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domingo, 26 de dezembro de 2010
REFERENCE
PDA Technical Report 34, (TR 34) Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products
domingo, 27 de junho de 2010
PARA LER - ENVIRONMENTAL MONITORING PROGRAMS
PDA - 2001 - PDA Tech Report #13 (Revised): Fundamentals of an Environmental Monitoring Program
EU-2008 - Eudralex The Rules Governing Medical Products in the European Union Volume 4: EU Guidelines to Good Manufacturing Practice Medical Products for Human and Veterinary Use: Annex 1 Manufacture of Sterile Medical Products.
PICS, 2004. PI-006-2 - Recomendations on VMP, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation.
USP 1116 - Microbioogical Control and Monitoring Environments Used for the Manufacture of Healthcare Products
EU-2008 - Eudralex The Rules Governing Medical Products in the European Union Volume 4: EU Guidelines to Good Manufacturing Practice Medical Products for Human and Veterinary Use: Annex 1 Manufacture of Sterile Medical Products.
PICS, 2004. PI-006-2 - Recomendations on VMP, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation.
USP 1116 - Microbioogical Control and Monitoring Environments Used for the Manufacture of Healthcare Products
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