Requirements Related to the Product

The standard requires that design input requirements relating to the product be identified and documented and product life, reliability, durability, and maintainability objectives be included in the design inputs. 

The organization reviews the requirements related to the product prior to the organization s commitment to supply a product to the customer (e.g., submission of tenders, acceptance of contracts of orders, acceptance of changes to contracts or orders) to ensure that ... 

The [design department] and [plant product engineering] ensure that the design input requirements relating to the product are identihed, documented, and their selection is reviewed to ensure adequacy. Incomplete, ambiguous, or conhicting requirements are resolved when dehn-ing these requirements. 

Requirements based testing is the first objective for any level of integration. The tests should show the correct implementation of the given requirements related to the product but also relevant by the given standards, particularly here ISO 26262. 

A problem is the difference between the way things are and the way things ought to be, as perceived by the one identifying it. A problem relating to the product, process, or quality system (or quality problem) is therefore a difference between what has been achieved and what is required. There is no requirement in this clause for you to actually identify and record such problems (see below). You are only required to define the... 

The literature is a rich source of information related to food products and processing. Journal articles provide extensive information, although the chances of finding an exact how to process for converting an RAC into an EPA-required processed commodity are minimal. Most journal articles deal with in-depth research and discussion of a single topic in the process or related to the product. An experienced food technologist could piece together information from several sources to define a process. 

A chemical product property must be observable, measurable or otherwise known characteristics related to the product. Therefore, when a property cannot be measured or when there is not a clear definition, then congruent properties are required with the desired property. This is especially important when the environment is the human being because the product properties depend not only on the closest characteristics of the niche, but also on human being tastes and preferences. 

Records include materials transfer records, batch records, materials/inter-mediates/finished product test records, shipping records, water test records, and environmental test records. They provide an audit trail for reviewing all the information related to the production of any batch of drug product. The data are required to be reviewed for product release. 

Under Directive 2004/27/EC, there are various changes to the information to be included on the product label and certain provisions relating to the product s package leaflet. There is also a new requirement for the name of the medicinal product to be expressed in Braille format on the label. For products containing up to three active substances, the legislation specifies that the international non-proprietary name (INN) must also appear on the labelling. The MAH must also ensure that the package leaflet is made... 

Another important feature of GAs is that they are tunable. This means that we can define the algorithm s fitness function to reflect the actual requirements from the catalyst. An optimal catalyst exhibits high activity, high stability, and high selectivity. These three figures of merit are directly related to the product yield, the turnover number (TON) and the turnover frequency (TOF), respectively. Often, however, an increase in one comes at the expense of another. Using GAs you can... 

Facilities and Equipment The technical experts who have an understanding of pharmaceutical science, risk factors, and manufacturing processes related to the product are responsible for defining specific facility and equipment requirements. The equipment must be qualified, calibrated, cleaned, and maintained to prevent contamination and product mix-ups. It is important to remember that the GMPs place as much emphasis on process equipment as on testing equipment while most quality systems focus only on testing equipment. Control Outsourced Operations Quality systems call for contracts with outside suppliers that clearly describe the materials or service, quality specification responsibilities, and communication mechanisms. 

An important quantity that can be deduced from the reaction profile is the rate of the cross-linking polymerization (Rp), i.e., the number of double bonds polymerized or of cross-links formed per second. Rp values were determined from the maximum slope of the kinetic curves (usually reached for conversion degrees between 20 and 40%). Table I summarizes the Rp values for the two photoresists tested under various conditions, namely conventional UV and continuous or pulsed laser irradiation at different light intensities. According to these kinetic data, Rp increases almost as fast as the light-intensity the ratio Io/Rp which is directly related to the product of the light-intensity and the required exposure time was found to vary only in the range 10-8 to... 

If concerns are found, a deficiency letter will be sent, and if the deficiencies are serious enough to delay clinical trials the agency will impose a clinical hold on the product that can be lifted after the deficiencies are corrected. Clinical holds are classified as complete or partial, depending on whether the issues relate to the product or its manufacture or are specifically related to protocol concerns. Application sponsors should respond to clinical hold notifications promptly. Additionally, FDA is required to respond to completed responses within 30 days of receipt. Examples of reasons for clinical holds are... 

Mathematically the autocorrelation function (Figure 4.5) of the scattered hght G(Ndt) in Equation (4.9) is related to the product of the two hght intensities that are separated by a time interval dt. If dt is chosen correctly, that is, is within the time period required for diffusion to occur into and out of the control volume, then the diffusion coefficient can be calculated from the decay of the autocorrelation function over an observation interval of Ndt (Figure 4.5). 

Energy requirement and other data related to the production of 1 kg of 100 per cent H202 by all methods described are indicated in Table 19. 

From a rubber it is essentially demanded to elongate under stress, to withstand stress without breaking and to reversibly find back to its original shape after the stress ceases. An unfilled, cured polymer will rarely fulfill these requirements this is a fact, which is true for most rubber-like systems. The industrial development of elastomers therefore is strongly related to the production of active reinforcing fillers. 

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