Conditions or criteria

All personnel involved in GMP production of drugs have to take ownership of quality. It is a requirement that processes and equipment for drug manufacturing must be approved and operated by trained, qualified personnel. Quality-related activities have to be recorded to enable traceability of data and information. Deviations and excursions of processes and results from specified conditions or criteria have to be reported, investigated, and resolved. Drug products have to be tested and must meet specifications before being... 

If conditions or criteria are used to help the user make a decision or recognize a condition, the conditions precede the action. 

If one has some independent knowledge about the sample material, such as whether the size distribution is unimodal or multimodal, or narrow or broad, the incorporation of such knowledge into the matrix inversion procedure may help to obtain a better result, since the fitting procedme can then be finely tuned using these known conditions or criteria. For example, certain pre-tuned conditions can be used if the distribution s modality is known, or smoothing techniques can be used to create a more realistic distribution. The drawback of such "pre-choices" is that in most instances pre-fixing a distribution shape will... 

The definition of an overlap syndrome dictates that the criteria for diagnosis of both disorders (in the present context, of PM/DM and of some other connective tissue disorder), are fulfilled. It is not unexpected that those syndromes which overlap with PM/DM are also either known autoimmune conditions or ones in which an autoimmune basis is strongly suspected. The association of these disorders with PM/DM syndromes may not materially alter the basic histopathological featmes expected in PM/DM but some differences may be identifiable. The disorders most frequently associated with an overlap syndrome are rheumatoid arthritis, systemic lupus erythematosis, scleroderma, and mixed connective tissue disease. 

To identify comparable non-critical areas, N02 and PM levels and the trend of these pollutants were analysed in cities across the EU. Taking the criteria for non-critical areas into account, Berlin was selected as a comparable non-critical area.7 Other cities or areas which fit the criteria for non-critical areas either have a special emission structure (which eases abatement measures), or they are comparably small, or largely comparable to Berlin with respect to their dispersion conditions or modal split of traffic in several cases the available information about air quality assessment and management is not enough. Therefore, Berlin is the only non-critical area which is discussed here in detail. 

As shown in Table 3.4, acceptance criteria for stabilization parameters may have a range of recommended values. Because some are more stringent than others, they should be used with caution and be adjusted as necessary based on the knowledge of site-specific conditions. For example, the criterion for turbidity of + 10 percent may be too stringent for some hydrogeological conditions or for the conventional sampling method. On the other hand, this criterion may be easily achieved for wells with dedicated submersible pumps and non-turbid, clear groundwater. 

Reproductive and developmental toxicity data from animal experiments and human studies should be assessed based on defined criteria. One of the following judgments can be made either the toxicity data are sufficient (or insufficient) to ascribe an adverse effect to a specific agent under specified conditions, or the data are sufficient (or insufficient) to conclude that there is no adverse effect. To be characterized as sufficient, the database must include information on the full range of potential adverse male and female reproductive effects and developmental effects, and the actual range of conditions of exposure must be known in sufficient detail to determine whether the dose, duration,... 

Sufficient versus insufficient evidence. Three generic criteria are applied to describe data that are insufficient (1) there are no data, (2) deficiency in study design or insufficient detail available to allow analysis, and P) data are insufficient to reach a definitive conclusion. The evaluative process requires a uvight of evidence approach to determine (insufficiency of data as summarized in a narrative document. The evaluation process determines whether the collective toxicity data ore (insufficient to judge that there is an adverse effect under specified exposure conditions or whether the data are (insufficient to conclude the absence of adverse effects under specified exposure condition. 

While there are significant differences between what is required to drill a well on land and in a marine or offshore environment, the basic mission is very similar. The differences in location conditions, design criteria, logistical considerations and related cost are enormous, hi deepwater, the process can approach the most sophisticated technical operations known to man and an individual well can cost in excess of sixty million dollars, often to be paid early in the project life well before surety of the results of the effort is known. 

---