Qualification definition

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. 

It is idle to pretend that a definite comparison of optical (ultraviolet, visible, and infrared) emission spectrography with x-ray emission spectrography can be made at this time. We give in Table 8-4, with little qualification and no defense, what we consider to be a fair comparison for a laboratory called upon to determine a large number of elements under a variety of conditions not necessarily known in advance. 

When equipment is physically moved to another location. Definition of another location must be made within the company s SOP. Manufacturer recommends a re-qualification if equipment is lifted during the move or if the environmental conditions are different in the new location. 

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. 

However, various countries use different definitions of chemical waste and there are often several inconsistencies in the definitions. Usually, the definiUon involves qualification of whether or not the material is hazardous. For example, in some counties, a hazardous waste is any material that is especially hazardous to human health, air, or water, or which is explosive, flammable, or may cause disease. Poisonous waste is material that is poisonous, noxious, or polluting and whose presence on the land is liable to give rise to an environmental hazard. But in more general terms (in any country), hazardous waste is waste material that is unsuitable for treatment or disposal in municipal treatment systems, incinerators, or landfills and which therefore requires special treatment. 

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... 

Instrument e.g., cooling system, capillary types and lengths possible, type of detectors, instrument sensitivity, software and integration functions, maintenance status of instrument and qualification status, definition of instrument cleaning procedures... 

While it is clear that some people will not accept a definition of safety that is relative, it appears that most people feel safe when they are convinced that risks to their well-being are sufficiently low, even if not completely absent. (There are some dramatic and important qualifications on this conclusion, as we shall see in the later section concerning people s perceptions of risk. While for the most part people accept that the condition of safety is not equivalent to the condition of being completely risk-free, most people do not perceive risk as simply a matter of probability, as do the experts. This intriguing and well-documented fact complicates greatly the public dialogue on matters of risk.)... 

System qualification is a process that ensures that an analyzer system is installed and operated according to requirements that are aligned with the intended use of the system. The commonly used approach in the pharmaceutical industry is the system life cycle or SLC process. In the SLC approach, the definition of intended use, design, configuration, installation and operation is linked and documented over the lifetime of a system. 

In order to present clear concepts it is necessary that idealized definitions be adopted but it is reeognized that the realities of polymer science must be faced. Deviations from ideality arise with polymers at both molecular and bulk levels in ways that have no parallel with the ordinary small molecules of organic or inorganic chemistry. Although such deviations are not explicitly taken into account in the definitions below, the terms recommended can usefully be applied to the predominant structural features of real polymer molecules, if necessary with self-explanatory, if imprecise, qualifications such as essentially. , almost completely. , or highly. . Although such expressions lack the rigour beloved by the purist, every experienced polymer scientist knows that communication in this discipline is impossible without them. 

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. 

Reporting the initial setpoints enables definition of the characteristics of the system as it is during qualification and will evidence any subsequent modifications of the setpoints. 

The parallel point holds for inability. As Hampshire (1965) says "When we definitely, and without qualification or conflict, want to do something at a particular moment, sincerely make the attempt in normal conditions, and yet fail, we know as surely as we can ever know that at that moment we... 

The "important qualification" is that a mere commonality of behavior, norms, values, beliefs, or concepts in a certain group does not by itself constitute a pattern of culture. In addition to these shared characteristics I require, as Charles Taylor (1971) says in a different context, that the sharing itself be shared. I require, that is, that the members of the group are aware of the fact that others hold similar norms, values or beliefs or that they can be expected to behave in a similar manner. Whether or not one also makes it part of the definition that each member is aware that others are aware of this fact, and so on, these higher-order beliefs can usually be assumed to obtain. 

The Laboratory of the Government Chemist (LGC) and Eurachem-UK has developed a guidance document with definitions and step-by-step instructions for equipment qualification [2]. 

Qualification of equipment and validation of computer systems are not one-time events. They start with the definition of the product or project and setting user requirement specifications and cover the vendor selection process, installation, initial operation, ongoing use, and change control. 

The most important factors for the entire process of equipment qualification and computer system validation in analytical laboratories are proper planning, execution of qualification according to the plan, and documentation of the results. The process should start with the definition of the analytical technique and the development of user requirement and functional specifications. For computer systems, a formal vendor assessment should be made. This can be done through checklists and vendor documentation with internal and/or external references. For very complex systems, it should go through a vendor audit. 

CH SC Section 25123.3 Definition of "storage facility", including quality and time limits for qualification as a storage facility. 

It appears that despite the lack of reliability of acidity determination of solid acids by spectroscopic means and in the absence of knowledge of the nature of the initial step in alkane activation by solid acids the qualification of superacid solids has been and continues to be used, despite the absence of a clear definition of solid superacidity. 

This section presents first the formulation and basic definitions of constrained nonlinear optimization problems and introduces the Lagrange function and the Lagrange multipliers along with their interpretation. Subsequently, the Fritz John first-order necessary optimality conditions are discussed as well as the need for first-order constraint qualifications. Finally, the necessary, sufficient Karush-Kuhn-Dicker conditions are introduced along with the saddle point necessary and sufficient optimality conditions. 

Initial media fill qualification typically involves a minimum of three consecutive, separate, and successful media fills. The definition of successful has evolved from allowing one contaminated unit out of 1000 containers to having zero contaminated units. 

Since the definition of validation seems to vary from nation to nation, we will include all activities from design to final product, as well as individual validation, such as process validation [2] (product qualification in ISO). 

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. 

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