Current Good Manufacturing Practice Design Trends in Active Pharmaceutical Ingredients Facilities

被引:0
|
作者
Louis A. Angelucci
机构
[1] Foster-Wheeler USA Corporation,Worldwide Validation, Pharmaceuticals and Life Sciences
关键词
GMPs; Compliance; Validation; APIs; Facility; Trends;
D O I
暂无
中图分类号
学科分类号
摘要
Since the early 1990s, the Food and Drug Administration (FDA) has focused attention on Good Manufacturing Practice (GMP) compliance within the active pharmaceutical ingredients (API) industry. Over the years, as well as recently, this industry has striven to play catch-up and comply. This paper discusses both general and specific API industry trends associated with this increased compliance effort.
引用
收藏
页码:739 / 746
页数:7
相关论文
共 50 条
  • [1] Current good manufacturing practice design trends in active pharmaceutical ingredients facilities
    Angelucci, LA
    DRUG INFORMATION JOURNAL, 1999, 33 (03): : 739 - 746
  • [2] Continuous Manufacturing of Active Pharmaceutical Ingredients: Current Trends and Perspectives
    Hyer, Andres
    Gregory, Daniel
    Kay, Kaitlin
    Le, Quang
    Turnage, Justin
    Gupton, Frank
    Ferri, James K.
    ADVANCED SYNTHESIS & CATALYSIS, 2024, 366 (03) : 357 - 389
  • [3] Environmental loadings of Active Pharmaceutical Ingredients from manufacturing facilities in Canada
    Kleywegt, Sonya
    Payne, Mark
    Ng, Fai
    Fletcher, Tim
    SCIENCE OF THE TOTAL ENVIRONMENT, 2019, 646 : 257 - 264
  • [4] Current good manufacturing practice regulations for pharmaceutical laboratories
    Schier, J
    LC GC-MAGAZINE OF SEPARATION SCIENCE, 1995, 13 (06): : 474 - &
  • [5] Manufacturing peptides as active pharmaceutical ingredients
    Zompra, Aikaterini A.
    Galanis, Athanassios S.
    Werbitzky, Oleg
    Albericio, Fernando
    FUTURE MEDICINAL CHEMISTRY, 2009, 1 (02) : 361 - 377
  • [6] The process improvement of manufacturing active pharmaceutical ingredients
    Chen, Chiwei
    Pao, Lu-Sheng
    Lei, Hong
    Hsieh, Meng-Zhi
    ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, 2022, 18 : 57 - 58
  • [7] Managing emissions of active pharmaceutical ingredients from manufacturing facilities: An environmental quality standard approach
    Murray-Smith, Richard J.
    Coombe, Vyvyan T.
    Gronlund, Marie Haag
    Waern, Fredrik
    Baird, James A.
    INTEGRATED ENVIRONMENTAL ASSESSMENT AND MANAGEMENT, 2012, 8 (02) : 320 - 330
  • [8] Proposed rule: Current good manufacturing practice in manufacturing, packing, or holding dietary ingredients and dietary supplements
    Melethil, S
    LIFE SCIENCES, 2006, 78 (18) : 2049 - 2053
  • [9] Application of Green Chemistry in the Active Pharmaceutical Ingredients Manufacturing
    Tonini, Marlon Daniel L.
    Lopes, Raquel de O.
    Barbosa, Maria Leticia C.
    REVISTA VIRTUAL DE QUIMICA, 2024, 16 (04) : 635 - 646
  • [10] CURRENT GOOD MANUFACTURING PRACTICE
    CROWLEY, CD
    FOOD DRUG COSMETIC LAW JOURNAL, 1966, 21 (03): : 137 - 144