论文总字数：12466字

摘 要

本文主要叙述药品生产设备在生产中的清洁验证和清洁验证中检测残留物的几种可行方法，并且以企业某固体制剂药物生产为实例，使用紫外-可见分光光度法对固体线设备进行清洁验证的方法学验证，测试该方法的可行性。全文包括三部分，考虑到清洁验证的方法学验证是以清洁验证为基础的，很多论文均人为模拟残留物进行清洁验证从而对某分析方法验证其可行性，所以第一部分帮助简述了清洁和清洁验证的信息，包括了清洁验证的主要环节：选择溶剂，选择清洁方法，如何判断清洁完成，清洁完成后选择取样方法，第二部分主要介绍三种除紫外-可见分光光度法外其他检测分析方法，并未深入探讨，本文着重分析经济适用的紫外-可见分光光度法，并在第三部分的实例验证中以生产固体制剂A为例进行一次完整的方法学验证并给出数据和分析。

【关键词】清洁验证；方法学验证；固体制剂

QC Method Validation for Solid Line Equipment Cleaning

Abstract

This paper mainly describes several feasible methods for detecting residues in the cleaning verification and cleaning verification of pharmaceutical production equipment, and uses the UV-visible spectrophotometry to clean the solid line equipment by taking the production of a solid preparation drug as an example. Methodological verification to test the feasibility of the method. The full text consists of three parts. Considering that the method validation of cleaning verification is based on cleaning verification, many papers are used for cleaning verification of simulated residues to verify the feasibility of an analytical method, so the first part briefly help describes cleaning and cleaning. The verification information includes the main aspects of cleaning verification: solvent selection, cleaning method, how to judge cleaning completion, sampling method after cleaning, etc. The second part introduces four main methods for detecting residues. The economical UV-visible spectrophotometry, and in the case of the third part of the example verification, a complete methodological verification was carried out with the production of solid preparation A as an example and data and analysis were given.

【Key words】Cleaning verification; method validation; solid preparation

目录

摘要 ……………………………………………………………………………………………………………I

Abstract ………………………………………………………………………………………………………II

第一章 清洁、清洁验证与清洁验证的方法学验证 …………………………………………………………1

1.1概述……………………………………………………………………………………………………1

1.2清洁验证的残留物检测前过程………………………………………………………………………1

1.2.1清洁溶剂的选择…………………………………………………………………………………2

1.2.2清洁方法的选择…………………………………………………………………………………2

1.2.3判断清洁是否已完成标准………………………………………………………………………2

1.2.4取样方法…………………………………………………………………………………………2

1.3清洁验证方法学验证的实施…………………………………………………………………………2

第二章 清洁验证中检测方法分析 ……………………………………………………………………………4

2.1固体线设备残留物检测方法的选择…………………………………………………………………4

2.1.1 高效液相色谱法…………………………………………………………………………………4

2.1.2 薄层层析法………………………………………………………………………………………4

2.1.3 紫外-可见分光光度法…………………………………………………………………………4

2.1.4 TOC法…………………………………………………………………………………………4

2.2 检测项目和结果的要求 ………………………………………………………………………………4

第三章 固体线设备清洁方法学验证实例 ……………………………………………………………………6

3.1验证目的、方式与要求…………………………………………………………………………………6

3.2验证过程与验证结果分析……………………………………………………………………………6

3.2.1 线性………………………………………………………………………………………………6

3.2.2专属性……………………………………………………………………………………………7

3.2.3准确度……………………………………………………………………………………………7

3.2.4精密度…………………………………………………………………………………………8

3.2.5耐用性…………………………………………………………………………………………9

总结 ……………………………………………………………………………………………………9

1. 结束语…………………………………………………………………………………………………11

致谢……………………………………………………………………………………………………………11

参考文献（references） ……………………………………………………………………………………12

第一章 清洁、清洁验证与清洁验证的方法学验证

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