设备清洁验证管理制度.pdfVIP

File Number: Document name: QA-SMP-C06 设备清洁验证管理制度 version: 02 Equipment cleaning validation management system 目的：本文件旨在提供用于原料药和制剂的生产、包装设备清洁验证的基本原则和基本 要求。 Aim: The SMP describes general requirements and principles to validate cleaning procedures to clean equipment for packing, API and dosage manufacturing. 范围：适用于原料药和制剂的生产和包装设备的清洁验证/确认。 Scope: Applicable for equipment cleaning validation/qualification for packing, API and dosage manufacturing 责任：质量保证部、质检科、各生产车间对此程序负责。 Responsibility: The QA, QC and other workshops shall be responsible to this SMP. 内容： Contents: 1.设备清洁验证类型主要有：Equipment cleaning validation includes: 1.1 清洁确认：是指清洁方法正在建立过程中（如引入新的设备和产品），或由于偏差超 标或清洁验证参数有偏离而进行的确认，每次均应制定相应的清洁确认方案。Cleaning qualification refers to any qualification in the establishment of a cleaning method (e.g.: introduction of new equipment and product), cleaning parameter deviations and deviation out of specifications. A cleaning plan for qualification shall be prepared accordingly. 1.2 清洁验证/再验证：如因为引入的新产品或修订过的清洁程序，再验证要确认设备清 洁状态等同于验证状态，应按照清洁验证/再验证方案进行。Cleaning validation/re- validation: If new product is introduced or cleaning procedures are revised, cleaning re-validation shall verify that equipment cleaning status equals to validation status and be implemented according to cleaning validation/re-validation protocols. 2.清洁验证评估的执行，应至少考虑以下方面：The following items shall be taken into consideration during the implementation of cleaning validation assessments: 2.1 产品方面Product -评价某一设备的产品生产过程（特别是多产品生产的设备）以确定设备清洁的最差 条件。Determine the worst condition of equipment cleaning through the assessment of equipment use in manufacturing process (especially for equipment shared in multiple product manufacturing). Page 1 of 13 File Number: Document na