Importance and globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients

被引：23
|
作者：
Abdellah, Abubaker [1 ]
Noordin, Mohamed Ibrahim [1 ]
Ismail, Wan Azman Wan [1 ]
机构：
[1] Univ Malaya, Fac Med, Dept Pharm, Kuala Lumpur 50603, Malaysia
来源：
SAUDI PHARMACEUTICAL JOURNAL | 2015年 / 23卷 / 01期
关键词：
Globalization; Importance of pharmaceutical excipients; Good manufacturing practice; Excipient's evaluation; Excipient's Safety;
D O I：
10.1016/j.jsps.2013.06.003
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
Pharmaceutical excipients are no longer inert materials but it is effective and able to improve the characteristics of the products' quality, stability, functionality, safety, solubility and acceptance of patients. It can interact with the active ingredients and alter the medicament characteristics. The globalization of medicines' supply enhances the importance of globalized good manufacturing practice (GMP) requirements for pharmaceutical excipients. This review was intended to assess the globalization status of good manufacturing practice (GMP) requirements for pharmaceutical excipients. The review outcomes demonstrate that there is a lack of accurately defined methods to evaluate and measure excipients' safety. Furthermore good manufacturing practice requirements for excipients are not effectively globalized. (C) 2013 Production and hosting by Elsevier B.V. on behalf of King Saud University.
引用
收藏
页码：9 / 13
页数：5
相关论文
共 50 条
  • [1] Vendor qualification for pharmaceutical excipients - GMP requirements and approach
    Patel, K. T.
    Chotai, N. P.
    [J]. PHARMAZIE, 2010, 65 (11): : 783 - 790
  • [2] GAP•GMP (Good Agricultural Practice and Good Manufacturing Practice)
    不详
    [J]. JOURNAL OF THE JAPANESE SOCIETY FOR FOOD SCIENCE AND TECHNOLOGY-NIPPON SHOKUHIN KAGAKU KOGAKU KAISHI, 1999, 46 (10): : 672 - 672
  • [3] Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
    不详
    [J]. WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS - THIRTY-FIFTH REPORT, 1999, 885 : 50 - 71
  • [4] Good Manufacturing Practice (GMP) and Declaration of Conformity for food Commodities: Specification of Requirements.
    Altkofer, Werner
    Brauer, Beate
    Grob, Konrad
    Haffke, Helma
    Helling, Ruediger
    [J]. JOURNAL FUR VERBRAUCHERSCHUTZ UND LEBENSMITTELSICHERHEIT-JOURNAL OF CONSUMER PROTECTION AND FOOD SAFETY, 2010, 5 (01): : 111 - 122
  • [5] IMPLEMENTATION STATUS AND BARRIERS OF GOOD MANUFACTURING PRACTICE (GMP) FOR CHINESE PATENT MEDICINE
    He, Tian Tian
    Hu, Hao
    Wang, Yi Tao
    [J]. AFRICAN JOURNAL OF TRADITIONAL COMPLEMENTARY AND ALTERNATIVE MEDICINES, 2015, 12 (04) : 56 - 64
  • [6] GMP - Good modelling practice: An essential component of good manufacturing practice
    Kell, DB
    Sonnleitner, B
    [J]. TRENDS IN BIOTECHNOLOGY, 1995, 13 (11) : 481 - 492
  • [7] Development of a good manufacturing practice (GMP) facility
    Yufit, T.
    Carson, P.
    Kwak, T.
    Iwamoto, S.
    Fiore, D.
    Falanga, V.
    [J]. JOURNAL OF INVESTIGATIVE DERMATOLOGY, 2009, 129 : S45 - S45
  • [8] GMP(GHP)/SSOP GMP(Good Manufacturing Practice) GHP(Good Hygiene Procedure)
    [J]. 猪业科学, 2003, (05) : 30 - 30
  • [9] Good Manufacturing Practice (GMP) in cane sugar factories
    Bernhardt, HW
    Raschke, A
    [J]. PROCEEDINGS OF THE SEVENTY-SECOND ANNUAL CONGRESS OF THE SOUTH AFRICAN SUGAR TECHNOLOGISTS' ASSOCIATION, 1998, : 215 - 218
  • [10] Requirements engineering practice in pharmaceutical and healthcare manufacturing
    Prakash, S
    Aurum, A
    Cox, K
    [J]. 11TH ASIA-PACIFIC SOFTWARE ENGINEERING CONFERENCE, PROCEEDINGS, 2004, : 402 - 409
12345