工艺验证方案

86（300mg）工艺验证方案

86 (300mg) PROCESS VALIDATIONPROTOCOL

86（300mg）

86 (300mg )

工艺验证方案

共35 页第1 页PROCESS VALIDATIONPROTOCOL

修订记录History 文件编号File code

版本Version

页数Page

V-0382（P）

V 01

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***公司

86（300mg ）工艺验证方案

86 (300mg) PROCESS VALIDATIONPROTOCOL

作者签名 Signature of th authoro

共 35 页

第 2 页

您的签名表明这份文件的准备（编制/修订）符合企业验证主计划、工艺验证主计划、GMP 规范和企 业生产的要求，并且充分反映了工艺验证全过程中应完成的必要任务，可以付诸对86 工艺验证的实施。

The signature means the drafting/revising confirms to validation master plan, process validation master plan, GMP,

and in-house specifications. It includes all the contents need to be validated that can be applied to the process validation

of 86 tablets.

审核签名 Checking signature

您的签名表明您已经仔细审阅了本文件，确认它正确并已全面反映了验证任务，可以付诸对 86 工艺

验证的实施。

The signature means the protocol is checked thoroughly and carefully. It includes all the contents need to be

validated that can be applied to the process validation of 86 tablets.

批准签名 Approv a Signaturer

您的签名表明这份文件符合企业验证主计划、工艺验证主计划、企业生产检验标准以及现行的 GMP

规范，并且在此包含的文件和信息是充分的，并可直接应用。

The signature means the drafting/revising confirms to validation master plan, process validation master plan, GMP,

and in-house specifications. It includes all the contents need to be validated that can be applied directly.

86（300mg）工艺验证方案

86 (300mg) PROCESS VALIDATIONPROTOCOL

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目录

TABLE OF CONTENTS

1 目的OBJECTIVES (3)

2 验证范围SCOPE (3)

3 方案审查PROTOCOL REVIEWING (3)

4 组织与责任RESPONSIBILITIES (4)

5 概述INTRODUCTION (4)

6 处方、工艺流程和验证关键控制项目FORMULATION/PROCESS/ CRITICAL PARAMETERS IN VALIDATION (5)

6.1 处方FORMULATION (5)

6.2 工艺流程PROCESS (6)

6.3 验证关键控制项目CRITICAL PARAMETERS IN VALIDATION (7)

7 验证用物料及主要设备RAW MATERIALS AND EQUIPMENTS (9)

7.1 原辅料和包衣材料进行确认RAW MATERIALS CHECK (9)

7.2 主要设备进行确认EQUIPMENTS CHECK (9)

8 验证程序及内容VALIDATION PROCEDURE AND CONTENT (9)

8.1 配料DISPENSING (10)

8.2 浆液的配制GRANULATION SOLUTION PREPARATION (10)

8.3 干粉混合DRY MIXING (11)

8.4 制粒GRANULATION (11)

8.5 湿颗粒整粒WET MILLING (12)

8.6 沸腾干燥FLUID BED DRYING (12)

8.7 干颗粒整粒DRY MILLING (14)

8.8 总混MIXING (16)

8.9 压片COMPRESSION (20)

8.10 包衣COATING (24)

9 偏差分析与说明DEVIATION ANALYSIS AND EXPLANATION (32)

10 验证结果分析和结论VALIDATION RESULTS AND CONCLUSION (33)

11 参考文献REFERENCE (34)

12 附件APPENDICES (34)

名称：偏差清单DEVIATION LIST (35)

86（300mg）工艺验证方案

86 (300mg) PROCESS VALIDATIONPROTOCOL

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1目的OBJECTIVES

为了验证86（300mg）的生产工艺规程，确保大生产的稳定性，在本厂现有的设备和环境条件下连续验证生产三批的86，批量为100 万片，对生产中的关键步骤和工艺参数进行确认。批号待定。

In order to confirm the manufactur ing process of 86 tablets (300mg), 3 consecutive batches of 1.00 million 86

tablets will be produced on the arranged equipments under the current environment condition. The critical stage and

parameters will be finalized in the process to ensure the robustness of the regular production. The batch number will be

arranged in validating.

2验证范围SCOPE

本方案适用于生产洁净区一线设备的86 的工艺验证。

The protocol is applied to the process validation of 86 tablets (300mg) that produced in work line 1.

3方案审查PROTOCOL REVIEWING

下列时机应对本方案进行审查以确保方案的适宜性

Review the protocol in the following condition

——产品处方发生变更；

Changing formulation

——产品的工艺步骤、工艺参数和批量发生变更；

Changing process, parameters and batch size

——产品所使用的原料供应商发生变更；

Changing raw materials supplier

——产品所使用的原料的生产工艺发生变更；

Changing raw materials manufacturing process

——产品所涉及的设施设备发生变更；

Changing equipments

——产品的生产环境发生变更；

Changing manufacturing environment