speeds, pressures, and other parameters. 

To ensure that equipment is fit for its intended purpose, there is a series of qualifying steps that the analyst or vendor should apply to analytical instrumentation (3,4). Equipment can be evaluated through a series of tests or procedures designed to determine if the system meets an established set of specifications governing the accepted operating parameters. The successful completion of such tests justifies that the system operates and performs as expected. There are four components of instrument qualification design, installation, operational, and performance. 

The performance qualification is a documented program to demonstrate that an operation, when carried out within defined parameters, will consistently perform its intended function to meet predetermined acceptance criteria. 

List of operation parameters (cycle events/times, TC distribution probes, biological indicator test, installation qualification review, sterilizer SOP review) acceptable limits, and study results... 

The qualification studies conducted indicated that the GMP steam sterilizer (autoclave) performance is satisfactory and in accordance with the operational parameters defined previously. 

Process demonstration formerly called process qualification, represents the actual studies or trials conducted to show that all systems, subsystems, or unit operations of a manufacturing process perform as intended that all critical process parameters operate within their assigned control limits and that such studies and trials, which form the basis of process capability design and testing, are verifiable and certifiable through appropriate documentation. 

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