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Volumn 59, Issue 2, 2005, Pages 118-126

Aseptic processing contamination case studies and the pharmaceutical quality system

Author keywords

[No Author keywords available]

Indexed keywords

AGENTS ACTING ON THE EYE; PARENTERAL SOLUTION;

EID: 25144485364     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (13)

References (34)
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  • 8
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    • The Davonport incident, the clothier report, and related matters - 30 Years on
    • Matthews, Brian R. The Davonport Incident, the Clothier Report, and Related Matters-30 Years On. PDA Journal of Pharmaceutical Science & Technology. 2002, 56 (3), 137-149
    • (2002) PDA Journal of Pharmaceutical Science & Technology , vol.56 , Issue.3 , pp. 137-149
    • Matthews, B.R.1
  • 9
    • 0024592783 scopus 로고
    • Current regulatory issues regarding parenteral inspections
    • Avallone, H. Current regulatory issues regarding parenteral inspections. Journal of Parenteral Science and Technology 1989, 43(1), 3-7
    • (1989) Journal of Parenteral Science and Technology , vol.43 , Issue.1 , pp. 3-7
    • Avallone, H.1
  • 12
    • 25144432661 scopus 로고    scopus 로고
    • Corrective and preventive action planning to achieve sustainable GMP compliance
    • Snyder J. E. Corrective and preventive action planning to achieve sustainable GMP compliance. Journal of GXP Compliance 2002, 6(3), 29-39.
    • (2002) Journal of GXP Compliance , vol.6 , Issue.3 , pp. 29-39
    • Snyder, J.E.1
  • 13
    • 25144442006 scopus 로고    scopus 로고
    • Baseline pharmaceutical engineering guide for sterile manufacturing facilities
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  • 16
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    • 21 CFR 210 and 211, US Food & Drug Administration, US Printing Office
    • 21 CFR 210 and 211, US Food & Drug Administration, US Printing Office.
  • 21
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    • The scientific method: Application to FDA regulated industry. Part I of III
    • Goode, R.; Evans, K. The scientific method: application to FDA regulated industry. Part I of III. Journal of Validation Technology 2003, 10(1), 37-43.
    • (2003) Journal of Validation Technology , vol.10 , Issue.1 , pp. 37-43
    • Goode, R.1    Evans, K.2
  • 24
    • 25144433156 scopus 로고    scopus 로고
    • Chapter 19. Training and learning: Critical contributors to quality
    • Prince, R., Ed.; DHI Publishing: River Grove, IL
    • Vesper, J. L. Chapter 19. Training and Learning: Critical Contributors to Quality. In Pharmaceutical Quality; Prince, R., Ed.; DHI Publishing: River Grove, IL, 2004.
    • (2004) Pharmaceutical Quality
    • Vesper, J.L.1
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    • FDA Advisory Committee for Pharmaceutical Science, October 22, 2002
    • FDA Advisory Committee for Pharmaceutical Science, October 22, 2002.
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    • Performance of blow/fill/seal equipment under controlled airborne microbial challenges
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    • (1995) PDA Journal of Pharmaceutical Science & Technology , vol.49 , Issue.6 , pp. 294-299
    • Sinclair, C.S.1    Tallentire, A.2
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    • Design and operational qualification of a vapor-phase hydrogen peroxide biological indicator evaluator resistometer (BIER) unit
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    • The cost of non-conformance: The linkage between quality performance and business results
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    • Dwyer, T.1    Keresty, G.2    Sherry, B.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.