Experiment planning regulations

Implementation of effective pre-experiment review programs must be initiated and backed by the highest level of leadership in an organization. Primary responsibility for day-to-day implementation of such programs should rest with individuals who supervise particular laboratory activities. While the experiments may be prepared and conducted by the laboratory workers, it remains the responsibility of the laboratory supervisor to determine what level of experiment planning is appropriate and to be accountable for necessary training, documentation, and compliance with regulations. 

The Material Safety Data Sheet (MSDS) for each hazardous chemical is one of the resources that should be incorporated into experiment planning. However, because of the inconsistent quality of information found in MSDSs, Laboratory Chemical Safety Summaries (LCSSs), which are compiled in Appendix B, should be consulted or developed for the materials involved. In any case, the experiment planner needs to be aware that the existing regulations do not necessarily represent the full complement of prudent practices for handling hazardous materials and that other input is therefore essential. 

Regulations are an intrinsic part of modern laboratory work that cannot be separated easily from other matters and should be considered at each step of experiment planning. It is only prudent for laboratory workers and supervisors to ensure regulatory compliance in conducting laboratory experiments. However, the responsibility of leadership goes beyond compliance to the protection of individual laboratory workers. 

A sponsor of a medical product entering the development phase must have a clinical development plan, which is created by experienced executives and consultants having expertise and experience in the disease state for which the product is intended. Once the plan is created, with appropriate input from regulators, the plan drives a clinical development budget, with consideration of the desired timeframe for projected producf approval. After the plan is created, the management team determines the "make vs. buy" strategy, which determines the elements of fhe plan that will be outsourced. 

Khogeer (2005) developed an LP model for multiple refinery coordination. He developed different scenarios to experiment with the effect of catastrophic failure and different environmental regulation changes on the refineries performance. This work was developed using commercial planning software (Aspen PIMS). In his study, there was no model representation of the refineries systems or clear simultaneous representation of optimization objective functions. Such an approach deprives the study of its generalities and limits the scope to a narrow application. Furthermore, no process integration or capacity expansions were considered. 

Extent of Validation Depends on Type of Method On the one hand, the extent of validation and the choice of performance parameters to be evaluated depend on the status and experience of the analytical method. On the other hand, the validation plan is determined by the analytical requirement(s) as defined on the basis of customer needs or as laid down in regulations. When the method has been fully validated according to an international protocol [63,68] before, the laboratory does not need to conduct extensive in-house validation studies. It must only verify that it can achieve the same performance characteristics as outlined in the collaborative study. As a minimum, precision, bias, linearity, and ruggedness studies should be undertaken. Similar limited vahdation is required in cases where it concerns a fully validated method which is apphed to a new matrix, a well-established but noncol-laboratively studied method, and a scientifically pubhshed method with characteristics given. More profound validation is needed for methods pubhshed as such in the literature, without any characteristic given, and for methods developed in-house [84]. 

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