粒度方法验证.docx

通则General Physical tests performed for release purposes need to be validated. The physical test that is comprised in this validation procedure is Particle Size Distribution by Laser Diffraction Instruments. This SOP can serve as the validation protocol for validating a method for particle size distribution. A separate validation protocol is necessary in case of an exception from this SOP.当物理测试作为放行目的的时候应被验证。本验证程序中包含的物理测试是通过激光粒度仪测试样品的粒度分布。该SOP可以作为验证粒度分布方法的协议。若有异议，可以有一个单独的验证方案。目的2. purpose2.1 To define the typical analytical parameters that should be considered when a validation of an analytical method is performed.当执行一个分析方法验证的时候，应考虑典型分析参数的定义。2.2 To describe the way in which a method is validated according to these parameters描述按照这些参数进行方法验证的方法。2.3 To establish acceptance criteria for acceptance / rejection of drug substances, finished products or other materials.建立原料药，成品或其它原料的放行/拒绝标准。范围3. Range责任4. Responsibility 4.1 Physical RD laboratory analyst – performance of all laboratories studies required for method validation according to this SOP. 4.2 Physical RD Laboratory manager – 4.2.1 Verification to compliance of this Physical RD laboratory with GMP regulations and this SOP. 4.2.2 Approval of validation protocol (when applicable) and validation report. 4.3 QC Laboratory manager (only if an interlaboratory study is performed in the QC laboratory): 4.3.1 Verification of compliance of the QC laboratory, with GMP regulations with this SOP and the validation protocol. 4.3.2 To perform the Interlaboratory study.4.3.3 Approval of validation protocol (when applicable) and validation report. 4.4 QA manager – approval of validation protocol (when applicable) and validation report.分析参数的定义DEFINITION OF ANALYTICAL PARAMETERSIn order to prove the analytical capability of a method that assesses physical properties of powder or other solid materials, three main analytical parameters are relevant:为了证明分析方法的可行性，评估粉末或其它固体原料的物理性质，下面三个主要的分析参数是比较重要的：Precision 精密度Accuracy 准确度Robustness 耐用性精密度5