Process capability worked example

It should also be taken into account that CROs base their lab work, qualification, validation, and documentation on their historically developed systems, which may differ from those of the sending lab. Here, a good early understanding of the capabilities of the receiving lab should be established, and their impact on the transfer process evaluated. For example, availability of raw data based on the LIMS used, software versions, limitations based on 21 CFR Part 11-compliant software used, delays in reporting data due to internal reviews, and compatibility issues of software to... 

In Chapter 2 we showed how the mean, x, of a sample of measurements could be used to provide an estimate of the popuiation mean, pi, and how the sample standard deviation, s, provided an estimate of the population standard deviation, a. For a small sample size, n, the confidence iimits of the mean are normally given by equation (2.9), with the t value chosen according to the number of degrees of freedom (k - 1) and the confidence ievei required. The same principles can be applied to quality control work, but with one important difference. Over a long period, the population standard deviation, second example, of the tablet weights) wiii become known from experience. In quality control work, ais given the title process capability. Equation (2.9) can be replaced by equation (2.8) with the estimate s replaced by the known a. In practice z = 1.96 is often rounded to 2 for 95% confidence limits and z = 2.97 is rounded to 3 for 99.7% confidence limits. 

Virtually all separation processes taught to chemical engineering students in a variety of courses have heen covered via the approach illustrated in Chapters 3, 4, 6, 7 and 8 in addition, many particle separation methods have been treated. The structural similarity in the separation method between apparently unrelated separation processes becomes quite clear. A few basic principles equip the students with the capability to understand a wide variety of separation processes and techniques, including emerging ones. To aid the student, there are 118 worked examples, 300 problems, 340 figures, 100 tables and 1011... 

All equipment has limitations, for example, the amount of a substance it can detect or the accuracy with which it can make a measurement. If you attempt to make the equipment perform beyond its capabilities, it does not matter how carefully the equipment is operated, it will not be possible to get meaningful results. In terms of a particular instrument, fitness for purpose is interpreted as having appropriate performance capability to do the work required. This applies to all equipment, large or small. For example, a stirrer needs to perform the intended task satisfactorily while remaining essentially inert. There is a formal process for assessing the suitability of equipment to perform a given task - this is called Equipment Qualification or Equipment Validation. This is dealt with in Section 5.6.3. 

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