Quality attributes definition

Although this definition refers specifically to a process, it can also be easily applied to automated systems and software. One could read this as Establishing documented evidence which provides a high degree of assurance that a specific automated system and/or software product will consistently operate and perform to its pre-determined specifications and quality attributes . 

The preparation of any pharmaceutical product requires controls over the production operations to assure the end result is a product that meets the required quality attributes. The methods utilized for this control are supported by formalized validation studies in which proof of consistency is demonstrated by appropriately designed experiments. The definition of appropriate operating parameters is the primary objective of the development activities and is further confirmed during scale-up to commercial operations. The validation supports that the routine controls applied to the process are appropriate to assure product quality [36], This is typically accomplished in formalized validation activities in which expanded sampling/testing of the product materials is performed to substantiate their uniformity and suitability for use [30],... 

Definition of the API in terms of its critical quality attributes. Among the attributes that should be considered are chemical purity qualitative and quantitative impurity profiles physical characteristics such as particle size, bulk and tap density polymorphic forms moisture and solvent content homogeneity and microbial quality (if the product is susceptible to microbial contamination). 

An input parameter value is directly related to an output parameter or quality attribute specifically, the output parameter of one unit operation often is the input parameter for the subsequent unit operation [32]. Equivalently stated, critical Ys (outputs or responses) from one stage often are inputs for next the stage [37]. Input parameters are assessed as to whether they significantly impact critical output parameters (e.g., product safety, identity, and efficacy), although the definition of significant varies among applications [32]. As all product quality attributes are not routinely measured during process development, some output variables are selected... 

As introduced in Sect. 8.2.1, the roadmap of any QbD approach starts with the Target Product Proflle (TPP) definition this summary of drug characteristics (e.g., pharmacokinetic properties and stability) will serve as the basis for a set of performance parameters (e.g., immediate release drug 80 % in < 30 min, 36-month shelf life at room temperature, respectively) that, in turn, will be linked to a set of Critical Quality Attributes (CQAs e.g., shelf life will depend on the amount of residual solvents due to its impact on chemical stability release profile will depend on particle size for some drugs due to its impact on dissolution). 

Usability is defined as one of the main SW product and system quality attributes in the international standard ISO 9126. Usability refers to the capability of the product to be understood by, learned, used by and attractive to the user, when used under specified conditions [18]. Another widely referred to definition of usability is in standard ISO 9241-11, where usability is defined as the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a specified context of use (see e.g. in [17]). 

Molders Division of The Society of Plastics Industry (SPI) has developed cosmetic specifications of injection-molded parts. The purpose of this standard is to provide quantitative definitions and recommended methods of inspection and measurement of the cosmetic quality attributes in the absence of customer provided specifications. The specification addresses the cosmetic quality of molded plastic parts and related post-molding activities. Figure 16-12h shows one of the cosmetic specifications. 

API method development effort during dmg discovery is limited. In phase I, all impurities must be separated from a major peak to ensure peak purity. In phase n, a synthetic route needs to be selected and optimized. The method needs to be challenged when the route or process is changed. In phase III, the route is selected and the process is finalized. Critical Quality Attribute (CQA) impurities are defined and their references are typically prepared for method development. Method robustness and ruggedness must be demonstrated, and relative response factors of all impurities CQAs are determined before regulatory filing such as NDA and MAA. The validated definitive methods are transferred to manufacturing sites. 

In a general way, validation is the documentary evidence process that an analytic method will lead, with a high degree of security, to obtain precise and accurate results, within specifications and quality attributes previously established. Validation data must be submitted for all analytes included in the residue definition for all representative sample matrices to be analyzed at adequate concentration levels. The five fundamental parameters required for the European Commission for analytic validations of methods used with pesticides are as follows linearity and range, accuracy, precision, selectivity, and LOD and LOQ. These are collected in the SANCO guidelines together with their well-detailed requirements [43 5]. 

What do we mean when we speak of an inherently safer chemical process Inherent has been defined as existing in something as a permanent and inseparable element, quality, or attribute (American College Dictionary, 1967). A chemical manufacturing process is inherently safer if it reduces or eliminates the hazards associated with materials and operations used in the process, and this reduction or elimination is permanent and inseparable. To appreciate this definition fully, it is essential to understand the precise meaning of the word hazard. A hazard is defined as a physical or chemical characteristic that has the potential for causing harm to people, the environment, or property (adapted from CCPS, 1992). The key to this definition is that the hazard is intrinsic to the material, or to its conditions of storage or use. Some specific examples of hazards include ... 

The terms and definitions taken from ISO 2859-1 1999 Sampling procedures for inspection by attributes Part 1 Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection, Table 1, a portion of Table 2-A, and a portion of Table 10-L-l, are reproduced with permission of the International Organization for Standardization, ISO. This standard can be obtained from any ISO member and from the Web site of ISO Central Secretariat at the following address www.iso.org. Copyright remains with ISO. 

Quality assurance is defined by Donaobedian as all actions taken to establish, protect, promote, and improve the quality of health care (Donobedian 2003). He describes quality of care as an attribute of a system (structure), a set of organized activities (process), and an outcome that results from both. The definitions are described in Table 3.1. It should be noted that the efficacy of a drug (the ability for improvement under the most favourable circumstances) is included in the structure and that the effectiveness of a dmg (real improvement in the care) is included in the process. 

MIL-STD-105 — Sampling Procedures and Tables for inspection by Attributes MIL-STD-109 — Quality Assurance Terms and Definitions... 

A dynamic simulation uses the ingredients dissected from a complex system to attempt the construction of a model which exhibits dynamic attributes, i.e. emergent behaviour. Such a simulation is more complicated than the static models from which it is derived. Attempts are made to incorporate into these simulations the transactions and interactions that we know are there but which elude a precise definition. Comparisons are made with observables to ascertain some degree of the quality of a model. 

A simpler and perhaps more concise definition might state Power quality is a set of electrical boundaries that allows a piece of equipment to function in its intended manner without significant loss of performance or life expectancy. This definition embraces two things that we demand from an electrical device performance and life expectancy. Any power-related problem that compromises either attribute is a power quality concern. In light of this definition of power quality, this chapter provides an introduction to the more common power quality terms. Along with definitions of the terms, explanations are included in parentheses where necessary. This chapter also attempts to explain how power quality factors interact in an electrical system. 

Inherent is defined as existing in something as a permanent and inseparable element, quality, or attribute (1). A chemical process can be described as inherently safer if it reduces or eliminates a hazard when compared to another process alternative. To understand this definition, it is necessary to understand what is meant... 

DQIs are usually thought of as attributes of a laboratory measurement system. However, a broader definition of primary DQIs will enable us to assess the entire measurement system that includes not only the laboratory measurements but also the sampling design and field procedures. Such broad interpretation of the primary DQIs will allow us to evaluate all components of total error and with it the overall, not just the analytical, data quality. The DQI definitions (EPA, 1999a) presented in this chapter are interpreted in a manner that encompasses all qualitative and quantitative components of total error. 

In summary, destination image studies are evolving in the tourism literature. Armed with more comprehensive and holistic definitions, the work has begun not just to consider basic ratings of destination attributes but to facilitate a wider coverage of the term with affective and orientation components built on the sensory and particularly visual qualities of places. This development in tourist behaviour research represents a useful precursor to the applied topic of how people choose their travel destinations. 

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