口服固体制剂工艺验证指南SOP.docVIP

生效 H 期 Effective Date: 下次审核口期 Next Review Date: 替代文件编号 Supersedes Document No.: 职能 Role 部门 Dept 签名日期 Signature Date 文件发放部门及分发号Distributed Departments No. 1?目的 PURPOSE 木程序旨在为口服固体制剂产品工艺验证提供指导，确保制剂产品的工艺验证过程符合相 关注册法规和质量法规的要求。 The SOP is intended to provide a validation guideline for the Oral Solid Dosage Forms to ensure all the validation campaigns conform to related registration statute and quality requirements. 对于具有特姝工艺步骤及特性的产品或代加工(OEM)产品的工艺验证，可根据经验和可 获得的某些产品资料(如产品技术转移报告)，设计特定的取样、检测和可接受标准，并 在验证方案中给出科学的说明。 Some processes have specific process steps or process characteristics or the contract manufacturing product (OEM), which will require special sampling, testing and acceptance criteria. Based on experience and available information with a certain product (e.g. product technical transfer report), a scientific rationale shall be declared clearly in the protocol to modify the sampling plan, testing and acceptance criteria. 2?范围 SCOPE 本程序适用于* * *所有的片剂和胶囊剂产品的工艺验证。包括新工艺的最初验证及随后 的工艺改进验证(如原辅料、生产设备、生产工艺的变更)以及再验证。 This guideline applies to all tablets and capsules at * * * *, including the initial validation of new processes, subsequent validation of modified processes (e.g. raw materials, equipment and process change) and revalidation. 定义 DEFINITIONS 工艺验证 Process Validation 证明特定的生产工艺能够始终如一地生产出符合预定的质量标准和质量特征产品的有 文件证明的一系列活动。 Process Validation is the establishment of documented evidence which provides a high degree of assurance that a specific process will consistently produce a product that meets predetermined specifications and quality characteristics. 前验证 Prospective validation 在新产品上市销售前或对产品特征有影响的生产工艺发生变更，进行的验证活动。 Validation conducted prior to the distribution of either a new product, or a product made under a revised manufacturing process, where the revisions may affect the product^ attributes. 同步验证 Concurrent Validation 对于预先计划的产品上市与产品销售同步进行的验证。应具备相对常规检测而加强的 取样和检测计划。 Concurrent validation is performed as a preplanned activity on a marketed product concurrently with product