Regulatory guidelines method development documentation

As with any physical measurement, sample preparation is of utmost importance. This is particularly true for particle size determinations. If the measurement is performed in suspension, dispersing aids may have to be added and ultrasound may have to be apphed to ensure homogeneous dispersion. This may disrupt aggregates, which can be desired or undesired. In any case, it is highly advisable to observe the effects of sample preparation by additional methods such as microscopy. Guidelines for method development, instrument calibration, and acceptance criteria can be found in regulatory documents. ... 

Although the requirements of validation have been documented clearly by regulatory authorities, the approach to validation is varied and open to interpretation. The approach listed here focuses on ICH guidelines. Also, because validation requirements differ during the development process of pharmaceuticals, the requirements for later phases in development and for methods used to evaluate marketed products cannot be overemphasized. 

Development of regulatory documents on nuclear safety (e.g., rules, standards, guidelines, manuals, requirements for methods, tools of control over parameters). 

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