QUALITY RISK MANAGEMENT IN THE PHARMACEUTICAL INDUSTRY

被引:0
|
作者
Dimeny, Gabor [1 ]
Popescu, Sorin [1 ]
机构
[1] Gedeon Richter Romania SA, Targu Mures, Romania
来源
BUSINESS EXCELLENCE | 2006年
关键词
risk management; quality risk management;
D O I
暂无
中图分类号
K9 [地理];
学科分类号
0705 ;
摘要
The paper presents a short general review of the elements related to Quality Risk Management (QRM) in the pharmaceutical industry. General approach of Partitioned Multi-objective Risk Method, like a statistical tool of QRM, some elements of extreme events statistics in relation with the process capability and its application to a case study are also presented.
引用
收藏
页码:129 / 134
页数:6
相关论文
共 50 条
  • [31] Quality Risk Management in Pharmaceutical Manufacturing Operations: Case Study for Sterile Product Filling and Final Product Handling Stage
    Alsaidalani, Rawidh
    Elmadhoun, Bassam
    SUSTAINABILITY, 2022, 14 (15)
  • [32] Characteristics, risk management and GMP standards of pharmaceutical companies in China
    Chen, Hong
    Qin, Lijian
    Jiang, Cong
    Qin, Mingshuai
    Sun, Yanming
    Luo, Jingjing
    FRONTIERS IN PUBLIC HEALTH, 2023, 11
  • [33] Sustainable risk management in the construction industry: lessons learned from the IT industry
    Hwang, Bon-Gang
    Chen, Meiru
    TECHNOLOGICAL AND ECONOMIC DEVELOPMENT OF ECONOMY, 2015, 21 (02) : 216 - 231
  • [34] Mastering Quality: Uniting Risk Assessment With Quality by Design (QbD) Principles for Pharmaceutical Excellence
    Kaleem, Abdul M.
    Koilpillai, Jebastin
    Narayanasamy, Damodharan
    CUREUS JOURNAL OF MEDICAL SCIENCE, 2024, 16 (08)
  • [35] Internet of Things and the Risk Management Approach in the Pharmaceutical Supply Chain
    Montoya, Giset N.
    Santos Junior, Jose Benedito S.
    Novaes, Antonio G. N.
    Lima, Orlando F., Jr.
    DYNAMICS IN LOGISTICS, 2018, : 284 - 288
  • [36] Pharmaceutical industry perspective on risk evaluation and mitigation strategies: manufacturer take heed
    Nicholson, Susan
    Peterson, Janet
    Yektashenas, Behin
    EXPERT OPINION ON DRUG SAFETY, 2012, 11 (02) : 299 - 314
  • [37] Some Aspects of Quality Risk Management for the Fenspiride Hydrochloride (0.08 G Coated Tablets) Production Process at the Pharmaceutical Development Stage
    S. N. Kashutskii
    S. V. Rusanova
    S. I. Dikhtyarev
    A. V. Dorovskoi
    Pharmaceutical Chemistry Journal, 2016, 49 : 771 - 775
  • [38] SOME ASPECTS OF QUALITY RISK MANAGEMENT FOR THE FENSPIRIDE HYDROCHLORIDE (0.08 G COATED TABLETS) PRODUCTION PROCESS AT THE PHARMACEUTICAL DEVELOPMENT STAGE
    Kashutskii, S. N.
    Rusanova, S. V.
    Dikhtyarev, S. I.
    Dorovskoi, A. V.
    PHARMACEUTICAL CHEMISTRY JOURNAL, 2016, 49 (11) : 771 - 775
  • [39] QUALITY ASSURANCE AND RISK MANAGEMENT IN JAPAN
    SATO, N
    MEDICAL & BIOLOGICAL ENGINEERING & COMPUTING, 1994, 32 (04) : 411 - 415
  • [40] RISK MANAGEMENT IN NORMALIZED QUALITY SYSTEMS
    Scierski, Jerzy M.
    AKTUALNE PROBLEMY PODNIKOVEJ SFERY 2012, 2012, : 454 - 462