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reporting of CMC changes covered by the approved CP . For example, changes that otherwise would require submission, review, and acceptance of a postapproval supplement (PAS) might be designated as annual report (AR) changes if they were provided for in an approved CP. The CP is one of the mechanisms by which the FDA intends to reduce the number of supplements requiring review. Additionally, the CP was designed to facilitate free ow of communication with the agency, thereby reducing the risk that process changes will lead to unexpected regulatory shutdown or delay. Process Validation In agreement with the pursuit of science-based policies, the FDA has begun to revise the 1987 Guideline of General Principles of Process Validation and in March 2004 released a revision of the compliance policy guide (CPG) (Section 490.100) Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval [52]. The current revisions are designed to support continuous improvement and replace the notion of three-batch validation. The CPG describes the concept that, after having identi ed and established control of all critical sources of variability, conformance batches are prepared to demonstrate that under normal conditions and operating parameters the process results in the production of acceptable product. However, the CPG does not describe how many conformance batches are required; rather, the manufacturer is expected to provide sound rationale for the procedure they choose to follow in demonstrating validation. The ambiguity in the revised (CPG) regulations may seem to signify that manufacturers would need to undertake even more extensive validation exercises when in fact the CPG contains language providing a pathway for batch release to market distribution concurrent with the manufacture of initial conformance batches or with a single conformance batch [57]:

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16 Oct 2016 ... In this article, I am going to explain you how to extract images from PDF file using itextsharp in asp.net with C# . First, you need to download ...

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to access points located throughout the city to ensure that all of Anytown s citizenry would have equal access to the Internet service provided by the city For those without personal computers or unable to connect to the citywide wireless network, public access computers would be located at schools and libraries With his presentation completed, the IS chief asked if there were any questions The mayor seemed pensive at rst and then asked, Can you explain why there is only wireless Internet for the public The IS chief said, Yes, sir, I can He went on to explain that the infrastructure cost to bring a wired Internet alternative to all of the city inhabitants would drive costs for the project beyond reach of the city s budget.

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Figure 11.8a shows the variation of output energy (Eout) and re ectivity (Eout/Ein) as a function of input energy (Ein) for a small signal gain in the ampli ers of G0 50 and with the NRTE adjusted to give a forward transmission factor T jt j2 % 0.0015. Figure 11.8a also displays the buildup time, de ned as the time delay between peak of input and peak of output radiation. Figure 11.8b contains the numerical results of the equivalent modeled system using the transient system of Eq. (24) together with boundary conditions of the loop geometry of Fig. 11.6. Numerical uence units (U/Us) are normalized to saturation uence (Us 550 mJ/ cm2 in Nd:YAG [6, 23]) and can be compared with experimental data by using the relation Uin Ein/pw2 , where the input beam radius win 1.9 mm in this example. in Examples of the temporal pulse traces are shown in Fig. 11.9a for a range of input energy and corresponding numerically computed pulses are shown in Fig. 11.9b. From the graph of Fig. 11.8a it is seen that there is a threshold input energy of 75 mJ required to initiate the oscillator and that the output energy rises with increasing input energy. At an input energy *4 mJ, the output maximizes at *330 mJ corresponding to *30% optical energy extraction ef ciency of the 1.1-J stored energy in both rods for the small signal gain of 50. A maximum re ectivity of *700 is reached at an input energy of *0.17 mJ. When the ampli er gains were raised to G 125, the output re ectivity reached values greater than 10,000 times [21].

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