怎样做好GMP的验证.docVIP

Risk Analysis Mixer-granulation dry-mixing time granulation liquid; amount, temperature, time mixing intensity wet mixing time granulation end-point drying temperature drying time Tablets compressing speed compressing force load level of blend feeding feeding hardness friability weight uniformity content uniformity disintegration time dissolution rate Capsules flow behavior of granules - compaction pressure filling speed load level of blend feeding powder bed level weight uniformity content uniformity dissolution rate Oral liquid manufacture stirring time type of stirrer, speed standing time up to filling temperature of vessel jacket for heating filter (type, retention rate, etc.) weight/volume of content accuracy of filling filling speed temperature pH viscosity refractive index Accuracy - this means the closeness between the analyzed value and the actual value. This test should be done in at least three concentrations, each repeated at least three times. Recovery rate should be 95% - 105%. Precision - this means the closeness between all the analyzed values. Each analyzed value should be repeated 6 times. RSD for chemical and instrumental analysis should be not greater than 1.5% 2.0% respectively. Specificity - this means the capability of the method to accurately analyze the intended component and not be interfered by the presence of other components Analysis limit - this means that the method needs not report the quantitative result. It only needs to report higher than or lower than certain value. Detection limit - this means the lowest value at which the method could analyze or detect. Linearity - this means that the relationship between the reported values by the analytical methods, and the actual parameters of the material (e.g. concentration of component A or solubility of product B etc), is linear. Range - this means the values between the highest and lowest levels. Cleaning validation Principles and objectives Cleaning method and procedure Which