Regulatory requirements INDEX

Fig. 3 Pharmaceutical development cost Development cost denoted for various mainly chemical pharmaceuticals, including vaccine projects. Correlation with rising regulatory requirements as indicated by the counts of existing guidelines at the indicated point of time. Average consumer cost index for a household of four persons taken from figures released by the Feral German Statistics Office (Statistisches Bundesamt). Graphs show relative figures adjusted to a uniform scale.

In order to investigate the regulatory operability of the process, additionally the anticipated ranges of disturbances needs to be specified, that will define the Expected Disturbance Space (EDS). For the steady-state case, the EDS may also reflect the uncertainties in some of the important model parameters employed in the design, such as kinetic constants, heats of reaction, heat-transfer coefficients, etc. The regulatory operability index is defined from the inputs required to compensate for the effect of disturbances while maintaining the plant at its nominal set point, as ... 

Guidance such as Letters of Interpretation, OSHA contact information, a glossary, and an index are provided for reference purposes. While this information does not mandate requirements, it nonetheless provides vital information should additional guidance be necessary. This will help ensure continued compliance with regulatory requirements. 

NCRP notes that the modifying factor in the risk index should be applied independently of the requirement to achieve a negligible risk or dose for exempt waste or an acceptable (barely tolerable) risk or dose for nonexempt waste, in order to provide regulatory flexibility in classifying particular wastes. NCRP believes that such flexibility is highly desirable to promote cost-effective management and disposal of waste, provided it is applied in a transparent manner. 

The pharmaceutical industry has been required by regulatory authorities to take a strong interest in polymorphism and solvatomorphism once it was realized that the nature of the structure adopted by a given compound upon crystallization would then exert a profound effect on the solid-state properties of that system. For a given material, the heat capacity, conductivity, volume, density, viscosity, surface tension, diffusivity, crystal hardness, crystal shape and color, refractive index, electrolytic conductivity, melting or sublimation properties, latent heat of fusion, heat of solution, solubility, dissolution rate, enthalpy of transitions, phase diagrams, stability, hygroscopicity, and rates of reactions, were all affected by the nature of the crystal structure. 

MHRA (2006) EC medical devices directives guidance notes for manufacturers of class 1 medical devices. Medicines and Healthcare Regulatory Agency MHRA (2009) http //www.mhra.gov.uk/index.htm. Accessed 16 September 2009 MOD (1997) Defence Standard 00-55 Issue 2 Requirements for S ety Related Software in Defence Equipment. Ministry of Defence... 

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