胡-SMP-ZL-026-03产品稳定性试验程序.docVIP

产品稳定性试验程序 Procedures for product stability test 1.目的：建立产品稳定性试验规程，检验产品在有效期内的稳定性，为产品的生产、包装、贮存、运输条件以及制定和调整产品的有效期提供依据。 Purpose: establishing procedures for product stability test, test the stability within shelf life, supplying data for manufacturing, packaging, storage, transportation, estimate or adjust the expiry date. 2.范围： 适用于须进行稳定性试验的产品。 Scope: it is applicable to product which stability test is needed. 3.责任人：质量管理部负责人、质量管理部稳定性考察人员。 Responsibilities: the person in charge of quality department, person in charge of retain sample. 4.内容：稳定性试验包括一般留样试验和重点留样试验。 Content: stability test including common retain sample and focal point retain sample. 4.1 质量管理部每年制订本公司产品的稳定性试验计划，制定原则是： Quality department formulates the stability test every tear, the principle is: 4.1.1 一般留样 Common retain sample 4.1.1.1 常年生产品种做一般留样试验（按生产计划留样），每年生产少于10批的考察1批，每年生产10～25批的考察2批；每年生产大于25批的考察3批。 Normal products do the common retain sample, observe one batch if less than 10 batches being manufactured each year, 2 batches if between 10～25 batches each year, 3 batches if more than 25 batches. 4.1.1.2 一般留样的试验条件为该品种的贮存条件。 The experimental condition of common retain sample is the storage condition. 4.1.2 重点留样：原料药重点留样试验须做影响因素试验、加速试验和长期试验，制剂药重点留样试验须做加速试验和长期试验。 Focal point retain sample:, accelerate test, long-term test should be done on raw materials, accelerate test, long-term test should be done on finished products. 4.1.2.1 重点留样的品种分新品，永久性变更的品种和临时性变更的品种。 Focal point retain sample products can be divided into new products, permanency modified products and modified products. 4.1.2.1.1 新品投产的前三批须列入试验计划内。 The first three batches of new drug should be on the test plan. 4.1.2.1.2 当作出永久性变更，如处方、生产工艺或内包装材料的变更及主要原辅料供应商改变，变更后前三批须列入试验计划内。 When the formulation, processing, primary materials or suppliers of main raw materials and excipient was changed permanency, the first three batches should be on the test plan. 4.1.2.1.3 当作出临时性变更，如处方、生产工艺或内包装材料的临时变更，主要原辅料供应商临时改变及不符合内控标准，该批必须包括在试验计划内。临时性变更的产品在加速试验完成前不得作合格处理。 When the