Principles of parenteral solution validation : a practical lifecycle approach /

Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Gorsky, Igor (Editor ), Baseman, Harold, 1956- (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London, United Kingdom : Academic Press, 2020.
Colección:Expertise in pharmaceutical process technology series.
Temas:
Parenteral solutions > Quality control.
Drugs > Standards.
Drug development.
Quality control.
Drug Development
Drug Development > standards
Quality Control
Solutions (Pharmacie) > Administration parent�erale > Qualit�e > Contr�ole.
M�edicaments > Normes.
M�edicaments > D�eveloppement.
Qualit�e > Contr�ole.
quality control.
Quality control
Drug development
Drugs > Standards
Parenteral solutions > Quality control
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 1 Process Validation: Design and Planning
  • 2 Aseptic Process Validation: Aseptic Process Simulation Design
  • 3 Quality Risk Management of Parenteral Process Validation, Part 1: Fundamentals
  • 4 Equipment Cleaning Process
  • 5 Quality Risk Management of Parenteral Process Validation, Part 2: A Risk-Based Quality Management System
  • 6 Use of Statistics in Process Validation
  • 7 Process Validation Stage 1: Parenteral Process Design
  • 8 Process Validation Stage 2: Parenteral Process Performance Qualification
  • 9 Process Validation Stage 3: Continued Process Verification
  • 10 Preuse/Poststerilization Integrity Testing of Sterilizing Grade Filter
  • 11 Environmental Monitoring
  • 12 Isolators
  • 13 Post Aseptic Fill Sterilization and Lethal Treatment

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