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The WHO GMPs for pharmaceutical products [5] require that quality control evaluate the stability of nished pharmaceutical products and, when necessary, of starting materials and intermediate products The guideline requires that a written stability program be developed and implemented to generate the stability data Expiration dates and shelf life speci cations should be based on stability data generated under de ned storage conditions The WHO guideline also speci es that stability should be determined prior to marketing and following any signi cant change in, for example, process, equipment, and packaging materials..



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For example, some general business rules might be: The nearest clerk greets customers by saying Welcome to Cloud Nine when they enter the store. Clerks ask to see a customer s ID when writing a check for more than $20 or charging more than $50. No signature is required when charging less than $25. Whoever unlocks the door in the morning makes the rst pot of coffee (or risks mutiny). Save the good scotch for the landlord.





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This is the aspect defined earlier in the chapter for demonstration purposes. Each aspect resides within the <aop:config> element. Each <aop:aspect> element defines an id attribute and a ref element. The id attribute is a simple identifier and the ref to another bean is pretty important because it s a reference to the aspect; it s the so-called aspect-backing bean. The object being advised needs to be a Spring-defined bean. Notice that there are a pointcut and some advice defined in this example as well. These are the next candidates for examination.

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As mentioned above, MPLS can be implemented with different kinds of label distributon protocols. It does not establish standard rules for choosing which label distribution protocol to use in which circumstances. Nevertheless, it is still worthwhile to point out the following considerations. 10.2.5.1 Border Gateway Protocol (BGP) In many scenarios, it is desirable to bind labels to FECs that can be identified with routes to address prefixes. If there is a standard, widely deployed routing algorithm that distributes those routes, it can be argued that label distribution is best achieved by piggybacking the label distribution on the distribution of the routes themselves. BGP distributes such routes. If a BGP speaker needs to also distribute labels to its BGP peers, using BGP to do the label distribution w5x has a number of advantages. In particular, it permits BGP route reflectors to distribute labels, thus providing a significant scalability advantage over using label distributions protocol between BGP peers. 10.2.5.2 Labels for RSVP Flowspecs When RSVP is used to set up resource reservations for particular flows, it is desirable to label the packets in those flows, so that the RSVP filter spec does not need to be applied at each hop. Some suggested that having RSVP distribute the labels as part of its path-reservation setup process is the most efficient method of distributing labels for this purpose w11x. Figure 10.5 shows an example of how labels are carried in one RESV message in order from R 5 to R1.

3.1.9 REQUIREMENTS ANALYSIS FOR SYSTEM PRODUCT, PROCESS, AND SERVICE DESIGN INNOVATION Processes in a successful innovation project must satisfy requirements set by the market, the sponsors, and/or the inventor s own dreams. Requirements analysis is considered to be one of the most important features of any innovative pharmaceutical manufacturing system project, because if done professionally, it helps to specify, research, and develop appropriate features and processes that customers need. In our innovation project examples we have focused on generic needs and requirements, and our associated customers are the pharmaceutical R&D team members, managers, and operators in various industries. In terms of our research approach, we have followed a proven method: Analyze the needs and the requirements, the demonstrated processes, and the methods and systems they try to or have to satisfy, and if you nd a gap , you have found an innovation opportunity. Note that when we search for this gap, it will simultaneously appear as a missing process in our CIMpgr model or as an existing process but missing attributes as well as a requirement in our CORA model (componentoriented requirements analysis) model:

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