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reported that the SP6 tail gene is anked by an upstream region that contains a promoter and a downstream region that contains a putative Rho-independent transcription terminator, giving it a cassette or modular structure almost identical to the structure of the tail genes of coliphages K1E, K5, and K1-5 (Scholl et al 2002) It was concluded that phages SP6, K1-5, K5, and K1E are very closely related but have different tail ber proteins, which allows each phage to have different host speci cities (Scholl et al 2002) The observation of a similar tail genome motif in both the Salmonella phage SP6 and the coliphages K1E, K5, and K1-5 indicates that this genomic construct might serve in the development of a modular phage platform that could operate over a wide bacterial host range The presence of such host range platforms is described more fully below.





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The use of risk management techniques in identifying product requirements, establishing processes and process control and monitoring methods, evaluating quality data, identifying appropriate corrective and preventive actions to address quality problems, and for other quality-related activities can increase the overall ef ciency and effectiveness of the quality system. The FDA has recognized the value of and encourages a risk based quality systems approach for the manufacture of pharmaceutical products. This is re ected in its Pharmaceutical CGMPs for the 21st Century Initiative. In association with this initiative the FDA has published reports and guidance documents that collectively provide information that can be used by pharmaceutical product manufacturers in implementing a quality systems and risk management approach to pharmaceutical cGMP regulations compliance [5 8]. In implementing this initiative, the FDA has made it clear that it does not impose new regulatory requirements on manufacturers. The FDA has provided information and guidance that is intended to serve as a bridge between the 1978 regulations and current quality systems by explaining how manufacturers implementing such systems can do so in full compliance with the cGMP regulations. This approach differs from that used by the FDA when it updated the cGMP regulations for medical devices to employ a quality systems approach. The 1996 Quality System Regulation updated the GMP requirements for nished medical device manufacturers to reduce the risk of inadequate device design and to harmonize them with international quality system standards that were in effect at that time [9]. These international standards have since been updated [10]; however the device quality system regulation remains consistent with modern quality system models. In a modern quality system, the organizational unit responsible for qualityrelated activities within the organization generally has a central role in the

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progress through this chapter, that some of the same examples are used. For now, it s important to know only that there are many types of expressions and that not all are interchangeable you cannot put any type of expression into all parts of SQL statements that require expressions.

structure are topological entities, geometric classi cation, and adjacencies between entities Topology provides an unambiguous, shape-independent abstraction of the mesh With reasonable restrictions on the topology [4], a mesh can be effectively represented with only the basic 0- to d-dimensional topological entities, where d is the dimension of the domain of interest The full set of mesh entities in 3D is {{M{M 0 }}, {M{M 1 }}, {M{M 2 }}, {M{M 3 }}}, where {M{Mid }}, d = 0, 1, 2, 3, are, respectively, the set of vertices, edges, faces, and regions Mesh edges, faces, and regions are bounded by the lower order mesh entities Geometric classi cation de nes the relation of a mesh to a geometric model.

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