Scope of Guidelines

If your organization does not have a Quality Management system, you can still apply many of the concepts described in these guidelines. However, you will still need to identify a pervasive, consistent management system within which to conduct the integration. 

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A complete analysis of dense gas dispersion is much beyond the scope of this treatise. More detailed references are available (Britter and McQuaid, Workbook on the Dispersion of Dense Gases, Health and Safety Executive Report No. 17/1988, England, 1988 Lees, 1986, pp. 455 61 Hanna and Drivas, 1987 Workbook of Test Cases for Vapor Cloud Source Dispersion Models, AlChE, 1989 Guidelines for Chemical Process Quantitative Risk Analysis, 1989, pp. 96-103). 

The guidelines presented are simplified and may not be sufficient for all applications. This does not mean that an axial cannot be used, because the vendors can perform a much more complex analysis and change factors that this simplified method chose to hold constant. Undoing some of these values is probably beyond the scope of most of the users. The best way to interpret a potential application is that an extra measure of care might be exercised when going out for bid. This can generate additional questions concerning the vendor s proposal. 

The similarity solution for a flow field in front of a steady piston is a special case from a much larger class of similarity solutions in which certain well-defined variations in piston speed are allowed (Guirguis et al. 1983). The similarity postulate for variable piston speed solutions, however, sets stringent conditions for the gas-dynamic state of the ambient medium. These conditions are unrealistic within the scope of these guidelines, so discussion is confined to constant-velocity solutions. 

It is beyond the scope of this book to go though all the specifics of catalyst testing and to discuss all pitfalls that may arise. Instead we list the Ten Commandments for the Testing of Catalysts. This is a set of guidelines that have been provided by experts of a company called Catalytica [F.M. Dautzenberg in Characterization of Catalyst Development An Iterative Approach (Eds. S.A. Bradley, M.J. Gattuso, R.J. Ber-tolacini), ACS Symposium Series, Vol. 411 (1989)]. 

Pediatric Patients There are unique considerations in the treatment of HIV-infected children. Specific treatment guidelines exist,23 but a thorough review is outside the scope of this chapter. Most children acquire HIV infection through... 

A wide variety of technical and process safety management issues are referenced throughout these guidelines. Detailed coverage of these issues is outside the scope of this book, and readers are referred to other CCPS books for more information. These include, in particular ... 

Before undertaking a discussion of the mathematics involved in the determination of reaction rates is undertaken, it is necessary to point out the importance of proper data acquisition in stability testing. Applications of rate equations and predictions are meaningful only if the data utilized in such processes are collected using valid statistical and analytical procedures. It is beyond the scope of this chapter to discuss the proper statistical treatments and analytical techniques that should be used in a stability study. Some perspectives in these areas can be obtained by reading the comprehensive review by Meites [84], the paper by P. Wessels et al. [85], and the section on statistical considerations in the stability guidelines published by FDA in 1987 [86] and in the more recent Guidance for Industry published in June 1998 [87],... 

Additional hazards in plant operations include specific gas and dust explosions, but such considerations are outside the scope of this book. Reference can be made to another CCPS Guidelines book [159] for issues relative to certain explosions. 

The guidelines stress, however, that internal quality control is not foolproof even when properly executed. Obviously it is subject to errors of both kinds , i.e. runs that are in control will occasionally be rejected and runs that are out of control occasionally accepted. Of more importance, IQC cannot usually identify sporadic gross errors or short-term disturbances in the analytical system that affect the results for individual test materials. Moreover, inferences based on IQC results are applicable only to test materials that fall within the scope of the analytical method validation. Despite these limitations, which professional experience and diligence can alleviate to a degree, internal quality control is the principal recourse available for ensuring that only data of appropriate quality are released from a laboratory. When properly executed it is very successful. 

Both sets of guidelines attempt to cover most of the types of problems that might arise in the employee-employer relationship and to set forth desirable conditions for employment. The scope of the ACS document can be comprehended by noting the headings in the PEG, which are Terms of Employment, Employment Environment, Professional Development, Termination Conditions, and Investigation of Unprofessional Conduct. Copies of PEG may be obtained from the ACS (3) and the GPEES from the EJC (4). 

EMEA, CHMP. Guideline on therapeutic Areas Within the Mandatory Scope of the Centralised Procedure for Evaluation for Marketing Authorisation Application, October 2005. 

A validation protocol adapted from the experiences during the method development defines the scope of the validation study (goal of the study, regulating guidelines, key method parameters, etc.). To investigate the adequate method performance, these features (e.g., range of analyte concentration), together with a statement of any fitness-for-purpose criteria, have to be specified in the validation protocol. A basic check has to provide that the reasonable assumptions about the principles of the method are not seriously flawed. In this process, sources of error in analysis have to be listed (Table 4) and their effects have to be checked. The validation should, as far as possible, be conducted to provide a realistic survey of the number... 

A detailed discussion of the exact impact of each of these factors is beyond the scope of this chapter. Nevertheless, a few guidelines born out by experience are appropriate. 

The scope of the guidelines has been expanded to include all company-sponsored studies which are carried out to evaluate safety of marketed medicines. It should be emphasised that this includes both studies conducted in general practice and in the hospital setting. The name of the guidelines has been changed to reflect the emphasis on safety assessment rather than merely surveillance. 

In cases of doubt as to whether or not a study comes under the scope of the guidelines the sponsor should discuss the intended study plan with the MCA. 

Due to the copious amount of recent literature pertaining to olefin CM, a comprehensive review would prove repetitive, as this reaction is now a widespread synthetic tool. Fortunately, numerous reviews are now readily available on this subject. This chapter therefore focuses on reports pertaining to important aspects in either the concept or the application of alkene CM. Allene, alkyne, and enyne CM reactions are not included within the scope of this review. Drawing from the examples discussed, a series of general guidelines toward constructing a desired olefin CM transformation will be presented. 

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