메뉴 건너뛰기




Volumn 12, Issue 1, 2011, Pages 114-118

Quality by design and process analytical technology for sterile products - Where are we now?

Author keywords

process analytical technology (PAT); quality by design (QbD); sterile product

Indexed keywords

AUTOCLAVE; CONTROL STRATEGY; CRITICAL QUALITY ATTRIBUTES; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG RELEASE; EXPERIMENTAL DESIGN; FOOD AND DRUG ADMINISTRATION; INSTRUMENT STERILIZATION; LIFE CYCLE ASSESSMENT; PARTICLE SIZE; PRIORITY JOURNAL; PROCESS ANALYTICAL TECHNOLOGY; PROCESS DESIGN; PROCESS DEVELOPMENT; QUALITY BY DESIGN; QUALITY CONTROL; QUALITY TARGET PRODUCT PROFILE; REVIEW; RISK ASSESSMENT; SOLID;

EID: 79954416743     PISSN: None     EISSN: 15309932     Source Type: Journal    
DOI: 10.1208/s12249-010-9566-x     Document Type: Review
Times cited : (38)

References (25)
  • 3
    • 79954426453 scopus 로고    scopus 로고
    • Food and Drug Administration , Food and Drug Administration. Pharmaceutical quality for the 21st century: a risk-based approach. Rockville: FDA; 2002 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm128080.htm.
    • Food and Drug Administration 2002 Pharmaceutical quality for the 21st century: a risk-based approach FDA Rockville http://www.fda.gov/AboutFDA/ CentersOffices/CDER/ucm128080.htm Food and Drug Administration. Pharmaceutical quality for the 21st century: a risk-based approach. Rockville: FDA; 2002. http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm128080.htm.
    • (2002) Pharmaceutical Quality for the 21st Century: A Risk-based Approach FDA Rockville
  • 5
    • 43349088601 scopus 로고    scopus 로고
    • Pharmaceutical quality by design: Product and process development, understanding and control
    • 10.1007/s11095-007-9511-1
    • LX Yu 2007 Pharmaceutical quality by design: product and process development, understanding and control Pharm Res 25 4 781 791 10.1007/s11095-007-9511-1
    • (2007) Pharm Res , vol.25 , Issue.4 , pp. 781-791
    • Yu, L.X.1
  • 6
    • 79954416859 scopus 로고    scopus 로고
    • Geneva, Switzerland, International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use
    • ICH Q9 Quality Risk Management. Geneva, Switzerland, International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. 2005. http://www.ich.org/LOB/media/MEDIA1957.pdf.
    • (2005) ICH Q9 Quality Risk Management
  • 7
    • 77649213126 scopus 로고    scopus 로고
    • Risk and scientific considerations in the environmental monitoring of isolators in aseptic processing
    • J Akers 2010 Risk and scientific considerations in the environmental monitoring of isolators in aseptic processing Am Pharm Rev 13 1 92 96
    • (2010) Am Pharm Rev , vol.13 , Issue.1 , pp. 92-96
    • Akers, J.1
  • 8
    • 33646587345 scopus 로고    scopus 로고
    • Risk analysis for aseptic processing: The Akers-Agalloco
    • J Akers J Agalloco 2005 Risk analysis for aseptic processing: the Akers-Agalloco Method PharmTech 29 11 74 88
    • (2005) Method PharmTech , vol.29 , Issue.11 , pp. 74-88
    • Akers, J.1    Agalloco, J.2
  • 10
    • 57349146293 scopus 로고    scopus 로고
    • Product real time release for the microbial critical quality attribute using QbD approach
    • G Dalmaso 2008 Product real time release for the microbial critical quality attribute using QbD approach Amer Pharm Rev. 11 3 10 16
    • (2008) Amer Pharm Rev. , vol.11 , Issue.3 , pp. 10-16
    • Dalmaso, G.1
  • 11
    • 79954416081 scopus 로고    scopus 로고
    • Geneva, Switzerland, International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use
    • ICH Q10 Pharmaceutical Quality System. Geneva, Switzerland, International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. 2008. http://www.ich.org/LOB/media/MEDIA3917.pdf.
    • (2008) ICH Q10 Pharmaceutical Quality System
  • 12
    • 55749108399 scopus 로고    scopus 로고
    • Opportunities for rapid microbial methods
    • AM Cundell 2006 Opportunities for rapid microbial methods Am Pharm Rev 9 7 50 56
    • (2006) Am Pharm Rev , vol.9 , Issue.7 , pp. 50-56
    • Cundell, A.M.1
  • 14
    • 33749356703 scopus 로고    scopus 로고
    • Rapid microbiological methods and FDA's initiatives for pharmaceutical cGMP's for the 21st century, PAT, and sterile drug products produced by aseptic processing
    • MJ Miller 2005 Rapid microbiological methods and FDA's initiatives for pharmaceutical cGMP's for the 21st century, PAT and sterile drug products produced by aseptic processing Am Pharm Rev 8 1 104 107 (Pubitemid 44490962)
    • (2005) American Pharmaceutical Review , vol.8 , Issue.1 , pp. 104-107
