GMP/FDA requirements to aseptic production

被引：0
|
作者：
Langer, U
Mangel, A
机构：
[1] Concept Heidelberg, D-69007 Heidelberg, Germany
[2] Univ Mainz Klinikum, Mainz, Germany
来源：
PHARMAZEUTISCHE INDUSTRIE | 2002年 / 64卷 / 04期
关键词：
D O I：
暂无
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
引用
收藏
页码：375 / 383
页数：9
相关论文
共 50 条
  • [21] Documentation and Records: Harmonized GMP Requirements
    Patel, K. T.
    Chotai, N. P.
    JOURNAL OF YOUNG PHARMACISTS, 2011, 3 (02) : 138 - 150
  • [22] GMP REQUIREMENTS FOR BUILDING AND FACILITIES AND FOR EQUIPMENT
    BAUKIN, LM
    FOOD AND DRUG LAW JOURNAL, 1979, 34 (08): : 442 - 449
  • [23] FDA requirements for cGMP compliance and the consequences - Report of "Pharma Congress Production and Technics 2006"
    Martin, Harald
    PHARMAZEUTISCHE INDUSTRIE, 2006, 68 (06): : 756 - 760
  • [24] EMA and FDA Seek Applicants for Joint GMP Inspections
    Sethi, Chitra
    BIOPHARM INTERNATIONAL, 2010, 23 (09) : 12 - 12
  • [25] Robotics and Aseptic Processing in View of Regulatory Requirements
    Tanzini, Andrea
    Ruggeri, Marco
    Bianchi, Eleonora
    Valentino, Caterina
    Vigani, Barbara
    Ferrari, Franca
    Rossi, Silvia
    Giberti, Hermes
    Sandri, Giuseppina
    PHARMACEUTICS, 2023, 15 (06)
  • [26] A Communication Effectiveness Study of the FDA GMP Warning Letters
    Bao, Yiyi
    Zheng, Qiang
    JOURNAL OF PHARMACEUTICAL INNOVATION, 2024, 19 (03)
  • [27] FDA WARNING LETTER ANALYSIS: A TOOL FOR GMP COMPLIANCE
    Patel, Darshit S.
    INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES AND RESEARCH, 2012, 3 (12): : 4592 - 4603
  • [28] GMP REGULATIONS AND PROPER SCOPE OF FDA RULEMAKING AUTHORITY
    FORTE, WE
    GEORGETOWN LAW JOURNAL, 1968, 56 (04) : 688 - 703
  • [29] GMP REGULATIONS AND PROPER SCOPE OF FDA RULEMAKING AUTHORITY
    FORTE, WE
    FOOD DRUG COSMETIC LAW JOURNAL, 1968, 23 (11): : 532 - 549
  • [30] The new FDA aseptic guidance - Part 3: Qualification/Validation
    Seyfarth, H
    PHARMAZEUTISCHE INDUSTRIE, 2005, 67 (12): : 1488 - +
12345