设备清洁验证方案

PROCEDURES/INSTRUCTIONS

设备清洁验证方案

Equipments Cleaning Qualification Protocol

文件编号Doc. No.:

文件版本Revision:

修订日期Revision Date:

拟案单位Issued by:

编辑Author审核Approved by

校对Reviewed by日期Effective Date

1. 概述Description

Dermasil OTC 产品生产设备组由真空乳化搅拌锅组和液体自动填充机组成。主材采用不锈钢，易清洗，耐消毒。造型美观大方，各系统转动灵活、平稳，温度调节灵敏、易控制。该组设备主要生产活性成分相同的护肤产品。微生物控制尤为重要。

Manufacturing equipment for Dermasil OTC skincare product includes vacuum emulsification mix tank group & Liquid Automatic Filling Machine. These equipments adopt stainless steel materials, and facilitate cleaning and resist disinfection. They are easy to control and have good design, flexible and stable system, sensitive temperature adjusting. These equipments are used to produce skin care products with same active ingredients. Control the microorganism is significant.

2. 目的Purpose

检查并确认OTC生产设备清洁规程制定是否具有可操作性和科学性，保证清洗后的设备能够满足工艺要求。

This is to check and verify if these equipments for OTC products are scientific and designed to facilitate operation.

3. 范围Scope

3.1. 本验证方案主要适用于以下Dermasil OTC护肤产品生产设备的清洁验证。

This protocol is applied for cleaning qualification of these equipments for Demersil OTC Skincare

4. 职责Role & Responsibilities

4.1. QA manager

4.1.1.负责指派验证小组组长，负责验证方案及报告批准，发放验证证书，确认再验证周期。

Assign team leader, approve validation protocol and reports, issue validation certificate and

decide re-validation frequency.

4.2. 验证小组组长Team leader

4.2.1.即具体验证项目的主导人，主导和协调验证工作，负责方案的起草，记录数据的收集以

及报告整理。

Team leader is the leader of specific qualification projects, lead to and coordinate qualification assignment, draft the protocol and collect the data and records and sort out reports.

4.2.2.负责首次清洁验证方案的起草，完成报告。并指导验证实施、培训及技术移转。

Draft first cleaning validation protocol and complete the reports, and guide the implementation, training and technical transfer of the qualification.

4.3. QA

4.3.1.负责验证数据及结果的审核，Review of qualification data and results.

4.3.2.负责验证过程的监督和验证报告的审批。

Supervise the qualification and review validation report.

4.3.3.负责验证文件管理。Manage qualification documents.

4.3.4.负责验证管理的日常工作，制定验证计划及监督实施，验证方案管理，验证工作的协调，

验证文件的管理。

Develop validation plan and supervise the implementation of validation and manage the documents.

4.4. 实验室LAB

4.4.1.负责制定清洁后残留物（产品残留、微生物、清洁剂等）的检测方法和残留限度。

Develop inspection methods and limits of residue (products left, microorganism, cleaning agent).

4.4.2.负责制定取样方法和执行取样，并对清洁验证的结果进行评价。Establish sampling methods

and sample for tests, and evaluate the qualification results.

4.4.3.负责对生产选用清洁剂种类及清洁方法进行指导。Guide the production department to

choose cleaning agent and cleaning methods.

4.5. 生产部Production

4.5.1.负责制定清洁作业指导书，执行清洁操作以及对操作人员的培训和考核。Make the

procedure for cleaning and conduct cleaning activities and do training for the operators.