EN
Submit
Register
Online Submission Pre-typesetting Academic Support
Home > Wen Yuan (Middle School Edition) > 2020 No.03 > 药品GMP质量管理体系中变更控制、偏差管理、质量风险管理分析

  • 药品GMP质量管理体系中变更控制、偏差管理、质量风险管理分析

    Author(s)：

    陆琳

    Publication Title：

    Wen Yuan (Middle School Edition) 2020 No.03

    Affiliations：

    华北制药金坦生物技术股份有限公司

    Abstract：

    药品GMP质量管理体系包括变更控制、偏差管理、质量管理等。变更控制能够及时调整生产进度，提高对药品质量的监测水平，降低药品安全事故发生概率。偏差管理是对药品生产过程中的异常现象进行分析，找出问题并提出相应的解决措施，以减少药品质量安全事故。质量风险管理是指通过对风险进行预测、判断，根据现有的风险状况，制定相应的对策，逐步降低风险，改善产品的质量。

    Keywords：

    GMP体系；变更控制；偏差管理；质量风险管理

    Views
    6
    Citations
    0
    Downloads
    0
    Favorites
    0
    Full Text
    Download PDF
    Cite
    Favorited
    Favorite
    Share via WeChat

    Scan to share on WeChat

    Mobile Reading

    Scan to read on mobile

    Cite
    Copy

    [1] 陆琳.药品GMP质量管理体系中变更控制、偏差管理、质量风险管理分析[J].Wen Yuan (Middle School Edition),2020(03),.

文渊(中学版)
Wen Yuan (Middle School Edition)

Language: 中文

CN：11-9275/G

ISSN：2096-627X

Publication Frequency: 月刊

Recommended Articles
Friendship Link

An academic processing and support platform focusing on journal databases, submission and review, and pre-typesetting.

OpenScirbe Publishing
Pre-typesetting
Article Retrieval
News
Latest news
Industry news
Academic Support
Language editing
Translation
International dissemination
Journal
Wen Yuan (Primary School Edition)
Wen Yuan (Middle School Edition)
Wen Yuan (High School Edition)
Urban and Rural Studies
Contact Us
027-59496650
Office
Room 510, Office Tower, Optics Valley Financial Center, 668 Gaoxin Avenue, Donghu New Technology Development Zone, Wuhan, Hubei Province
User Agreement Privacy Policy
鄂ICP备2026003587号-1 copyright 2026 All rights reserved. Tel:027-59496650 鄂公网安备42018502009073号