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Volumn , Issue , 2004, Pages 1-374

Sterile product facility design and project management, second edition

(1)  Odum, Jeffery N a  

a NONE

Author keywords

[No Author keywords available]

Indexed keywords


EID: 85057500148     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Book
Times cited : (4)

References (38)
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    • (1990)
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    • (1990)
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    • Part 211.46, Washington, DC: U.S. Government Printing Office
    • Code of Federal Regulations, Title 21, Part 211.46. 1990. Washington, DC: U.S. Government Printing Office.
    • (1990)
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    • 85057506824 scopus 로고    scopus 로고
    • Q7A Good manufacturing practice guide for active pharmaceutical ingredients
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    • (2000) Guidance for Industry (November)
  • 9
    • 85057491383 scopus 로고
    • Ongoing issues in the management and operation of biotech cleanrooms
    • Weiss, M. 1992. Ongoing issues in the management and operation of biotech cleanrooms. Genetic Engineering News (November).
    • (1992) Genetic Engineering News (November)
    • Weiss, M.1
  • 10
    • 85057473822 scopus 로고    scopus 로고
    • Title 21, Part 211.42. 1990. Washington, DC: U.S. Government Printing Office
    • Code of Federal Regulations, Title 21, Part 211.42. 1990. Washington, DC: U.S. Government Printing Office.
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    • The ISPE Commissioning and Qualification (C&Q) Baseline Guide
    • The ISPE Commissioning and Qualification (C&Q) Baseline Guide.
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    • (1985) 2Nd College Edition
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    • 85057485802 scopus 로고
    • Washington, DC: U.S. Government Printing Office
    • Code of Federal Regulations, Title 21, Part 211.42. 1990. Washington, DC: U.S. Government Printing Office.
    • (1990) Part 211.42
  • 15
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    • Washington, DC: Centers for Disease Control and National Institutes of Health
    • Guidelines for research involving recombinant DNA molecules. 1994. Washington, DC: Centers for Disease Control and National Institutes of Health.
    • (1994) Guidelines for Research Involving Recombinant DNA Molecules
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    • Rockville, MD: Food and Drug Administration
    • Guideline for the inspection of biotechnology manufacturing facilities. 1991. Rockville, MD: Food and Drug Administration, Division of Field Investigations (HFC-130).
    • (1991) Division of Field Investigations (HFC-130)
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    • Code of Federal Regulations, Title 21, Parts 600–680. 1992. Washington, DC: U.S. Government Printing Office.
    • (1992) Parts 600–680
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    • 85057453141 scopus 로고
    • Title 21, Part 211.42, Washington, DC: U.S. Government Printing Office
    • Code of Federal Regulations, Title 21, Part 211.42. 1990. Washington, DC: U.S. Government Printing Office.
    • (1990)
  • 29
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    • Code of Federal Regulations, Title 21, Part 211.28. 1990. Washington, DC: U.S. Government Printing Office.
    • (1990) Part 211.28
  • 31
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    • Rockville, MD: Food and Drug Administration
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    • (1991) Division of Field Investigations (HFC-130)
  • 33
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    • Cleaning validation. 1992. Mid-Atlantic region inspection guide. Rockville, MD: Food and Drug Administration.
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    • The validation of cleaning procedures
    • Hardec, S. W. 1984. The validation of cleaning procedures. Pharmaceutical Technology 8 (5).
    • (1984) Pharmaceutical Technology , vol.8 , Issue.5
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    • Washington, DC
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    • Burrill & Company. 2003. Biotech 2003.
    • (2003)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.