Key quality attributes

That type of fixation on product quality for a single product family might seem excessive, but is certainly preferable to the more prevalent benign neglect that passes for validation of product quality in many firms. Each of the key quality attributes of the product should be established in a validation effort that establishes the consistent conformance to the specifications. As mentioned previously the PQ effort should consist of independent confirmation of process parameters coupled with in-process and finished goods sampling of production materials. The combination of parameter verification with product sampling ties the process to the product. 

Key stability attribute (KSA) An attribute which may/will influence API shelf life when stored at fixed conditions. KSAs are a subset of key quality attributes (KQAs). 

A key component in any quality system is appropriately responding to nonconformities (i.e., deviations from requirements established under the quality system for in-process material or final product quality attributes, process control parameters, records, procedures, etc.). Nonconformities may be detected during any stage of the... 

The focus of the validation program is usually the quality attributes of the system implementation, change control, and the verification and testing of modifications made to the baseline system. The configuration management of the system, including its documentation, is a key area of concern. Specifically, documentation management is extremely critical for the information contained in both the master production records, and in the application. 

Often, protective levels or other criteria for various chemicals in environmental media are developed. This characterization includes an evaluation of the data quality, specific assumptions, and uncertainties associated with each step, and the level of confidence in the resulting criteria. Alternative risk characterizations are also discussed. Specific key qualities, or attributes, of risk characterizations have been identified [American Industrial Health Council (AIHC), 1992 U.S. EPA, 2000b]. 

Process validation is documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-deter-mined specifications and quality attributes [48]. For cell culture-derived biopharmaceuticals, important quality attributes to establish include structural integrity and potency of the API and freedom from impurities. Thus, the demonstration of removal of cell culture and process impurities is a key part of process validation. Often, due to practical considerations, some studies are performed at small scale. In these cases, periodic concurrent monitoring of impurities during large-scale production can confirm the results from small-scale studies. 

A key aspect to a supplier s QMS for standard software products is its application to new product release. Without appropriate qualification of new developments, the quality attributes of the original system may be lost. Pharmaceutical industry customers are looking for consistent, if not improving, quality compliance, and this is especially so with product upgrades. 

Table 10.12 lists key power-quality attributes that should be considered when assessing the need for power-conditioning hardware. The limits of acceptable power input are shown in graphical form in Fig. 10.121. 

Given the detailed background of MBP process and other considerations discussed previously, this section aims to provide additional tools for troubleshooting in case a problem arises. The key components of developing MBP depend on three components API, polymer, and process. Troubleshooting needs to be evaluated with respect to its impact on the critical quality attributes as well as the process. Summary of various processes and the key considerations is provided in Table 11.3. 

A very much abbreviated and simple example of one of the first steps in the process of developing fuel cell system specihcations is shown in Fig. 14.3. This example is for a residential stationary fuel cell application, but similar requirements are relevant in most other fuel cell applications. Here is shown the high-level VOC, gathered by some technique such as the use of customer interviews or focus groups and the system attributes that will influence their achievement, arranged in order of importance. As shown, some of the key system attributes that are critical to quality (CTQs) and that influence the customer s demand for clean, quiet, safe, and... 

Foam has a clearly aesthetic utility in many detergent and personal care products although it may not add much to the overall effectiveness of the product. Although of secondary importance in terms of functional performance, foam properties like speed, quantity, quality, and longevity are key signal attributes for many cleansing products. 

Quality in Japan. Japanese economic prowess has been attributed variously to such quahty improvement activities as quahty circles, statistical process control (SPG), just-in-time dehvery (JIT), and zero defects (ZD). However, the real key to success hes in the apphcation of numerous quahty improvement tools as part of a management philosophy called Kaizen, which means continuous improvement (10). 

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 ... 

Additionally, color may also serve as a key to cataloging a food as safe. Undesirable colors of meats, fruits, and vegetables warn us about potential dangers or at least of the presence of undesirable flavors. Color and other sensory attributes are even misused as indicators for safety. Walker and co-authors demonstrated that in small and medium enterprises, more than 50% of food handlers thought that they could tell whether food was contaminated with food poisoning bacteria by sight, smell, and taste. Color is thus used as a way to identify a food and judge its quality."... 

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