    • Miller, M.J.1
  • 16
    • 74849125526 scopus 로고    scopus 로고
    • Rapid micro tests: It's about time/rapid micro tests can improve quality and efficiency
    • D Straus 2008 Rapid micro tests: it's about time/rapid micro tests can improve quality and efficiency Contam Control 4 2 23 27
    • (2008) Contam Control , vol.4 , Issue.2 , pp. 23-27
    • Straus, D.1
  • 17
    • 0000555764 scopus 로고    scopus 로고
    • Solid phase, laser scanning cytometry: A new two-hour method for the enumeration of microorganisms in pharmaceutical water
    • D Jones M Brailsford JL Drocourt 1999 Solid phase, laser scanning cytometry: a new two-hour method for the enumeration of microorganisms in pharmaceutical water Pharmacopeial Forum 25 1 7626 7645
    • (1999) Pharmacopeial Forum , vol.25 , Issue.1 , pp. 7626-7645
    • Jones, D.1    Brailsford, M.2    Drocourt, J.L.3
  • 18
    • 79954421998 scopus 로고    scopus 로고
    • Rapid enumeration of microorganisms using advanced analytical's RBD 3000
    • M. Miller (eds). PDA/Davis Healthcare Baltimore
    • Steger AM. Rapid enumeration of microorganisms using advanced analytical's RBD 3000. In: Miller M, editor. Encyclopedia of rapid microbiological methods. Vol. 2. Baltimore: PDA/Davis Healthcare; 2005. p. 379-96.
    • (2005) Encyclopedia of Rapid Microbiological Methods , vol.2 , pp. 379-396
    • Steger, A.M.1
  • 19
    • 37349082227 scopus 로고    scopus 로고
    • Enumeration of airborne bacteria and fungi using solid phase cytometry
    • DOI 10.1016/j.mimet.2007.10.004, PII S0167701207003466
    • L Vanhee H Nelis, et al. 2008 Enumeration of airborne bacteria and fungi using solid phase cytometry J Microbiol Meth 72 12 19 10.1016/j.mimet.2007.10. 004 1:CAS:528:DC%2BD1cXht12itA%3D%3D (Pubitemid 350309680)
    • (2008) Journal of Microbiological Methods , vol.72 , Issue.1 , pp. 12-19
    • Vanhee, L.M.E.1    Nelis, H.J.2    Coenye, T.3
  • 20
    • 35348853685 scopus 로고    scopus 로고
    • Evaluation of an instantaneous microbial detection system in controlled and cleanroom environments
    • VK Bhupathiraju B Varnau JR Nelson JP Jiang C Bolotin 2007 Evaluation of an instantaneous microbial detection system in controlled and cleanroom environments Biopharm Int. 21 9 35 46 (Pubitemid 47573233)
    • (2007) BioPharm International , vol.20 , Issue.9 , pp. 35-46
    • Bhupathiraju, V.K.1    Varnau, B.2    Nelson, J.R.3    Jiang, J.P.4    Bolotin, C.5
  • 21
    • 73449094349 scopus 로고    scopus 로고
    • Instantaneous microbial detection using optical spectroscopy
    • M. Miller (eds). PDA/Davis Healthcare International Baltimore
    • Jiang JP. Instantaneous microbial detection using optical spectroscopy. In: Miller M, editor. Encyclopedia of rapid microbiological methods. Vol. 3. Baltimore: PDA/Davis Healthcare International; 2005. p. 121-41.
    • (2005) Encyclopedia of Rapid Microbiological Methods , vol.3 , pp. 121-141
    • Jiang, J.P.1
  • 22
    • 38949121060 scopus 로고    scopus 로고
    • A PAT solution for water testing
    • 1:CAS:528:DC%2BD2sXht1yitr3P
    • MD Janke 2007 A PAT solution for water testing Innov Pharm Technol 23 112 118 1:CAS:528:DC%2BD2sXht1yitr3P
    • (2007) Innov Pharm Technol , vol.23 , pp. 112-118
    • Janke, M.D.1
  • 23
    • 79954423392 scopus 로고    scopus 로고
    • The growth direct test: A rapid, non-destructive, automated system for microbial enumeration
    • M. Miller (eds). PDA/Davis Healthcare International Baltimore
    • London R, Schwedock J, Sage A, et al. The growth direct test: a rapid, non-destructive, automated system for microbial enumeration. In: Miller M, editor. Encyclopedia of rapid microbiological methods. Vol. 1. Baltimore: PDA/Davis Healthcare International; 2005. p. 103-35.
    • (2005) Encyclopedia of Rapid Microbiological Methods , vol.1 , pp. 103-135
    • London, R.1    Schwedock, J.2    Sage, A.3
  • 25
    • 79954424261 scopus 로고    scopus 로고
    • Food and Drug Administration. FDA Rockville http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/default.htm Food and Drug Administration , Rockville: FDA
    • Food and Drug Administration 2010 Guidance for industry: submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes FDA Rockville http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ default.htm Food and Drug Administration. Guidance for industry: submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes. Rockville: FDA; 2010. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/default.htm.
    • (2010) Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.